Clinical practice guidelines are systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.
Clinical practice guidelines define the role of specific diagnostic and treatment modalities in the diagnosis and management of patients.
Clinical practice guideline recommendations are based on evidence from rigorous systematic reviews and synthesis of the published medical literature.
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Pain is a huge problem in America. Of the 238 million adults in America, approximately half (116 million) suffer from chronic pain (1, 2, 3). The most common location for chronic pain is the low back, accounting for nearly one third of all reported regions (4). The economic loss attributed to chronic low back pain (healthcare costs and lost wages) is literally hundreds of billions of dollars annually (3).
Evidence for the treatment of low back pain has continued to evolve, especially in the last decade. A central theme in the evolution of Low Back Pain Clinical Practice Guidelines is a trend away from pharmacology and an emphasis on non-drug approaches.
This trend away from pharmacology and towards non-drug approaches is especially true with respects to the use of opiate drugs. For a number of reasons, opiate pharmacology has become very popular in the management of back pain (5). However, opioids for the treatment of back (and other) pain syndromes are very problematic. Headlines such as these are commonplace in the lay press (6, 7, 8, 9):
“They’re the Most Powerful Painkillers Ever Invented. And They’re Creating the Worst Addiction Crisis America Has Ever Seen”
Time; June 15, 2015
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“Opioid Rising”
“The Centers for Disease Control and Prevention Now Considers Opioid Drug Abuse to be a Full-Fledged Epidemic”
RandReview; November/December 2015
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“Doctors Told Not to Prescribe Opiates for Chronic Pain; Centers for Disease Control Says Risks Far Outweigh Benefits”
USA Today; March 16, 2016
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“Opioid-Related Fatalities Reach New Peaks”
Wall Street Journal; January 8, 2017
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The October 2007 issue of the journal Annals of Internal Medicine published the comprehensive and authoritative (10, 11):
Clinical Guidelines for the Diagnosis and Treatment of Low Back Pain
An extensive panel of qualified experts constructed these clinical practice guidelines. These experts performed a review of the literature on the topic and then graded the validity of each study. The literature search for this guideline included studies from MEDLINE (1966 through November 2006), the Cochrane Database of Systematic Reviews, the Cochrane Central Register of Controlled Trials, and EMBASE. This project was commissioned as a joint effort of the American College of Physicians and the American Pain Society. The results of their efforts are summarized in two separate articles. The first article is (10):
Diagnosis and Treatment of Low Back Pain:
A Joint Clinical Practice Guideline from the
American College of Physicians and the American Pain Society
This article has 131 references, resulting is seven recommendations, as follows:
Recommendation 1:
Clinicians should conduct a focused history and physical examination to help place patients with low back pain into 1 of 3 broad categories:
1)Nonspecific low back pain
2)Back pain potentially associated with radiculopathy or spinal stenosis
3)Back pain potentially associated with another specific spinal cause
Recommendation 2:
Clinicians should not routinely obtain imaging or other diagnostic tests in patients with nonspecific low back pain.
Recommendation 3:
Clinicians should perform diagnostic imaging and testing for patients with low back pain when severe or progressive neurologic deficits are present or when serious underlying conditions are suspected on the basis of history and physical examination.
Recommendation 4:
Clinicians should evaluate patients with persistent low back pain and signs or symptoms of radiculopathy or spinal stenosis with magnetic resonance imaging (preferred) or computed tomography only if they are potential candidates for surgery or epidural steroid injection (for suspected radiculopathy).
Recommendation 5:
Clinicians should provide patients with evidence-based information on low back pain with regard to their expected course, advise patients to remain active, and provide information about effective self-care options.
Recommendation 6:
For patients with low back pain, clinicians should consider the use of medications with proven benefits in conjunction with back care information and self-care. For most patients, first-line medication options are acetaminophen or non-steroidal anti-inflammatory drugs.
Recommendation 7:
For patients who do not improve with self-care options, clinicians should consider the addition of non-pharmacologic therapy with proven benefitsófor acute low back pain, spinal manipulation.
For chronic or subacute low back pain, intensive interdisciplinary rehabilitation, exercise therapy, acupuncture, massage therapy, spinal manipulation, yoga, cognitive-behavioral therapy, or progressive relaxation.
Important for this discussion is that these 2007 Guidelines for the Diagnosis and Treatment of Low Back Pain advocate the use of acetaminophen as a first-line medication for the management of an episode of low back pain (Recommendation 6). This recommendation will change as new evidence is presented and incorporated into the evolution of Low Back Pain Guidelines.
