Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of PhysiciansFREE
Publication: Annals of Internal Medicine
Volume 166, Number 7
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Abstract
Description:
The American College of Physicians (ACP) developed this guideline to present the evidence and provide clinical recommendations on noninvasive treatment of low back pain.
Methods:
Using the ACP grading system, the committee based these recommendations on a systematic review of randomized, controlled trials and systematic reviews published through April 2015 on noninvasive pharmacologic and nonpharmacologic treatments for low back pain. Updated searches were performed through November 2016. Clinical outcomes evaluated included reduction or elimination of low back pain, improvement in back-specific and overall function, improvement in health-related quality of life, reduction in work disability and return to work, global improvement, number of back pain episodes or time between episodes, patient satisfaction, and adverse effects.
Target Audience and Patient Population:
The target audience for this guideline includes all clinicians, and the target patient population includes adults with acute, subacute, or chronic low back pain.
Recommendation 1:
Given that most patients with acute or subacute low back pain improve over time regardless of treatment, clinicians and patients should select nonpharmacologic treatment with superficial heat (moderate-quality evidence), massage, acupuncture, or spinal manipulation (low-quality evidence). If pharmacologic treatment is desired, clinicians and patients should select nonsteroidal anti-inflammatory drugs or skeletal muscle relaxants (moderate-quality evidence). (Grade: strong recommendation)
Recommendation 2:
For patients with chronic low back pain, clinicians and patients should initially select nonpharmacologic treatment with exercise, multidisciplinary rehabilitation, acupuncture, mindfulness-based stress reduction (moderate-quality evidence), tai chi, yoga, motor control exercise, progressive relaxation, electromyography biofeedback, low-level laser therapy, operant therapy, cognitive behavioral therapy, or spinal manipulation (low-quality evidence). (Grade: strong recommendation)
Recommendation 3:
In patients with chronic low back pain who have had an inadequate response to nonpharmacologic therapy, clinicians and patients should consider pharmacologic treatment with nonsteroidal anti-inflammatory drugs as first-line therapy, or tramadol or duloxetine as second-line therapy. Clinicians should only consider opioids as an option in patients who have failed the aforementioned treatments and only if the potential benefits outweigh the risks for individual patients and after a discussion of known risks and realistic benefits with patients. (Grade: weak recommendation, moderate-quality evidence)
Low back pain is one of the most common reasons for physician visits in the United States. Most Americans have experienced low back pain, and approximately one quarter of U.S. adults reported having low back pain lasting at least 1 day in the past 3 months (1). Low back pain is associated with high costs, including those related to health care and indirect costs from missed work or reduced productivity (2). The total costs attributable to low back pain in the United States were estimated at $100 billion in 2006, two thirds of which were indirect costs of lost wages and productivity (3).
Low back pain is frequently classified and treated on the basis of symptom duration, potential cause, presence or absence of radicular symptoms, and corresponding anatomical or radiographic abnormalities. Acute back pain is defined as lasting less than 4 weeks, subacute back pain lasts 4 to 12 weeks, and chronic back pain lasts more than 12 weeks. Radicular low back pain results in lower extremity pain, paresthesia, and/or weakness and is a result of nerve root impingement. Most patients with acute back pain have self-limited episodes that resolve on their own; many do not seek medical care (4). For patients who do seek medical care, pain, disability, and return to work typically improve rapidly in the first month (5). However, up to one third of patients report persistent back pain of at least moderate intensity 1 year after an acute episode, and 1 in 5 report substantial limitations in activity (6). Many noninvasive treatment options are available for radicular and nonradicular low back pain, including pharmacologic and nonpharmacologic interventions.
Guideline Focus and Target Population
The purpose of this American College of Physicians (ACP) guideline is to provide treatment guidance based on the efficacy, comparative effectiveness, and safety of noninvasive pharmacologic and nonpharmacologic treatments for acute (<4 weeks), subacute (4 to 12 weeks), and chronic (>12 weeks) low back pain in primary care. This guideline does not address topical pharmacologic therapies or epidural injection therapies. It serves as a partial update of the 2007 ACP guideline (it excludes evidence on diagnosis). These recommendations are based on 2 background evidence reviews (7, 8) and a systematic review sponsored by the Agency for Healthcare Research and Quality (AHRQ) (9). The target audience for this guideline includes all clinicians, and the target patient population includes adults with acute, subacute, or chronic low back pain.
Methods
Systematic Review of the Evidence
The evidence review was conducted by the AHRQ's Pacific Northwest Evidence-based Practice Center. Additional methodological details can be found in the Appendix as well as in the accompanying articles (7, 8) and full report (9). Reviewers searched several databases for studies published in English from January 2008 through April 2015 and updated the search through November 2016. Studies published before 2007 were identified using the 2007 ACP/American Pain Society (APS) systematic reviews (10, 11). Reviewers combined data when possible using meta-analysis and assessed risk of bias and study quality according to established methods. The study population included adults (aged ≥18 years) with acute, subacute, or chronic nonradicular low back pain, radicular low back pain, or symptomatic spinal stenosis.
The review evaluated pharmacologic (acetaminophen, nonsteroidal anti-inflammatory drugs [NSAIDs], opioids, skeletal muscle relaxants [SMRs], benzodiazepines, antidepressants, antiseizure medications, and systemic corticosteroids) and nonpharmacologic (psychological therapies, multidisciplinary rehabilitation, spinal manipulation, acupuncture, massage, exercise and related therapies, and various physical modalities) treatments for low back pain. Evaluated outcomes included reduction or elimination of low back pain, improvement in back-specific and overall function, improvement in health-related quality of life, reduction in work disability, return to work, global improvement, number of back pain episodes or time between episodes, patient satisfaction, and adverse effects.
The magnitude of effect (small, moderate, or large) was determined as previously described (10, 11). A small effect on pain was defined as a mean between-group difference after treatment of 5 to 10 points on a visual analogue scale of 0 to 100 or equivalent, a mean between-group difference of 0.5 to 1.0 point on a numerical rating scale of 0 to 10, or a standardized mean difference of 0.2 to 0.5. A moderate effect was defined as a mean between-group difference of greater than 10 to no more than 20 points on a visual analogue scale of 0 to 100 or equivalent, a mean between-group difference of greater than 1.0 to no more than 2.0 points on a numerical rating scale of 0 to 10 or equivalent, or a standardized mean difference greater than 0.5 but no more than 0.8. For function, a small effect was defined as a mean between-group difference of 5 to 10 points on the Oswestry Disability Index (ODI), a mean between-group difference of 1 to 2 points on the Roland Morris Disability Questionnaire (RDQ), or a standardized mean difference of 0.2 to 0.5. A moderate effect on function was defined as a mean between-group difference of greater than 10 to no more than 20 points on the ODI, a mean between-group difference of greater than 2 to no more than 5 points on the RDQ, or a standardized mean difference greater than 0.5 but no more than 0.8. No large effects were found with any intervention.
Grading the Evidence and Developing Recommendations
This guideline was developed by ACP's Clinical Guidelines Committee (CGC) according to ACP's guideline development process, details of which can be found in the methods paper (12). The CGC used the evidence tables in the accompanying evidence reviews (7, 8) and full report (9) when reporting the evidence and graded the recommendations using the ACP's guideline grading system (Table).
Peer Review
The AHRQ systematic review was sent to invited peer reviewers and posted on the AHRQ Web site for public comments. The accompanying evidence reviews (7, 8) also underwent a peer review process through the journal. The guideline underwent a peer review process through the journal and was posted online for comments from ACP Regents and ACP Governors, who represent ACP members at the regional level.
Benefits and Comparative Benefits of Pharmacologic Therapies
Acute or Subacute Low Back Pain
Appendix Table 1 summarizes the findings for all therapies for acute or subacute low back pain.
