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Research Review By Dr. Demetry Assimakopoulos©

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Date Posted:

November 2017

Study Title:

Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline from the American College of Physicians

Authors:

Qaseem A, Wilt TJ, McLean RM, et al.

Author's Affiliations:

American College of Physicians, Philadelphia, PA; Minneapolis VA Medical Center, Minneapolis, MN; Yale School of Medicine, New Haven, CT, USA.

Publication Information:

Annals of Internal Medicine 2017; 166: 514-530. doi:10.7326/M16-2367

Background Information:

Low back pain (LBP) is a common affliction, affecting approximately one-quarter of American adults for at least one day in any three-month period (1). Above-and-beyond the human aspects of being in pain, LBP is also associated both directly and indirectly with elevated healthcare costs (2).

The purpose of this widely-disseminated publication was to provide evidence-based treatment guidelines based on the efficacy, comparative effectiveness and safety of non-invasive pharmacologic and non-pharmacologic treatments for acute (< 4 weeks), subacute (4-12 weeks) and chronic (> 12 weeks) low back pain (with or without radiculopathy) in primary care.

Summary:

Pharmaceutical Interventions:

Acute or Subacute Low Back Pain
  • Acetaminophen: there was low-quality evidence demonstrating no difference between acetaminophen and placebo for pain intensity and/or function over 4 weeks. A similar result was shown between acetaminophen and NSAIDS for pain intensity or likelihood of experiencing global improvement after 3 weeks.
  • NSAIDs: there exists moderate quality evidence demonstrating that NSAIDs are associated with small improvements in pain intensity compared to placebo. Conversely, multiple RCTs showed no difference in the likelihood of achieving pain relief with NSAIDs compared to placebo. Moderate quality evidence showed no difference in pain relief when comparing NSAIDs head-to-head. Low quality evidence also demonstrated no difference in pain relief when comparing COX-2-selective NSAIDs and traditional NSAIDs.
  • Skeletal Muscle Relaxants (SMRs): These provided short-term pain relief compared to placebo after 2-4 and 5-7 days. However, low quality evidence showed no difference when comparing SMR’s head-to-head. There was low quality and inconsistent evidence when adding SMR’s and NSAIDs together, particularly when compared to NSAIDs alone.
  • Systemic Corticosteroids: there exists low quality evidence demonstrating no difference in pain and/or function for intramuscular methylprednisolone, or 5 days of prednisolone administration compared to placebo.
Chronic Low Back Pain (CLBP)
  • NSAIDs: Moderate-quality evidence showed small-to-moderate pain improvements compared to placebo, and low-quality evidence demonstrates ‘no’ to ‘small’ functional improvement. There’s no difference between individual NSAIDs for CLBP.
  • Opioids: There is moderate-quality evidence showing strong opioids (tapentadol, morphine, hydromorphone and oxymorphine) are associated with a small (1/10!), short-term improvement in pain scores and function compared to placebo. Buprenorphine patches (weak opioid patch placed on skin for 7 days), is associated with short-term pain improvement of CLBP, which corresponded to a pain rating change of < 1 out of a possible 10. Moderate-quality evidence showed no difference in analgesic effect when comparing different long-acting opioids (i.e. oxycodone, hydromorphone contin, codeine contin, etc.). There exists no clear difference in pain relief between long- and short-acting opioids. Tramadol (weak opioid; has centrally acting properties) achieved moderate short-term pain relief and small improvement in function in comparison to placebo.
  • Benzodiazepines: Tetrazepam demonstrated a pain improvement at 5-7 days and 10-14 days compared to placebo.
  • Antidepressants: (NOTE: there are many classes of antidepressants. The ones typically used for pain are tricyclic antidepressants (TCAs), selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs)).. No difference exists in pain relieving capabilities between TCAs or SSRIs vs. placebo. There was also a general lack of functional capacity change when prescribing antidepressants in CLBP patients. Duloxetine (Tradename: Cymbalta; an SNRI) is associated with a small pain intensity and functional improvements, compared to placebo (NOTE: Please understand that duloxetine has 5 indications in Canada: fibromyalgia/widespread pain, depression, chronic pain, neuropathic pain and low back pain. The effect of this medication may depend on the individual, and the reason for prescription).
  • Other: There was insufficient data to determine the effect of acetaminophen, corticosteroids or anti-seizure medications (aka adjuvant medications; examples include Lyrica/Pregabalin or Gabapentin/Neurontin) on chronic low back pain.
Acute/Sub-Acute Radicular Low Back Pain
  • Benzodiazepines: A comparative analysis of diazepam and placebo medication showed there was no difference in function, analgesia, return to work or likelihood of surgery during the 1-week – 1-year time periods in patients with acute or subacute radicular pain. Interestingly, diazepam resulted in a lower likelihood of pain improvement at 1 week, compared to placebo.
  • Corticosteroids: Evidence demonstrated no differences in pain between systemic corticosteroids and placebo, and a ‘no’ to ‘small’ effect in function.
Harms Associated with Pharmacotherapy