Also, this publication notes that acceptable non-pharmacologic options for acute, subacute, and chronic low back pain includes spinal manipulation. In fact, in this document, spinal manipulation is the only non-drug treatment recommendation for acute low back pain. This article notes:
For acute low back pain (duration 4 weeks), spinal manipulation administered by providers with appropriate training is recommended.
“For chronic low back pain, moderately effective non-pharmacologic therapies include acupuncture, exercise therapy, massage therapy, yoga, cognitive-behavioral therapy or progressive relaxation, spinal manipulation, and intensive interdisciplinary rehabilitation.”
At the end of this article, the authors make the following disclaimer:
“Note: Clinical practice guidelines are ‘guides’ only and may not apply to all patients and all clinical situations. Thus, they are not intended to override clinicians’ judgment.”
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The second article was also in the October 2007 issue of the journal Annals of Internal Medicine. At the time (a decade ago, 2007), it was the most comprehensive review of the literature concerning non-drug therapies used in the treatment of low back pain. It was titled (11):
Non-pharmacologic Therapies for Acute and Chronic Low Back Pain:
A Review of the Evidence for the American Pain Society
and the American College of Physicians Clinical Practice Guideline
This article has 188 references. It defines spinal manipulation as:
“Manual therapy in which loads are applied to the spine using short- or long-lever methods. High-velocity thrusts are applied to a spinal joint beyond its restricted range of movement.”
Spinal mobilization is defined as:
“Low-velocity, passive movements within or at the limit of joint range.”
These authors note that there are many non-pharmacologic therapies available for treatment of low back pain. They therefore assessed the benefits and harms of acupuncture, back schools, psychological therapies, exercise therapy, functional restoration, interdisciplinary therapy, massage, physical therapies (interferential therapy, low-level laser therapy, lumbar supports, shortwave diathermy, superficial heat, traction, transcutaneous electrical nerve stimulation, and ultrasonography), spinal manipulation, and yoga for acute or chronic low back pain (with or without leg pain). These authors note:
There is “good evidence that cognitive-behavioral therapy, exercise, spinal manipulation, and interdisciplinary rehabilitation are all moderately effective for chronic or subacute (4 weeks’ duration) low back pain.”
There is “fair evidence that acupuncture, massage, yoga, and functional restoration are also effective for chronic low back pain.”
“For acute low back pain (4 weeks’ duration), the only non-pharmacologic therapies with evidence of efficacy are superficial heat and spinal manipulation.”
In this review, the only non-drug treatment that has proven evidence to benefit acute, subacute, and chronic back pain is spinal manipulation.
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The Council on Chiropractic Guidelines and Practice Parameters (CCGPP) have been in continuous development since 1995. The most recent update appeared in the Journal of Manipulative and Physiological Therapeutics in 2006, and is titled (12):
Clinical Practice Guideline:
Chiropractic Care for Low Back Pain
This publication is the most recent update of the best practice recommendations for chiropractic management of low back pain; the update included 80 references. The participants continue to perform a systemic review of published articles on the topic, as well as entertain input from multidisciplinary experts who represent a broad sampling of jurisdictions and practice experience related to low back pain management. The panel used the RAND-UCLA methodology to reach a formal, robust consensus position. The process and review is comprehensive and detailed. The conclusion of the process is:
“The evidence supports that doctors of chiropractic are well suited to diagnose, treat, co-manage, and manage the treatment of patients with low back pain disorders.”
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In February 2017 the European Journal of Pain published a study titled (13):
Clinical Practice Guidelines for the
Noninvasive Management of Low Back Pain:
A Systematic Review by the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration
These authors performed an extensive search of published Low Back Pain Guidelines published between 2005 and 2014. Their conclusions include:
“Most high-quality guidelines target the noninvasive management of nonspecific low back pain and recommend education, staying active/exercise, manual therapy, and paracetamol [acetaminophen] or NSAIDs as first-line treatments.”
“However, the endorsement of paracetamol [acetaminophen] for acute low back pain is challenged by a recent high-quality randomized controlled trial and systematic review; therefore, guidelines need updating.”
In contrast to the Low Back Pain Guidelines published in 2007 (10), these Guidelines do NOT advocate the use of acetaminophen for the treatment of low back pain.
It is also noteworthy that these Guidelines do advocate manual therapy for low back pain. They define manual therapy as the application of either manipulation or mobilization. They state:
“Manual therapy, including spinal manipulation or mobilizations.”