Acetaminophen
NSAIDs
Moderate-quality evidence showed that NSAIDs were associated with a small improvement in pain intensity compared with placebo (14, 15), although several randomized, controlled trials (RCTs) showed no difference in likelihood of achieving pain relief with NSAIDs compared with placebo (16–18). Low-quality evidence showed a small increase in function with NSAIDs compared with placebo (19). Moderate-quality evidence showed that most head-to-head trials of one NSAID versus another showed no differences in pain relief in patients with acute low back pain (14). Low-quality evidence showed no differences in pain between cyclooxygenase (COX)-2–selective NSAIDs versus traditional NSAIDs (14).
SMRs
Moderate-quality evidence showed that SMRs improved short-term pain relief compared with placebo after 2 to 4 and 5 to 7 days (20, 21). Low-quality evidence showed no differences between different SMRs for any outcomes in patients with acute pain (20). Low-quality evidence showed inconsistent findings for the effect on pain intensity with a combination of SMRs plus NSAIDs compared with NSAIDs alone (20, 22, 23).
Systemic Corticosteroids
Other Therapies
Chronic Low Back Pain
Appendix Table 2 summarizes the findings for all therapies for chronic low back pain.
NSAIDs
Moderate-quality evidence showed that NSAIDs were associated with small to moderate pain improvement compared with placebo (14, 28, 29). Low-quality evidence showed that NSAIDs were associated with no to small improvement in function (28–31). Moderate-quality evidence showed that most head-to-head trials of one NSAID versus another showed no differences in pain relief in patients with chronic low back pain (14). There were no data on COX-2–selective NSAIDs.
Opioids
Moderate-quality evidence showed that strong opioids (tapentadol, morphine, hydromorphone, and oxymorphone) were associated with a small short-term improvement in pain scores (about 1 point on a pain scale of 0 to 10) and function compared with placebo (32–36). Low-quality evidence showed that buprenorphine patches improved short-term pain more than placebo in patients with chronic low back pain; however, the improvement corresponded to less than 1 point on a pain scale of 0 to 10 (37–40). Moderate-quality evidence showed no differences among different long-acting opioids for pain or function (33, 41–44), and low-quality evidence showed no clear differences in pain relief between long- and short-acting opioids (45–50). Moderate-quality evidence showed that tramadol achieved moderate short-term pain relief and a small improvement in function compared with placebo (32, 51, 52).
SMRs
Benzodiazepines
Low-quality evidence showed that tetrazepam improved pain relief at 5 to 7 days and resulted in overall improvement at 10 to 14 days compared with placebo (20).
Antidepressants
Moderate-quality evidence showed no difference in pain between tricyclic antidepressants (TCAs) or selective serotonin reuptake inhibitors (SSRIs) versus placebo, and low-quality evidence showed no differences in function for antidepressants (56). Moderate-quality evidence showed that duloxetine was associated with a small improvement in pain intensity and function compared with placebo (57–59).
Other Therapies
Evidence was insufficient to determine the effect of acetaminophen, systemic corticosteroids, or antiseizure medications on chronic low back pain.
Radicular Low Back Pain
Appendix Table 3 summarizes the findings for all treatments for radicular low back pain.
Benzodiazepines
Low-quality evidence showed no difference between diazepam and placebo for function at 1 week through 1 year and analgesic use, return to work, or likelihood of surgery through 1 year of follow-up in patients with acute or subacute radicular pain (60). Diazepam resulted in a lower likelihood of pain improvement at 1 week compared with placebo.
Systemic Corticosteroids
Moderate-quality evidence showed no differences in pain between systemic corticosteroids and placebo and no to small effect on function in patients with radicular low back pain (61–66).
Other Therapies
No RCTs evaluated acetaminophen, SMRs, antidepressants, or opioids for radicular low back pain. Results for NSAIDs were inconsistent for pain, and evidence was therefore insufficient (22). There was insufficient evidence to determine the effect of antiseizure medications on radicular low back pain (67–71).
Harms of Pharmacologic Therapies
Harms were derived from the identified systematic reviews. Adverse effects generally associated with the drugs can be found in Appendix Table 4.
Moderate-quality evidence showed no difference among scheduled acetaminophen, acetaminophen taken as needed, or placebo for serious adverse events (13). Moderate-quality evidence showed that more adverse effects occurred with NSAIDs than placebo, COX-2–selective NSAIDs were associated with a decreased risk for adverse effects compared with traditional NSAIDs, and acetaminophen was associated with a lower risk for adverse effects than NSAIDs (14). Moderate-quality evidence showed that short-term use of opioids increased nausea, dizziness, constipation, vomiting, somnolence, and dry mouth compared with placebo, and SMRs increased risk for any adverse event and central nervous system adverse events (mostly sedation) compared with placebo (20). Moderate-quality evidence showed that antidepressants increased risk for any adverse event compared with placebo, although rates of specific adverse events did not differ (72). The risk for serious adverse events did not differ between duloxetine and placebo, although duloxetine was associated with increased risk for withdrawal due to adverse events (57–59). Low-quality evidence showed no clear differences in adverse effects for gabapentin versus placebo (67, 68). Low-quality evidence showed that benzodiazepines caused more frequent somnolence, fatigue, and lightheadedness than placebo (20). Harms were not well-reported, and no RCTs assessed long-term use of benzodiazepines or risks for addiction, abuse, or overdose. Adverse events for systemic corticosteroids were not well-reported in RCTs, but the largest trial found that oral prednisone was associated with increased risk for any adverse event, insomnia, nervousness, and increased appetite (66). However, low-quality evidence showed no cases of hyperglycemia that required medical attention (24, 61, 64).
Comparative Benefits of Nonpharmacologic Therapies
Acute or Subacute Low Back Pain
Exercise
Low-quality evidence showed no difference between exercise therapy and usual care for pain or function in patients with acute or subacute pain (11); additional trials reported inconsistent results (73–75). Moderate-quality evidence showed no clear differences between different exercise regimens in more than 20 head-to-head RCTs in patients with acute low back pain.
Acupuncture
Low-quality evidence showed that acupuncture resulted in a small decrease in pain intensity compared with sham acupuncture with nonpenetrating needles, but there were no clear effects on function (76–78). Low-quality evidence showed that acupuncture slightly increased the likelihood of overall improvement compared with NSAIDs (76, 79–83).
Massage
Low-quality evidence showed that massage moderately improved short-term (1 week) pain and function compared with sham therapy for subacute low back pain (84), although 1 trial (85) showed no difference in pain or function at 5 weeks. Moderate-quality evidence showed that massage improved short-term pain relief and function compared with other interventions (manipulation, exercise therapy, relaxation therapy, acupuncture, or physiotherapy) for patients with subacute to chronic low back pain, but effects were small (84, 86). Low-quality evidence showed that a combination of massage plus another intervention (exercise, exercise and education, or usual care) was superior to the other intervention alone for short-term pain in patients with subacute to chronic low back pain (84).
Spinal Manipulation
Low-quality evidence showed that spinal manipulation was associated with a small effect on function compared with sham manipulation; evidence was insufficient to determine the effect on pain (87, 88). Low-quality evidence showed no difference in pain relief at 1 week between spinal manipulation and inert treatment (educational booklet, detuned ultrasound, detuned or actual short-wave diathermy, antiedema gel, or bed rest), although 1 trial showed better longer-term pain relief (3 months) with spinal manipulation (89). Function did not differ between spinal manipulation and inert treatment at 1 week or 3 months (89). Moderate-quality evidence showed no difference between spinal manipulation and other active interventions for pain relief at 1 week through 1 year or function (analyses included exercise, physical therapy, or back school as the comparator) (89, 90). Low-quality evidence showed that a combination of spinal manipulation plus exercise or advice slightly improved function at 1 week compared with exercise or advice alone, but these differences were not present at 1 or 3 months (89).
Superficial Heat
Moderate-quality evidence showed that a heat wrap moderately improved pain relief (at 5 days) and disability (at 4 days) compared with placebo (91). Low-quality evidence showed that a combination of heat plus exercise provided greater pain relief and improved RDQ scores at 7 days compared with exercise alone in patients with acute pain (92). Low-quality evidence showed that a heat wrap provided more effective pain relief and improved RDQ scores compared with acetaminophen or ibuprofen after 1 to 2 days (93). Low-quality evidence showed no clear differences between a heat wrap and exercise in pain relief or function (92).