Harms were generally poorly reported. NSAIDs trials reported increased adverse effects compared with placebo and acetaminophen. However, the use of COX-2-selective NSAIDs decreased the risk of adverse effects, when compared to traditional NSAIDs. Adverse effects from opioid consumption include increased nausea, dizziness, constipation, vomiting, somnolence (drowsiness) and dry mouth. SMRs were associated with increased risk for any adverse event and CNS adverse events (primarily sedation) compared to placebo. The use of antidepressants increased the risk for any adverse event, compared to placebo. Finally, benzodiazepines were primarily associated with somnolence, fatigue and light-headedness.

Non-Pharmacologic Therapies

Acute or Subacute Low Back Pain
  • Exercise: there was no difference between exercise therapy and usual care (i.e. care from a general practitioner [GP], including advice against bed rest and pharmacotherapy) for pain and function in patients with acute or subacute back pain. A total of 20 RCTs comparing different exercise protocols head-to-head failed to demonstrate any difference in efficacy.
  • Acupuncture: There is low quality evidence showing acupuncture offers a small decrease in pain intensity compared to non-penetrating needles, but is without a clear effect on function. Compared to NSAIDs, acupuncture can slightly increase the likelihood of overall improvement.
  • Massage: The literature demonstrated that massage provided a moderate improvement in pain and function in the short-term (1 week), compared to sham for subacute back pain. A separate study showed no difference in pain and function after 5 weeks of massage care (exact dose unclear). Other studies have demonstrated that massage provided short-term pain and functional improvements compared to other interventions for patients with subacute back pain; however, the effects were small. Low-quality evidence has concluded that massage in combination with another intervention is superior to the “other intervention” alone in the short-term for subacute and chronic low back pain patients.
  • Spinal Manipulation (SMT): One low quality study demonstrated that SMT was associated with a small effect on function compared to sham. However, the evidence was insufficient to determine if it has any effect on pain. Other studies have shown no difference in pain relief after 1 week of SMT treatment compared to an inert treatment (i.e. Educational booklet, detuned ultrasound, detuned or actual short-wave diathermy, bed rest). A longer trial showed better longer-term pain relief after 3 months of SMT. However, function did not differ between SMT and inert treatment cohorts at 1 week or 3 months. Another moderate-quality study showed no difference between SMT and other active interventions for pain relief at 1 week-1 year of treatments (REVIEWER’S NOTE: Keep in mind, that this is a good finding. It implies that the patients got better, regardless of the intervention). Low-quality evidence has demonstrated that a combination of SMT and exercise, or advice slightly improved function after 1 week of treatment compared to groups who underwent exercise or advice alone. However, these effects were not observed at 1 or 3-month follow-up.
  • Superficial Heat: Heat wrapping can moderately improve pain (at 5 days) and disability (at 4 days) compared to placebo. A combination of heat and exercise can provide greater pain relief and improved Roland-Morris Disability Questionnaire (RDQ) scores at 7 days, compared to exercise alone in acute LBP patients. It can also provide more effective pain relief and improved RDQ scores compared to acetaminophen or ibuprofen after 1-2 days. A separate study showed no clear difference between heat and exercise for pain relief or function.
  • Low Level Laser Therapy (LLLT): Low quality evidence demonstrated that combining LLLT and NSAIDs decreased pain intensity and resulted in a moderate improvement in function (ODI) compared to sham laser plus NSAIDs in patients with acute or subacute low back pain.
  • Lumbar Supports: It has been shown that there is no difference in pain or function when adding lumbar supports to an educational program. A similar result was found when comparing lumbar supports to active interventions.
  • Other Therapies: There is insufficient evidence to determine the effect of TENS, electrical muscle stimulation, inferential therapy, short wave diathermy, traction, superficial cold, motor control exercises (MCE), Pilates, tai chi, yoga, psychological therapies, multidisciplinary rehabilitation, ultrasound and taping for acute and subacute LBP.
Chronic Low Back Pain
  • Exercise: Moderate-quality evidence has demonstrated a small improvement in pain relief and function, compared to no exercise. Similar studies have also shown that, compared with usual care, exercise resulted in small improvements in pain intensity and function at the end of treatment, with small long-term effects. Moderate-quality evidence demonstrated no clear difference between the different exercise regimens in greater than 20 head-to-head RCTs in patients with chronic LBP. (REVIEWER’S NOTE: this last point is an important finding. There have been many debates about the optimal way to prescribe rehabilitation exercises. It is my opinion that different exercise approaches are suited towards different people, and that exercise selection should be made for the needs and preferences of your individual patient).
  • Motor Control Exercise (MCE): This mode of exercise focuses on restoring coordination, control and strength of the muscles that control the spine. Low-quality evidence demonstrated that MCE moderately decreased pain scores and slightly improved function in the short- to long-term follow-up with a minimal intervention. Similar studies have shown that MCE resulted in small improvements in pain intensity at short- (≥ 6 weeks to < 4 months) and intermediate-term (≥ 4 to ≤ 8 months) follow-up compared to general exercise. Interestingly, the improvements were small and no longer significant at long-term follow-up. MCE also resulted in small functional improvements in the short and long-term. Another study demonstrated moderate improvement in pain intensity and function compared to multi-modal physical therapy at intermediate follow-up. Low-quality evidence showed no clear difference in pain with a combination of MCE plus exercise vs. exercise alone.