“Recommended treatment frequency/duration was a maximum of nine sessions over up to 12 weeks.” [for acute low back pain]
Acetaminophen (paracetamol) is a pain reliever found in many products. In the United States, the best-known brand name for acetaminophen is Tylenol. The use of acetaminophen has fallen into disfavor in the treatment of low back pain as a consequence of a number of published studies, including the following:
In 2014, the journal Lancet published a study titled (14)
Efficacy of Paracetamol for Acute Low-Back Pain:
A Double-Blind, Randomised Controlled Trial
This is a multicenter, double-blind, randomized, placebo controlled trial involving patients with acute low-back pain, followed for 3 months. These authors note:
Guidelines for acute low-back pain universally recommend paracetamol as the first-line analgesic; “No direct evidence supports this universal recommendation.”
“Although guidelines endorse paracetamol for acute low-back pain, this recommendation is based on scarce evidence.”
“Neither regular nor as-needed paracetamol improved recovery time or pain intensity, disability, function, global change in symptoms, sleep, or quality of life at any stage during a 3-month follow up.”
The results of this study “suggest that simple analgesics such as paracetamol might not be of primary importance in the management of acute low-back pain, and the universal recommendation in clinical practice guidelines to provide paracetamol as a first-line treatment should be reconsidered.”
“Our results convey the need to reconsider the universal endorsement of paracetamol in clinical practice guidelines as first-line care for low-back pain.”
The second study was published in 2015 in the British Medical Journal, and titled (15):
Efficacy and Safety of Paracetamol for
Spinal Pain and Osteoarthritis:
Systematic Review and Meta-Analysis of
Randomised Placebo Controlled Trials
The objective of this study was to investigate the efficacy and safety of paracetamol (acetaminophen) in the management of spinal pain and osteoarthritis of the hip or knee. The authors performed a systematic review and meta-analysis of randomized controlled trials found in multiple medical databases. Their analysis is extremely complicated and detailed. The evidence presented is considered to be of “High Quality.” These authors note:
Our results confirm the “conclusion that paracetamol does not deliver a clinically important benefit for spinal pain and osteoarthritis.”
“There was ‘high quality’ evidence that paracetamol is ineffective for reducing pain intensity and disability or improving quality of life in the short term in people with low back pain.”
“Paracetamol is ineffective in the treatment of low back pain and provides minimal short term benefit for people with osteoarthritis.”
“Our results therefore provide an argument to reconsider the endorsement of paracetamol in clinical practice guidelines for low back pain and hip or knee osteoarthritis.”
These studies found that paracetamol (acetaminophen) is ineffective for the management for acute low back pain, and it calls for a reconsideration of Low Back Evidence Based Practice Guidelines inclusion of paracetamol for the management of acute low back pain.
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The evolving nature of Low Back Evidence Based Practice Guidelines is best represented in another study published in February of 2017 in the journal Annals of Internal Medicine, and is titled (16):
Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain:
A Clinical Practice Guideline From the American College of Physicians
The American College of Physicians (ACP) developed this guideline to present the evidence and provide clinical recommendations on noninvasive treatment of low back pain. The committee based their recommendations on a systematic review of randomized, controlled trials and systematic reviews published through April 2015 on noninvasive pharmacologic and non-pharmacologic treatments for low back pain. Updated literature searches were performed through November 2016 and included in their review. The article included 182 references.
The authors note that the target audience for this guideline included all clinicians; the target patient population includes adults with acute, subacute, or chronic low back pain. These authors note:
“…clinicians and patients should select from superficial heat, massage, acupuncture, or spinal manipulation…”
“For patients with chronic low back pain, clinicians and patients should initially select non-pharmacologic treatment with exercise, multidisciplinary rehabilitation, acupuncture, mindfulness-based stress reduction, tai chi, yoga, motor control exercise, progressive relaxation, electromyography biofeedback, low-level laser therapy, operant therapy, cognitive behavioral therapy, or spinal manipulation.”
“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.”
“Low-quality evidence showed no difference between acetaminophen and placebo for pain intensity or function through 4 weeks or between acetaminophen and NSAIDs for pain intensity or likelihood of experiencing global improvement at 3 weeks or earlier.”
This most recent Guideline for Low Back Pain clearly emphasized “non-pharmacologic treatment” which included spinal manipulation. Consistent with other recent Guidelines, there is a de-emphasis for the use of acetaminophen. In addition, there is a clear warning about the use of opiate drugs for these patients.
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It is no longer controversial to understand that chiropractic and spinal manipulation are safe and effective treatments for back pain (17, 18, 19, 20, 21, 22, 23). It is also commonplace for spine pain clinical practice guidelines to include chiropractic and/or spinal manipulation (10, 11, 12, 13, 14, 15, 16).
REFERENCES