Low-Level Laser Therapy
Low-quality evidence showed that a combination of low-level laser therapy (LLLT) and NSAIDs largely decreased pain intensity and resulted in a moderate improvement in function (as measured by the ODI) compared with sham laser therapy plus NSAIDs in patients with acute or subacute pain (94).
Lumbar Supports
Low-quality evidence showed no difference in pain or function between lumbar supports added to an educational program compared with an educational program alone or other active interventions in patients with acute or subacute low back pain (95).
Other Therapies
Evidence was insufficient to determine the effectiveness of transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation, inferential therapy, short-wave diathermy, traction, superficial cold, motor control exercise (MCE), Pilates, tai chi, yoga, psychological therapies, multidisciplinary rehabilitation, ultrasound, and taping.
Chronic Low Back Pain
Exercise
Moderate-quality evidence showed that exercise resulted in a small improvement in pain relief and function compared with no exercise (11, 96). Moderate-quality evidence showed that compared with usual care, exercise resulted in small improvements in pain intensity and function at the end of treatment, although effects were smaller at long-term follow-up (96). Moderate-quality evidence showed no clear differences between different exercise regimens in more than 20 head-to-head RCTs in patients with chronic low back pain.
MCE
Motor control exercise focuses on restoring coordination, control, and strength of the muscles that control and support the spine. Low-quality evidence showed that MCE moderately decreased pain scores and slightly improved function in short- to long-term follow-up compared with a minimal intervention (97). Low-quality evidence showed that MCE resulted in small improvements in pain intensity at short-term (≥6 weeks to <4 months) and intermediate-term (≥4 to <8 months) follow-up compared with general exercise, although improvements were small and no longer significant at long-term follow-up (97). Motor control exercise also resulted in small improvements in function in the short and long term (97). Low-quality evidence showed that MCE resulted in a moderate improvement in pain intensity and function compared with multimodal physical therapy at intermediate follow-up (97). Low-quality evidence showed no clear differences in pain with a combination of MCE plus exercise versus exercise alone (98, 99).
Pilates
Low-quality evidence showed that Pilates resulted in small or no clear effects on pain and no clear effects on function compared with usual care plus physical activity (100–107). Low-quality evidence showed no clear differences between Pilates and other types of exercise for pain or function (108–110).
Tai Chi
Low-quality evidence showed that tai chi resulted in moderate pain improvement compared with wait-list controls or no tai chi (111, 112), and 1 study showed a small increase in function (111). Moderate-quality evidence showed that tai chi moderately decreased pain intensity at 3 and 6 months compared with backward walking or jogging but not versus swimming (112).
Yoga
Low-quality evidence showed that Iyengar yoga resulted in moderately lower pain scores and improved function compared with usual care at 24 weeks (113). Low-quality evidence showed that yoga resulted in a small decrease in pain intensity compared with exercise (114–118). Low-quality evidence showed that, compared with education, yoga resulted in a small decrease in short-term (≤12 weeks) but not long-term (about 1 year) pain intensity and a small increase in short- and long-term function (119).
Psychological Therapies
Low-quality evidence showed that progressive relaxation therapy moderately improved pain intensity and functional status compared with wait-list controls (120). Low-quality evidence showed that electromyography biofeedback training moderately decreased pain intensity (reduction of 5 to 13 points on a 100-point pain scale) compared with wait-list controls, but there was no effect on function (120). Low-quality evidence showed that operant therapy (behavioral therapy involving reinforcement) slightly improved pain intensity compared with wait-list control, although there was no difference for function (120). Low-quality evidence showed that cognitive behavioral therapy (CBT) and other combined psychological therapies (involving education, problem-solving training, coping techniques, imagery, relaxation, goal setting, cognitive pain control, and exercises) were associated with moderately improved pain intensity compared with wait-list controls, but there was no difference in function (120). Moderate-quality evidence showed that mindfulness-based stress reduction is an effective treatment for chronic low back pain. One study showed a small improvement in pain at 26 and 52 weeks and in function at 26 weeks compared with usual care (121). The same study showed no difference between mindfulness-based stress reduction and CBT for improvements in pain or function. Two other studies showed improvement in pain and function compared with education (122, 123). Low-quality evidence showed no difference between psychological therapies and exercise or physical therapy for pain intensity (120). Low-quality evidence showed no differences in pain or function between a combination of psychological therapy plus exercise or physiotherapy compared with exercise or physiotherapy alone (120). Moderate-quality evidence showed no differences between different psychological therapies for pain or function outcomes (120).
Multidisciplinary Rehabilitation
Moderate-quality evidence showed that multidisciplinary rehabilitation moderately reduced short-term (<3 months) and slightly reduced long-term pain intensity and disability compared with usual care, although there was no difference in return to work (124). Low-quality evidence showed that multidisciplinary rehabilitation was associated with moderately lower short-term pain intensity and slightly lower disability than no rehabilitation (124). Moderate-quality evidence showed that multidisciplinary rehabilitation was associated with slightly lower short-term pain intensity and disability, moderately lower long-term pain intensity, and improved function compared with physical therapy and a greater likelihood of returning to work compared with nonmultidisciplinary rehabilitation (124).
Acupuncture
Low-quality evidence showed that acupuncture was associated with moderate improvement in pain relief immediately after treatment and up to 12 weeks later compared with sham acupuncture, but there was no improvement in function (125–130). Moderate-quality evidence showed that acupuncture was associated with moderately lower pain intensity and improved function compared with no acupuncture at the end of treatment (125). Low-quality evidence showed a small improvement in pain relief and function compared with medications (NSAIDs, muscle relaxants, or analgesics) (125).
Massage
Low-quality evidence showed no difference in pain between foot reflexology and usual care for patients with chronic low back pain (131–133). Moderate-quality evidence showed that massage improved short-term pain relief and function compared with other interventions (manipulation, exercise therapy, relaxation therapy, acupuncture, physiotherapy, or TENS) for patients with subacute to chronic low back pain, although effects were small (84, 86). Low-quality evidence showed that a combination of massage plus another intervention (exercise, exercise and education, or usual care) was superior to the other intervention alone for short-term pain in patients with subacute to chronic low back pain (84).
Spinal Manipulation
Low-quality evidence showed no difference in pain with spinal manipulation versus sham manipulation at 1 month (134, 135). Low-quality evidence showed that spinal manipulation slightly improved pain compared with an inert treatment (136–142). Moderate-quality evidence showed no clear differences in pain or function compared with another active intervention. Low-quality evidence showed that a combination of spinal manipulation with another active treatment resulted in greater pain relief and improved function at 1, 3, and 12 months compared with the other treatment alone (134, 143–147).
Ultrasound
TENS
LLLT
Lumbar Support
Evidence was insufficient to compare lumbar support versus no lumbar support. Low-quality evidence showed no difference between a lumbar support plus exercise (muscle strengthening) versus exercise alone for pain or function at 8 weeks or 6 months (158). Low-quality evidence showed no clear differences between lumbar supports and other active treatments (traction, spinal manipulation, exercise, physiotherapy, or TENS) for pain or function (159–161).
Taping
Low-quality evidence showed no differences between Kinesio taping and sham taping for back-specific function after 5 or 12 weeks, although effects on pain were inconsistent between the 2 trials (162, 163). Low-quality evidence showed no differences between Kinesio taping and exercise for pain or function (164, 165).
Other Therapies
Evidence was insufficient to determine the effectiveness of electrical muscle stimulation, interferential therapy, short-wave diathermy, traction, or superficial heat or cold.
Radicular Low Back Pain
Exercise
Low-quality evidence showed that exercise resulted in small improvements in pain and function compared with usual care or no exercise (166–168).
Traction
Low-quality evidence showed no clear differences between traction and other active treatments, between traction plus physiotherapy versus physiotherapy alone, or between different types of traction in patients with low back pain with or without radiculopathy (169).