  • Pilates: Low-quality evidence has demonstrated that Pilates offers small or no clear effects on pain and no clear effects on function compared to usual care, plus physical activity. Other studies have shown no clear differences between Pilates and other types of exercise for pain and function.
  • Tai Chi: Low-quality evidence showed that tai chi provided moderate pain improvement compared with wait list controls. An additional study showed a small improvement in function. Moderate-quality evidence showed tai chi modestly decreased pain intensity at 3-6 months compared with backward walking or jogging, but not when compared to swimming.
  • Yoga: Low-quality evidence demonstrated that Iyengar yoga resulted in moderately lower pain scores and improved function compared with usual care after 24 weeks. Low-quality evidence showed that yoga resulted in a small decrease in pain intensity compared to exercise. Similar studies have also shown that yoga provided a small decrease in pain intensity in the short-term (≤12 weeks) but not long term (about 1 year), and a small improvement in short- and long-term function, in comparison to education.
  • Psychological Treatment: Studies which have measured the effect of mindfulness-based stress reduction showed small improvements in CLBP pain and function. Similar studies showed moderate improvements in pain and function from progressive relaxation interventions. Operant therapy and cognitive behavioural therapies have shown respectively small and moderate effects on CLBP.
  • Multidisciplinary Rehabilitation: These interventions can moderately reduce short-term (< 3 months) and slightly reduce long-term pain intensity and disability compared with usual care. There was unfortunately no difference in return to work in these groups. Low-quality evidence showed that multidisciplinary rehabilitation was associated with moderately lower short-term pain intensity and slightly lower disability than no rehabilitation. Additionally, moderate quality evidence demonstrated that multidisciplinary rehabilitation was associated with slightly improved short-term pain intensity and disability, and moderately improved long-term pain intensity and function compared to physical therapy. This last study also showed that there was a greater likelihood of patients returning to work, in comparison to cohorts who did not undergo multidisciplinary rehabilitation.
  • Acupuncture: Low-quality evidence has demonstrated that acupuncture can offer moderate improvements in pain relief immediately after treatment, and up to 12 weeks later, compared to sham acupuncture. Unfortunately, these analgesic effects tend to manifest without an improvement in physical function. Moderate-quality evidence showed that acupuncture lowered pain intensity and improved function compared to no acupuncture at the end of treatment. Other studies have shown small improvements in pain relief and function compared to medication alone (NSAIDs, muscle relaxants or analgesics).
  • Massage: The evidence has demonstrated no difference in pain intensity between foot reflexology and usual care for CLBP. However, other studies showed that massage offers short-term, small effects in pain relief and function, compared with other interventions (manipulation, exercise therapy, relaxation therapy, acupuncture, physiotherapy or TENS) for patients with subacute to CLBP. Low-quality evidence showed that combining massage and “other interventions” (i.e. exercise, exercise and education, or usual care) was superior to “other interventions” alone for short-term pain in patients with subacute-to-chronic low back pain.
  • Spinal Manipulation (SMT): Low-quality evidence showed no difference in pain with SMT compared to sham SMT at 1 month. Other studies have provided low-quality evidence that SMT slightly improved pain compared with an inert treatment. Moderate-quality evidence showed no clear differences in pain or function compared with other active treatments. Additionally, low-quality evidence revealed that a combination of SMT with other active care treatment offered greater pain relief and improved function at 1, 3 and 12 months, compared with other treatments alone.
  • Ultrasound and TENS: Low-quality evidence exists for the use of these two therapies in the short or long term.
  • LLLT: Evidence has showed that LLLT slightly improved pain and function compared to sham laser.
  • Taping: The evidence for this is all-together low in quality. Studies have shown no difference between Kinesio taping and sham taping for back-specific function after 5 or 12 weeks – the interventions’ effects on pain were inconsistent. Low-quality evidence demonstrated no difference between Kinesio taping and exercise for pain or function.
  • Other Therapies: Evidence was insufficient to infer the effects of electrical muscle stimulation, interferential therapy, short-wave diathermy, traction or superficial heat/cold for CLBP.
Chronic Radicular Low Back Pain
  • The evidence demonstrated small improvements in pain and function when applying exercise interventions for chronic radicular LBP. The evidence for traction in patients with chronic radicular LBP is largely lower in quality. Generally, the studies have demonstrated no clear difference between traction and other active treatments. Additionally, similar studies showed no difference between traction in addition to physiotherapy, and versus physiotherapy alone, in individuals with LBP with or without radiculopathy.
Harms Associated with Non-Pharmacologic Therapies:

Generally, these were poorly reported throughout the literature, so there was not a lot of evidence on which to base recommendations. However, the available evidence showed no increase in serious adverse effects.

Clinical Application & Conclusions:

The authors performed a systematic review of the evidence for pharmacological and conservative treatments for acute, subacute and chronic low back pain, with or without radiculopathy. Meta-analyses were performed when appropriate. By assessing the body of evidence as a whole, they were able to produce the following three high-level recommendations:

Recommendation 1: ”Given that most patients with acute or sub-acute low back pain improve over time regardless of treatment, clinicians and patients should select non-pharmacologic 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 NSAIDs or muscle relaxants (moderate-quality evidence). Grade: Strong Recommendation.” The authors then add that the prognosis for acute low back pain with or without sciatica is generally favourable, with a high likelihood for substantial improvement in the first month (3, 4). Clinicians should also tell patients that they should remain active as tolerated, and provide information regarding effective self-care options.

Recommendation 2: ”For patients with CLBP, clinicians and patients should initially select non-pharmacologic treatment with exercise, multidisciplinary rehabilitation, acupuncture, mindfulness (moderate-quality evidence), tai chi, yoga, motor control exercise, progressive rehabilitation, relaxation, biofeedback, LLLT, operant therapy, CBT or spinal manipulation (low-quality evidence). Grade: Strong Recommendation.” They add that non-pharmacologic therapies are first-line options in the treatment of patients with CLBP, due to the notion that fewer harms are associated with these therapies, compared to pharmacological treatments.

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.”

Reviewer’s comments: Why is this article important?

This article advocates for the use of conservative treatments (including spinal manipulation) as first-line therapies for acute, subacute and chronic low back pain. This will hopefully improve the relationship between standard medical and allied healthcare professionals, and ultimately benefit patients.

Additionally, the article provides an extensive review of the efficacy of pharmaceutical interventions for back pain. There are multiple reasons why this is important to allied healthcare providers who have no or limited ability to prescribe medication. Understanding the different pharmaceutical classes and the multiple medications that are placed into these classes, will enable better inter-professional communication. Thus, if your treatments fail to provide sufficient analgesia and/or functional improvement, and you believe your patient is in need of pharmaceutical treatment, you will know what to ask for when communicating with the patient’s physician. This will enable true inter-disciplinary care.