Other Therapies
Evidence was insufficient for ultrasound, MCE, Pilates, tai chi, yoga, psychological therapies, multidisciplinary rehabilitation, acupuncture, massage, spinal manipulation, LLLT, electrical muscle stimulation, short-wave diathermy, TENS, interferential therapy, superficial heat or cold, lumbar support, and taping.
Harms of Nonpharmacologic Therapies
Evidence on adverse events from the included RCTs and systematic reviews was limited, and the quality of evidence for all available harms data is low. Harms were poorly reported (if they were reported at all) for most of the interventions.
Low-quality evidence showed no reported harms or serious adverse events associated with tai chi, psychological interventions, multidisciplinary rehabilitation, ultrasound, acupuncture, lumbar support, or traction (9, 95, 150, 170–174). Low-quality evidence showed that when harms were reported for exercise, they were often related to muscle soreness and increased pain, and no serious harms were reported. All reported harms associated with yoga were mild to moderate (119). Low-quality evidence showed that none of the RCTs reported any serious adverse events with massage, although 2 RCTs reported soreness during or after massage therapy (175, 176). Adverse events associated with spinal manipulation included muscle soreness or transient increases in pain (134). There were few adverse events reported and no clear differences between MCE and controls. Transcutaneous electrical nerve stimulation was associated with an increased risk for skin site reaction but not serious adverse events (177). Two RCTs (178, 179) showed an increased risk for skin flushing with heat compared with no heat or placebo, and no serious adverse events were reported. There were no data on cold therapy. Evidence was insufficient to determine harms of electrical muscle stimulation, LLLT, percutaneous electrical nerve stimulation, interferential therapy, short-wave diathermy, and taping.
Comparison of Conclusions With Those of the 2007 Guideline
Some evidence has changed since the 2007 ACP guideline and supporting evidence review. The 2007 review concluded that acetaminophen was effective for acute low back pain, based on indirect evidence from trials of acetaminophen for other conditions and trials of acetaminophen versus other analgesics. However, this update included a placebo-controlled RCT in patients with low back pain that showed no difference in effectiveness between acetaminophen and placebo (low-quality evidence). In addition, contrary to the 2007 review, current moderate-quality evidence showed that TCAs were not effective for chronic low back pain compared with placebo. Additional pharmacologic treatments addressed in the current review included duloxetine and the antiseizure medication pregabalin. Many conclusions about nonpharmacologic interventions are similar between the 2007 review and the update. Additional modalities assessed (with at least low-quality evidence) include mindfulness-based stress reduction, MCE, taping, and tai chi. Additional evidence or changes from the updated review include that superficial heat was found to be more effective for acute or subacute low back pain (moderate-quality evidence) and neither ultrasound nor TENS was shown to be effective compared with controls (low-quality evidence).
The Figure summarizes the recommendations and clinical considerations. Additional details on the evidence are available in Appendix Tables 1, 2, 3 and 4 and the accompanying evidence reviews (7, 8).
Figure. Summary of the American College of Physicians guideline on noninvasive treatments for acute, subacute, or chronic low back pain.
COX-2 = cyclooxygenase-2; LLLT = low-level laser therapy; NSAID = nonsteroidal anti-inflammatory drug; SMR = skeletal muscle relaxant.
Recommendations
Recommendation 1: Given that most patients with acute or subacute low back pain improve over time regardless of treatment, clinicians and patients should select nonpharmacologic treatment with superficial heat (moderate-quality evidence), massage, acupuncture, or spinal manipulation (low-quality evidence). If pharmacologic treatment is desired, clinicians and patients should select nonsteroidal anti-inflammatory drugs or skeletal muscle relaxants (moderate-quality evidence). (Grade: strong recommendation)
Clinicians should inform all patients of the generally favorable prognosis of acute low back pain with or without sciatica, including a high likelihood for substantial improvement in the first month (5, 180). Clinicians should also provide patients with evidence-based information with regard to their expected course, advise them to remain active as tolerated, and provide information about effective self-care options. Clinicians and patients should use a shared decision-making approach to select the most appropriate treatment based on patient preferences, availability, harms, and costs of the interventions. Nonpharmacologic interventions shown to be effective for improving pain and function in patients with acute or subacute low back pain include superficial heat (moderate-quality evidence and moderate improvement in pain and function) and massage (low-quality evidence and small to moderate improvement in pain and function). Low-quality evidence showed that acupuncture had a small effect on improving pain and spinal manipulation had a small effect on improving function compared with sham manipulation but not inert treatment. Harms of nonpharmacologic interventions were sparsely reported, and no serious adverse events were reported. Superficial heat was associated with increased risk for skin flushing, and massage and spinal manipulation were associated with muscle soreness.
We recommend that the choice between NSAIDs and SMRs be individualized on the basis of patient preferences and likely individual medication risk profile. Treatment with NSAIDs resulted in a small improvement in both pain intensity (moderate-quality evidence) and function (low-quality evidence), and treatment with SMRs resulted in a small improvement in pain relief (moderate-quality evidence). There was no evidence for the effect of SMRs on function. Nonsteroidal anti-inflammatory drugs are associated with gastrointestinal and renal risks. Clinicians should therefore assess renovascular and gastrointestinal risk factors before prescribing NSAIDs and recommend the lowest effective doses for the shortest periods necessary. Although they are associated with lower risk for adverse effects than nonselective NSAIDs, COX-2–selective NSAIDs were not assessed for improvement in pain or function. Skeletal muscle relaxants are associated with central nervous system adverse effects, especially sedation.
The updated evidence showed that acetaminophen was not effective at improving pain outcomes versus placebo. However, this study assessed pain at 3 weeks after the intervention, and evidence from head-to-head trials showed no difference between acetaminophen and NSAIDs. Low-quality evidence showed that systemic steroids were not effective in treating acute or subacute low back pain, and we recommend against these drugs for treatment of acute low back pain.
Recommendation 2: For patients with chronic low back pain, clinicians and patients should initially select nonpharmacologic treatment with exercise, multidisciplinary rehabilitation, acupuncture, mindfulness-based stress reduction (moderate-quality evidence), tai chi, yoga, motor control exercise, progressive relaxation, electromyography biofeedback, low-level laser therapy, operant therapy, cognitive behavioral therapy, or spinal manipulation (low-quality evidence). (Grade: strong recommendation)
Nonpharmacologic interventions are considered as first-line options in patients with chronic low back pain because fewer harms are associated with these types of therapies than with pharmacologic options. It is important that physical therapies be administered by providers with appropriate training. Moderate-quality evidence showed that exercise therapy resulted in small improvements in pain and function. Specific components associated with greater effects on pain included individually designed programs, supervised home exercise, and group exercise; regimens that included stretching and strength training were most effective. Moderate-quality evidence showed that, compared with usual care, multidisciplinary rehabilitation resulted in moderate pain improvement in the short term (<3 months), small pain improvement in the long term, and small improvement in function in both the short and long term. Low-quality evidence showed that multidisciplinary rehabilitation resulted in a moderate improvement in pain and a small improvement in function compared with no multidisciplinary rehabilitation. Acupuncture had a moderate effect on pain and function compared with no acupuncture (moderate-quality evidence) and a moderate effect on pain with no clear effect on function compared with sham acupuncture (low-quality evidence). Moderate-quality evidence showed that mindfulness-based stress reduction resulted in small improvements in pain and function (small effect), and 1 study showed that it was equivalent to CBT for improving back pain and function.
Low-quality evidence showed that tai chi had a moderate effect on pain and a small effect on function. Tai chi sessions in included studies lasted 40 to 45 minutes and were done 2 to 5 times per week for 10 to 24 weeks. Low-quality evidence showed that yoga improved pain and function by a moderate amount compared with usual care and by a small amount compared with education. Low-quality evidence showed that MCE had a moderate effect on pain and a small effect on function. Motor control exercise, tai chi, and yoga were favored over general exercise (low-quality evidence).
Low-quality evidence showed that progressive relaxation had a moderate effect on pain and function, electromyography biofeedback and CBT each had a moderate effect on pain and no effect on function, and operant therapy had a small effect on pain and no effect on function. Low-quality evidence showed that LLLT had a small effect on pain and function. Low-quality evidence showed that spinal manipulation had a small effect on pain compared with inert treatment but no effect compared with sham manipulation. There were no clear differences between spinal manipulation and other active interventions (moderate-quality evidence).