Study Methods:

The authors utilized the American College of Physicians Guideline Grading System to grade the quality of evidence, which was adopted from the Grading of Recommendations Assessment, Development and Evaluation (GRADE) workgroup.

A systematic review of the evidence was performed. The authors searched many databases for English language studies published between January, 2008 and November, 2016. Meta-analyses and risk of bias assessment was performed when appropriate. The included subjects were adults (≥ 18 yoa), with acute, subacute or chronic non-radicular LBP, radicular LBP or symptomatic spinal stenosis. The evaluation included pharmacologic, non-pharmacologic and multi-disciplinary therapies. The magnitude of therapeutic effect (small, moderate, large) was graded as follows (5, 6):
  • Small: mean between-group difference after treatment of 5-10 points on a VAS (0-100), a 0.5-1.0 point different on a numerical rating scale (0-10), or a standardized mean difference of 0.2-0.5.
  • Moderate: Mean between-group difference of > 10-20 points on a VAS (0-100), > 1-2 points on a numerical rating scale (0-10), or a standardized mean difference between 0.5-0.8.
  • No large effect sizes were found
An intervention’s effect on function was graded as follows:
  • Small: mean between-group difference of 5-10 points on the Oswestry Disability Index (ODI) or 1-2 points on the Roland-Morris Disability Questionnaire (RDQ).
  • Moderate: a mean between-group difference of 10-20 ODI points, or 2-5 points on the RDQ, or a standardized mean difference of greater than 0.5-0.8.
  • No large effect sizes were found.

Study Strengths / Weaknesses:

Weaknesses:
  • Many of the included trials, evaluating both pharmaceutical and conservative interventions, did not take the presence of different pain modulators such as mood and sleep status into account as potential covariates. The presence of mood or sleep disorders can decrease the likelihood of improvement with any intervention. It is imperative, as has been documented in the literature, that exclusion criteria be expanded, to also cover overt mood and sleep disorders. This may enable stakeholders to identify positive responders to therapy, and allow treating clinicians to understand the mechanisms behind a lack of improvement with certain interventions.
  • The authors only focused on 2 variables: pain and function. No mention was made of other measurements, such as pain self-efficacy, pain acceptance, catastrophization, kinesiophobia, mood or self-perception of disease severity. These other variables are important in the creation and severity of chronic pain and disability, and are also important in the individual usage of healthcare services.
Strengths:
    • Meta-analyses were performed when appropriate.
    • There were many changes to the 2007 ACP guidelines that the authors highlighted. The 2007 guidelines concluded that acetaminophen was effective for acute low back pain. This 2017 ACP guideline update included new evidence that showed no difference in effectiveness between acetaminophen and placebo (low-quality evidence). Also, contrary to the 2007 review, this 2017 ACP guideline showed that TCAs were not effective for treatment of chronic LBP compared to placebo. This guideline also showed that superficial heat is effective for acute and subacute LBP (moderate-quality evidence). They also included new treatment modalities including duloxetine, anti-seizure medication, mindfulness, motor control exercise (MCE), taping and tai chi. The notion that multiple opinions changed, indicates that a true effort was made to synthesize the most current evidence for this review. That should be applauded.

Additional References:

    1. Deyo RA, Mirza SK, Martin BI. Back pain prevalence and visit rates: estimates from U.S. national surveys, 2002. Spine 2006; 31: 2724-727.
    2. Andersson GB. Epidemiological features of chronic low-back pain. Lancet 1999; 354: 581-585.
    3. Pengel LH, Herbert RD, Maher CG, Refshauge KM. Acute low back pain: systematic review of its prognosis. BMJ 2003; 327:323.
    4. Jin M, Chen J. Acupuncture treatment for 40 cases of acute lumbar sprain [in Chinese]. Journal of Gansu College of Traditional Chinese Medicine 2008; 2006: 49-50.
    5. Chou R, Huffman LH; American Pain Society. Medications for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Ann Intern Med 2007; 147: 505-514.
    6. Chou R, Huffman LH; American Pain Society. Nonpharmacologic therapies for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Ann Intern Med 2007; 147: 492-504.

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