Harms were poorly reported for nonpharmacologic therapies, although no serious harms were reported for any of the recommended interventions. Muscle soreness was reported for exercise, massage, and spinal manipulation.
Ultrasound, TENS, and Kinesio taping had no effect on pain or function compared with control treatments (low-quality evidence).
Recommendation 3: In patients with chronic low back pain who have had an inadequate response to nonpharmacologic therapy, clinicians and patients should consider pharmacologic treatment with nonsteroidal anti-inflammatory drugs as first-line therapy, or tramadol or duloxetine as second-line therapy. Clinicians should only consider opioids as an option in patients who have failed the aforementioned treatments and only if the potential benefits outweigh the risks for individual patients and after a discussion of known risks and realistic benefits with patients. (Grade: weak recommendation, moderate-quality evidence)
Pharmacologic therapy should be considered for patients with chronic low back pain who do not improve with nonpharmacologic interventions. Nonsteroidal anti-inflammatory drugs had a small to moderate effect on pain (moderate-quality evidence) and no to small effect on function (low-quality evidence) and should be the first option considered. Moderate-quality evidence showed no difference in pain improvement when different NSAIDs were compared with one another. Nonsteroidal anti-inflammatory drugs are associated with gastrointestinal and renal risks. Clinicians should therefore assess renovascular and gastrointestinal risk factors before prescribing NSAIDs and should recommend the lowest effective doses for the shortest periods necessary. COX-2–selective NSAIDs were not assessed for improvement in pain or function, although they are associated with lower risk for adverse effects than nonselective NSAIDs.
For second-line therapies, moderate-quality evidence showed that tramadol had a moderate effect on pain and a small effect on function in the short term. Of note, tramadol is a narcotic and, like other opioids, is associated with the risk for abuse (181). Moderate-quality evidence showed that duloxetine had a small effect on pain and function.
Moderate-quality evidence showed that opioids (morphine, oxymorphone, hydromorphone, and tapentadol) had a small effect on short-term pain and function. Low-quality evidence showed that buprenorphine (patch or sublingual) resulted in a small improvement in pain. Opioids should be the last treatment option considered and should be considered only in patients for whom other therapies have failed because they are associated with substantial harms. Moderate-quality evidence showed no difference in pain or function when different long-acting opioids were compared with one another. Harms of short-term use of opioids include increased nausea, dizziness, constipation, vomiting, somnolence, and dry mouth compared with placebo. Studies assessing opioids for the treatment of chronic low back pain did not address the risk for addiction, abuse, or overdose, although observational studies have shown a dose-dependent relationship between opioid use for chronic pain and serious harms (182).
Moderate-quality evidence showed that TCAs did not effectively improve pain or function (low-quality evidence) in patients with chronic low back pain, which is contrary to the 2007 guideline. In addition, moderate-quality evidence showed that SSRIs did not improve pain.
Areas of Inconclusive Evidence
Evidence is insufficient or lacking to determine treatments for radicular low back pain. Most RCTs enrolled a mixture of patients with acute, subacute, and chronic low back pain, so it is difficult to extrapolate the benefits of treatment compared with its duration. Use of opioids for chronic pain is an important area that requires further research to compare benefits and harms of therapy. The evidence is also insufficient for most physical modalities. Evidence is insufficient on which patients are likely to benefit from which specific therapy. Evidence on patient-important outcomes, such as disability or return to work, was largely unavailable, and available evidence showed no clear connection with improvements in pain.
High-Value Care
Clinicians should reassure patients that acute or subacute low back pain usually improves over time, regardless of treatment. Thus, clinicians should avoid prescribing costly and potentially harmful treatments for these patients, especially narcotics. In addition, systemic steroids were not shown to provide benefit and should not be prescribed for patients with acute or subacute low back pain, even with radicular symptoms. For treatment of chronic low back pain, clinicians should select therapies that have the fewest harms and lowest costs because there were no clear comparative advantages for most treatments compared with one another. Clinicians should avoid prescribing costly therapies; those with substantial potential harms, such as long-term opioids (which can be associated with addiction and accidental overdose); and pharmacologic therapies that were not shown to be effective, such as TCAs and SSRIs.
Appendix: Detailed Methods
The evidence review was conducted by the AHRQ's Pacific Northwest Evidence-based Practice Center. Details of the ACP guideline development process can be found in ACP's methods paper (12). Disclosures of interests and management of any conflicts can be found at www.acponline.org/clinical_information/guidelines/guidelines/conflicts_cgc.htm.
Key Questions Addressed
1. What are the comparative benefits and harms of different pharmacologic therapies for acute or chronic nonradicular low back pain, radicular low back pain, or spinal stenosis, including NSAIDs, acetaminophen, opioids, muscle relaxants, antiseizure medications, antidepressants, corticosteroids, and topical or patch-delivered medications?
2. What are the comparative benefits and harms of different nonpharmacologic, noninvasive therapies for acute or chronic nonradicular low back pain, radicular low back pain, or spinal stenosis, including but not limited to interdisciplinary rehabilitation, exercise (various types), physical modalities (ultrasound, TENS, electrical muscle stimulation, interferential therapy, heat [various forms], and ice), traction tables/devices, back supports/bracing, spinal manipulation, various psychological therapies, acupuncture, massage therapy (various types), yoga, magnets, and low-level lasers?
Search Strategy
Reviewers searched MEDLINE, the Cochrane Central Register of Controlled Trials, and the Cochrane Database of Systematic Reviews for trials published from January 2008 through April 2015. Searches were updated through November 2016. Studies published before 2008 were identified using the 2007 ACP/APS systematic reviews (10, 11).
Quality Assessment
Population Studied
Adults with acute, subacute, or chronic nonradicular low back pain, radicular low back pain, or symptomatic spinal stenosis.
Interventions Evaluated
Oral or topical pharmacologic therapies included NSAIDs, acetaminophen, opioids, tramadol and tapentadol, antidepressants, SMRs, benzodiazepines, corticosteroids, antiepileptic medications, capsaicin, and lidocaine.
Noninvasive, nonpharmacologic therapies included interdisciplinary or multicomponent rehabilitation (physical therapy plus psychological therapy with some coordination), psychological therapies, exercise and related interventions (such as yoga or tai chi), complementary and alternative medicine therapies (spinal manipulation, acupuncture, and massage), passive physical modalities (such as heat, cold, ultrasound, TENS, electrical muscle stimulation, interferential therapy, short-wave diathermy, traction, LLLT, and lumbar supports/braces), and taping.
Comparators
Interventions were compared with each other or with placebo (drug trials), sham (functionally inert) treatments, or no treatment.
Outcomes
Outcomes included reduction or elimination of low back pain (including related leg symptoms), improvement in back-specific and overall function, improvement in health-related quality of life, reduction in work disability and return to work, global improvement, number of back pain episodes or time between episodes, patient satisfaction, and adverse effects of interventions.
Timing
Timing of outcomes was stratified as long-term (≥1 year) and short-term (≤6 months).
Setting
Settings included inpatient and outpatient.
Target Audience
The target audience includes all clinicians.
Target Patient Population
The target patient population includes adults with acute (<4 weeks), subacute (4 to 12 weeks), or chronic (>12 weeks) nonradicular low back pain, radicular low back pain, or symptomatic spinal stenosis. Children or adolescents with low back pain; pregnant women; and patients with low back pain from sources outside the back (nonspinal low back pain), fibromyalgia or other myofascial pain syndromes, and thoracic or cervical back pain are not included.
Peer Review
The AHRQ systematic review was sent to invited peer reviewers and posted on the AHRQ Web site for public comments. The accompanying evidence reviews (7, 8) also underwent a peer review process through the journal. The guideline underwent a peer review process through the journal and was posted online for comments from ACP Regents and ACP Governors, who represent ACP members at the regional level.
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Annals of Internal Medicine
Volume 166 • Number 7 • 4 April 2017
Pages: 514 - 530
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Published online: 14 February 2017
Published in issue: 4 April 2017
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© 2017 American College of Physicians.
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Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med.2017;166:514-530. [Epub 14 February 2017]. doi:10.7326/M16-2367
Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med.2017;166:514-530. [Epub 14 February 2017]. doi:10.7326/M16-2367
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Comment
As someone about to enter a field that is frequently associated with, or considered a part of, complementary healthcare, I know first-hand how misguided and overblown the claims and hopes of acupuncture’s efficacy can be. Such claims are generally based on small and probably unmeaningful effects taken selectively from the total evidence. I have often seen my own mentors and peers pushing for the use of acupuncture for many chronic and serious conditions for which there is no basis of evidence at all of acupuncture’s efficacy, including systemic, neurological, and developmental conditions. When questioned, they will usually refer to authorities perceived as “legitimate”, including the ACP, to say that claims of acupuncture “working” are backed by experts.
We see a similar situation (as touched on in one of the comments above), with advertisers and media using the guise of “expert-backed” legitimization to recommend acupuncture in misleading ways, often to an audience of vulnerable people who could be making better-informed and more effective treatment and management choices for their conditions. Many of these entities specifically mention the ACP as lending credence to their claims, sometimes somewhat out of context.
I hope that you will reconsider your recommendation of a practice that is simply not supported by the majority of the research evidence that exists to date. Patients with complex conditions, including low-back pain, deserve accurate and realistic information regarding their treatment options, especially from such trusted and reputable sources as the ACP.
This comment is condensed from a longer open letter to the ACP that can be accessed, with further sourcing, via the reference below.
MacGregor, A. (14 May 2017). Acupuncture for back pain: an open letter by a Canadian therapist. Retrieved from http://edzardernst.com/2017/05/acupuncture-for-back-pain-an-open-letter-by-a-canadian-therapist/
Author's Response
We concur with Mr. Collen that there is both observational and meta-analytic evidence that suggests that NSAIDs may increase CV risk; however, as our review process is focused specifically on the setting of low back pain, we did not conduct independent evidence searches for the side effects of medications outside of the trials. This is an admitted limitation of our process and one that we will need to consider in future reviews. Mr. Collen also notes that psychosocial support is essential to throughout the recovery process and it likely might be the case, but the evidence review did not identify any such studies to support the recommendations.
Dr. Vucina notes that low back pain has heterogeneous causes, and that treatment may vary. We agree this is likely, but rarely addressed by current trials; further, there is no agreement on clear methods to define the source of low back pain, as symptoms and imaging findings are rarely determinative.
Dr. Murphy and colleagues advocate for “Primary Spine Practitioners (PSP)” to manage back pain. While we concur that the array of treatment options and the lack of head-to-head comparisons of these options makes choices difficult for physicians and patients, we would also comment that low back pain is so ubiquitous that training enough PSPs to care for back pain would be an undertaking of massive proportion. Ideally the options laid out in our guideline (2), along with the fact that most back pain is self-limited, would suffice for many patients, and rare referral would occur for more refractory cases.
We appreciate the updated review conducted by Drs. Le and Badgett. Given their findings, we would agree that tramadol would likely not have been recommended as a treatment option for chronic low back pain.
Sandeep Vijan, MD, MS
Ann Arbor VA HSR&D CCMR, Ann Arbor, MI
Scott Manaker, MD, PhD
Hospital of the University of Pennsylvania, Philadelphia, PA 19104
Amir Qaseem, MD, PhD, MHA
American College of Physicians, Philadelphia, Pennsylvania
References
1. Chou R, Deyo R, Friedly J, et al. Systemic pharmacologic therapies for low back pain: A systematic review for an American College of Physicians clinical practice guideline. Annals of Internal Medicine. 2017.
2. Qaseem A, Wilt TJ, McLean RM, Forciea M, for the Clinical Guidelines Committee of the American College of P. Noninvasive treatments for acute, subacute, and chronic low back pain: A clinical practice guideline from the American College of Physicians. Annals of Internal Medicine. 2017.
Comment
The recommendation of acupuncture in the Guideline was cited by several medical websites that aggregate news and by the media, which may mislead healthcare providers and the public. Endorsing a placebo therapy violates professionalism standards requiring use of the best evidence in guiding practice, and in enabling patients to make informed decisions about therapy. The lack of rigor in evaluating acupuncture raises concerns about other therapies listed in Recommendation 2.
The lack of truly effective pharmacologic or nonpharmacologic treatments for chronic low back pain is widely acknowledged. The compilation of many weakly effective, disparate therapies in the Guideline will do little to assist healthcare providers in making informed decisions, or for other purposes, including informing insurance coverage, quality of care evaluations, and medicolegal liability standards (4).
References
(1) Qaseem A, Wilt TJ, McLean RM, Forciea MA. Noninvasive treatments for acute, subacute and chronic low back pain: A clinical practice guideline from the American College of Physicians. Ann Intern Med 2017 doi:10.7326/M16-2367.
(2) Marcus DM. Is acupuncture for pain a placebo treatment? An examination of the evidence. The Rheumatologist 2010; 4: 1, 28-35.
(3) Chou R, Deyo R, Friedly J, Skelly A, Hashimoto R, Weimer M, Fu R, et al. Nonpharmacologic theerrapies for low back pain: A systematic review for an American College of Physicians clinical practice guideline. Ann Int Med 2017: 166 doi10.7326/M16-2459.
(4) Greenfield S. Clinical practice guidelines. Expanded use and misuse. JAMA 2017; 317: 594-5.
ABOUT GUIDELINE LOW BACK PAIN
Don't you believe that low back pain will have different treatments according to the cause can go since a muscular problem until osteoporotic fracture of the spine.
Treatment failure is a treatment issue, not a patient issue
The language we use to talk about whether and how our treatment has, or has not, helped our patient can shape our thinking. Many authors have written about how the language we use can change the way we think. No one has written more trenchantly about this issue than George Orwell in his novel, 1984, and in his essay, 'Politics and the English Language.'
The third recommendation from Qaseem, et al reads:
Recommendation 3: In patients with chronic low back pain who have had an inadequate response to nonpharmacologic therapy, clinicians and patients should consider pharmacologic treatment with nonsteroidal anti-inflammatory drugs as first-line therapy, or tramadol or duloxetine as second-line therapy. Clinicians should only consider opioids as an option in patients who have failed the aforementioned treatments and only if the potential benefits outweigh the risks for individual patients and after a discussion of known risks and realistic benefits with patients. (Grade: weak recommendation, moderate-quality evidence).
Right in the middle is the phrase, "in patients who have failed the aforementioned treatments." This phrase confuses the subject and predicate. The treatment has failed to help the patient. We should not blame the patient for "failing" to improve, but rather accept our responsibility for recommending, with good reason, a treatment which was intended to be helpful, but which has failed to improve our patient's condition. Our desire to linguistically offload responsibility to the patient is understandable, but pernicious, especially when we are considering whether to prescribe opioids for chronic pain. While the evidence for benefit is weak, there are some patients who do well with them, provided that we prescribe opioids responsibly, and continue to provide other forms of treatment and support for chronic back pain. If we label our patients as "failures," will we be less likely to consider prescribing opioids for them? I suspect that this habit of thinking of the patient having failed the treatment makes us less willing to consider opioids, even when other evidence might suggest a benefit. We should accept responsibility for our treatment failures, by clearly and consistently labeling the treatment, rather than the patient, as the failure.
Age Matters
The stakes of improperly treated back pain may be high in older adults. Each year back pain is experienced by nearly 17 million people 65 years and older. Age > 75 years and osteoporosis are ‘red flags’ that can indicate a serious underlying pathology such as a vertebral fracture. Older adults with chronic low back pain have more difficulty performing everyday tasks and more depressive symptoms. They are also at greater risk of adverse effects from some of the first line medications recommended in the guideline.
The use of NSAIDs in the elderly increases the risk of acute GI bleeds by a factor of 4. Although Proton Pump Inhibitors (PPIs) reduce this risk, PPIs are associated with increased bone loss, pneumonia and Clostridium Difficile in this population. Skeletal muscle relaxants are a ‘drug to avoid’ in the elderly (American Geriatrics Society 2015 Updated Beers Criteria) and have been associated with increased ED visits and hospitalization.
Our challenge as clinicians caring for these adults is to alleviate their pain without causing more harm, including greater functional decline. In the future, we hope that ACP will consider a focus in their guidelines that helps clinicians address the complexity of low back pain in aging adults.
Jeremy D. Whyman, MD
Palliative Medicine and Geriatrics Fellow
Brookdale Dept. of Geriatrics and Palliative Medicine
Icahn School of Medicine at Mount Sinai
Rosanne M. Leipzig MD, PhD
Gerald and May Ellen Ritter Professor
Vice Chair, Education
Brookdale Dept. of Geriatrics and Palliative Medicine
Icahn School of Medicine at Mount Sinai
Enthoven WTM Geuze J, Scheele J et al. Prevalence and “Red Flags” regarding specific causes of back pain in older adults presenting in general practice. Physical Therapy 2016:96(3):305-312.
Weiner DK, Haggerty CL., et al. How does low back pain impact physical function in independent, well-functioning older adults? Evidence from the Health ABC Cohort and implications for the future. Pain Med. 2003 Dec;4(4):311-20.
Pilotto, Alberto, Franceschi, Marilisa, et al. The risk of upper gastrointestinal bleeding in elderly users of aspirin and other non-steroidal antiinflammatory drugs: The role of gastroprotective drugs. Aging Clinical and Experimental Research December 2003, Volume 15, Issue 6, pp 494–499.
Kapadia A, Wynn Daisy, Salzman B, Potential Adverse Effects of Proton Pump Inhibitors in the Elderly. Clinical Geriatrics, July/August 2010.
Alvarez, Carlos A., et al. Association of skeletal muscle relaxers and antihistamines on mortality, hospitalizations, and emergency department visits in elderly patients: a nationwide retrospective cohort study. BMC Geriatrics 2015.
Reassessment of benefit from tramadol
We updated the Cochrane meta-analysis that the guideline’s recommendation is based on.(1) We completed the search for newer trials with a mix of methods. We subgrouped the trials based on whether they were registered prior to execution. Results are online at https://openMetaAnalysis.github.io/tramadol.
Our findings suggest several biases. While there are insufficient trials to test for publication bias with a funnel plot, we found significant differences in results between registered and unregistered trials with benefit confined to unregistered trials. Unregistered trials may lead to inflated results due to both publication bias and selective reporting bias.(2,3) Two of the four unregistered trials reported selecting patients after an open-label run-in phase - which may also inflate results.(4) In addition, the short duration of these trials (the longest lasting 13 weeks) does not seem relevant to the treatment of a chronic disease. Finally, heterogeneity of overall results was substantial at 90%.
Focusing on the subgroup of registered trials, we found no benefit from tramadol with 17% heterogeneity. Although the Guidelines describe the registered trial by Lee as showing benefit, this study is problematic.(5) According to the registration archives at ClinicalTrials.gov, the trial was registered after completion. The primary outcome according to ClinicalTrials.gov was “difference in pain intensity as measured on the Visual Analog Scale”. If this is interpreted as the mean change, that result is insignificant. If this interpreted as proportion responding, the authors omitted the randomized patients who dropped out. When we recalculate with an intention to treat analysis, the results are insignificant.
We encourage others to use the data from this review to help evolve the assessment of tramadol for chronic therapy of back pain.
References:
1.Chaparro LE, Furlan AD, Deshpande A, Mailis-Gagnon A, Atlas S, Turk DC. Opioids compared to placebo or other treatments for chronic low-back pain. Cochrane Database Syst Rev. 2013 Aug 27;(8):CD004959. PMID: 23983011
2.Kaplan RM, Irvin VL. Likelihood of Null Effects of Large NHLBI Clinical Trials Has Increased over Time. PLoS One. 2015 Aug 5;10(8):e0132382. PMID: 26244868
3.Chan AW, Hróbjartsson A, Haahr MT, Gøtzsche PC, Altman DG. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA. 2004 May 26;291(20):2457-65. PMID: 15161896
4.Prasad V, Berger VW. Hard-Wired Bias: How Even Double-Blind, Randomized Controlled Trials Can Be Skewed From the Start. Mayo Clin Proc. 2015 Sep;90(9):1171-5. PMID: 26277702
5.Lee JH, Lee CS; Ultracet ER Study Group.. A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of the extended-release tramadol hydrochloride/acetaminophen fixed-dose combination tablet for the treatment of chronic low back pain. Clin Ther. 2013 Nov;35(11):1830-40. PMID: 24183364.
Low Back Pain Guideline: What is the Next Step?
How does the primary care practitioner (PCP) use the information from the guideline when seeing a patient with LBP? Do they refer the patient for all recommended treatments? Do they refer the patient for each treatment one at a time until they land on one that helps? Do they provide a list of recommended treatments and allow the patient to choose?
None of these are efficient options, in our view. We think this illustrates the need in spine care for a designated professional who is specially trained, skilled and experienced in evidence-based clinical reasoning to determine the best course of action for each individual patient. A professional who can, based on the unique clinical features in each patient, provide differential diagnosis, manage the majority without the need for referral and, when necessary, provide guidance regarding other noninvasive or invasive options. As the guideline points out, medications are not recommended as a first-line approach, so this professional need not be a medical physician. This role can be played by specially-trained chiropractors and physical therapists. We refer to this professional as the Primary Spine Practitioner (PSP) (2).
An appropriately trained PSP can provide a clear, evidence-based explanation of the problem (the most important factor in patient satisfaction (3)) as well as evidence-based management that is tailored to each patient’s individual needs (2). The PSP can go beyond the general recommendations of a guideline to individualized care for each patient in a way that most PCPs are not well trained to do (4).
PSP services have been implemented in several environments. Preliminary data suggest that these services are efficient and provide good outcomes and patient satisfaction at low cost (5). Provider satisfaction, particularly for the PCP, is high. A formal training and certification program for PSPs has been developed at the University of Pittsburgh. We anticipate that wide implementation of PSP services, particularly within an integrated spine care pathway (5), will be of great benefit to PCPs and, most important, to patients and the health care system.
1. Atlas SJ. Management of Low Back Pain: Getting From Evidence-Based Recommendations to High-Value Care. Annals of internal medicine. 2017. doi: 10.7326/M17-0293. PubMed PMID: 28192792.
2. Murphy DR, Justice BD, Paskowski IC, Perle SM, Schneider MJ. The Establishment of a Primary Spine Care Practitioner and its Benefits to Health Care Reform in the United States. Chiropractic & manual therapies. 2011;19(1):17. PubMed PMID: 21777444.
3. Verbeek J, Sengers M, Riemens L, Haafkens J. Patient expectations of treatment for back pain: a systematic review of qualitative and quantitative studies. Spine. 2004;29(20):2309-17.
4. Goff I, Wise EM, Coady D, Walker D. Musculoskeletal training: are GP trainees exposed to the right case mix for independent practice? Clinical rheumatology. 2014. doi: 10.1007/s10067-014-2767-z. PubMed PMID: 25190366.
5. Paskowski I, Schneider M, Stevans J, Ventura JM, Justice BD. A hospital-based standardized spine care pathway: report of a multidisciplinary, evidence-based process. Journal of manipulative and physiological therapeutics. 2011;34(2):98-106. PubMed PMID: 21334541.
The authors declare no conflicts
Donald R. Murphy, DC, FRCC
Medical Director of Spine Program
Care New England Health System
Clinical Assistant Professor, Department of Family Medicine
Alpert Medical School of Brown University
600 Pawtucket Avenue
Pawtucket, RI 02860 USA
[email protected]
Michael J. Schneider, DC, PhD
Associate Professor, Department of Physical Therapy
University of Pittsburgh
Bridgeside Point 1
100 Technology Drive, Suite 210
Pittsburgh, PA 15219-3130 USA
[email protected]
Christopher G. Bise PT, MS, DPT, OCS
Assistant Professor, Department of Physical Therapy
University of Pittsburgh
School of Health and Rehabilitation Science
Bridgeside Point 1
100 Technology Drive, Suite 210
Pittsburgh, PA 15219-3130 USA
[email protected]
Brian Justice, DC
Medical Director Pathway Development and Spine Care
Excellus BlueCross BlueShield
165 Court Street, Rochester, NY 14647
[email protected]
Comment on ACP low back pain guideline
I believe that the authors should have mentioned the cardiovascular (CV) risk factors associated with NSAIDs.(2-4) In the same vein, on page 11, the paper reads, “COX-2–selective NSAIDs…are associated with lower risk for adverse effects than nonselective NSAIDs.” This statement is not necessarily true and adverse events are dependent upon many elements including the specific NSAID and risk factor.(4) Rofecoxib is one example of a COX-2 selective NSAID with intolerable side effects that was pulled from the market.(5)
The paper states under “Harms of Pharmacological Therapies,” that the harms were obtained from the reviews and admittedly there were no NSAID CV adverse events in the articles, but the authors raise potential harms of opioids under “Recommendation 3,” including addiction, abuse and overdose, and those adverse effects are also absent in the reviews. It’s important to be consistent and thus the CV risk factor for NSAIDs should have been added, along with a suggestion that clinicians evaluate their patient’s cardiovascular health prior to prescribing non-steroidal anti-inflammatories.
Furthermore, I have posited that the onset of pain may trigger the unconscious animal brain to believe there is a direct threat to survival.(6) In nature, injured animals get eaten. Under Recommendation 1, the authors suggest the clinician provides social support through educating the patient about the positive prognosis, course of healing and staying active—all while using patient-centered care. This is excellent advice and may help to disarm any potential threat in the patient’s mind, conscious or unconscious.
However, I wish the guideline had recommended consistent social support until the patient has recovered. There are a couple of reasons for this with the most important being to help prevent short-term low back pain from turning into long-term chronic pain. Individuals that catastrophize and/or are afraid to move their bodies may be vulnerable to this negative conversion and consistent support may help prevent it.(7-10) In addition, psycho-social elements can worsen one’s pain (11) and staying in touch with the patient may mitigate these negative influences.
Although some clinicians may not be accustomed to providing social support, my experience as a patient advocate has taught me that most people just need reassurance that everything is going to be fine, and that they are not alone in their recovery from back pain.
Mark Collen
Founder, PainExhibit.org
Editorial Board Member, Journal of Pain & Palliative Care Pharmacotherapy
The author declares no conflicts of interest.
References
(1) Qaseem A, Wilt TJ, McLean RM, Forciea MA. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of PhysiciansNoninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain. Ann Intern Med. 2017. [Epub ahead of print]
(2) McGettigan P, Henry D. Use of non-steroidal anti-inflammatory drugs that elevate cardiovascular risk: an examination of sales and essential medicines lists in low-, middle-, and high-income countries. PLoS Med. 2013;10:e1001388.
(3) Bello AE, Holt RJ. Cardiovascular risk with non-steroidal anti-inflammatory drugs: clinical implications. Drug Saf. 2014;37:897-902.
(4) Harirforoosh S, Asghar W, Jamali F. Adverse effects of nonsteroidal antiinflammatory drugs: an update of gastrointestinal, cardiovascular and renal complications. J Pharm Pharm Sci. 2014;16:821-847.
(5) Berenson A, Gardiner H, Meier B, Pollack A. Despite warnings, drug giant took long path to Vioxx recall. New York Times. November 14, 2004. Available at: http://www.nytimes.com/2004/11/14/business/despite-warnings-drug-giant-took-long-path-to-vioxx-recall.html? Accessed February 21, 2017.
(6) Collen M. Pain and treatment from a human primate perspective. J Pain Palliat Care Pharmacother. 2014;28:152-157.
(7) Quartana PJ, Campbell CM, Edwards RR. Pain catastrophizing: a critical review. Expert Rev Neurother. 2009;9:745-758.
(8) Smeets RJ, Vlaeyen JW, Kester AD, Knottnerus JA. Reduction of pain catastrophizing mediates the outcome of both physical and cognitive-behavioral treatment in chronic low back pain. J Pain. 2006;7:261-271.
(9) O’Sullivan P. Diagnosis and classification of chronic low back pain disorders: maladaptive movement and motor control impairments as underlying mechanism. Man Ther. 2005;10:242-255.
(10) Leeuw M, Goossens ME, Linton SJ, Crombez G, Boersma K, Vlaeyen JW. The fear-avoidance model of musculoskeletal pain: current state of scientific evidence. J Behav Med. 2007;30:77-94.
(11) Hoogendoorn WE, van Poppel MN, Bongers PM, Koes BW, Bouter LM. Systematic review of psychosocial factors at work and private life as risk factors for back pain. Spine. 2000;25:2114-2125.
Acupuncture and low-back pain: an international bazar
First, the correct term is “Complementary and Alternative Practices” (CAP): medicine should be based on evidence. Adding “therapies” to practices which enduringly failed to show evidence of relevant effects creates an oxymoron.(2) For low back pain, endpoints are a decrease in pharmacological treatment, an increase in the odds of being at work, improved functional limitations or quality of life …
Second, the recommendation ignored several old robust trials published in core clinical journals showing effectiveness of Cognitive Behavioral Therapies.(e.g. 3,4) The trial cited as reference 121 was prolonged, confirming improvements in pain and functional limitations at 26 weeks.(5)
Third, in England, the National Institute for Health and Care Excellence specifically recommended acupuncture NOT be used for managing low back pain as evidence is lacking.(https://www.nice.org.uk/guidance/ng59) In Australia, Friends of Science in Medicine warned “There is already enough evidence to confidently conclude that acupuncture doesn’t work. It is merely a theatrical placebo based on pre-scientific myths”(www.scienceinmedicine.org.au/images/pdf/acupuncturereview.pdf) and showed advertising claims are grossly misleading lay people.(http://www.scienceinmedicine.org.au/images/pdf/ukasaletter.pdf)
Patients need explanations and reassurance to promote autonomy, not to be given faith in weird practices. Several skills in the doctor-patient encounter are pivotal (take time, remove barriers, let the patient explain…), CAP cannot replace them, they only strengthen medical arrogance. Voltaire at his time (1694-1778) stated "The art of medicine consists in amusing the patient while nature cures the disease." In 2017 AD, why amusing patients with weird practices from BC and non-existing meridians? Last, acupuncture was excluded from the Imperial Medical Institute by a decree of the Emperor of China in 1822, being regarded as superstitious and irrational.
1 Qaseem A, Wilt TJ1, McLean RM et al. Noninvasive treatments for acute, subacute, and chronic low back pain: A clinical practice guideline from the American College of Physicians. Ann Intern Med 2017. Online Feb 14. doi: 10.7326/M16-2367.
2 Braillon A. Placebo and chronic low back pain: Too much in way of expectations, too little in terms of data. Pain 2017;158:535-536.
3 Cherkin DC, Sherman KJ, Balderson BH et al. Effect of mindfulness-based stress reduction vs cognitive behavioral therapy or usual care on back pain and functional limitations in adults with chronic low back pain: A randomized clinical trial. JAMA 2016;315:1240-9.
4 Lamb SE, Mistry D, Lall R et al. Group cognitive behavioural treatment for low-back pain in primary care: a randomised controlled trial and cost-effectiveness analysis. Lancet 2010;375:916-23
5 Cherkin DC, Sherman KJ, Balderson BH et al. Two-year follow-up of a randomized clinical trial
of mindfulness-based stress reduction vs cognitive behavioral therapy or usual care for chronic low back pain. JAMA 2017:317:642-3.
Missing first step
This is a nice review of treatments but it is missing an important first step! One should first make a diagnosis. Back pain is a symptom, not specific condition. Compression fractures, metastatic cancer, facet joint conditions, spinal stenosis can all give acute or chronic back pain and the treatment needs to be guided by the diagnosis.