The Evidence Continues to Grow
The American opiate crisis and its resulting heroin/fentanyl addiction epidemic began in 1980 when the prestigious medical journal, The New England Journal of Medicine, indicated that “less than one percent” of patients given opiate drugs for pain became addicted (1). Sadly, this statistic was not based on valid scientific data. It was based on a short letter-to-the editor by physicians Jane Porter, MD, and Hershel Jick, MD, from Boston University Medical Center. This publication began the relentless marketing of opiate drugs for pain, supported by the concept that these drugs were not addictive.
Six years later, in 1986, prescribing opiates for chronic pain was further enhanced when physicians Russell Portenoy, MD, and Kathleen Foley, MD, published a small case series (38 subjects) that concluded that chronic opioid analgesics use was safe in patients with no history of drug abuse (2).
Yet, it is stunning to realize that until this year (2017), there were no published studies of opiate therapy for chronic pain that evaluated long-term (greater than one year) outcomes related to pain, function, or quality of life. Most of the placebo-controlled randomized clinical trials pertaining to opiate drugs were less than six weeks in duration (3).
The current issue of The Back Letter (July 2017) profiles the use of opiate drugs for chronic back pain with the headline (4):
Landmark Trial Punctures the Myth That Opioids Provide Powerful Relief of Chronic Pain
The opening comments from this article are:
“The deadly opioid overtreatment epidemic picked up steam in the late 1980s and early 1990s with the misguided notion that opioids are painkillers that can be used safely and effectively in the long-term treatment of chronic back pain—or other forms of non-cancer chronic pain.”
“The intervening years—and as many as 300,000 deaths in the related opioid overdose epidemic—have rebutted the idea that opioids can be used safely on a mass basis. More than 30,000 Americans will die in 2017 as the result of opioid overdoses. And the opioid overdose epidemic is still increasing in ferocity in many quarters.”
The landmark trial referenced is the first randomized controlled trial (RCT) with long-term follow-up comparing opioids with non-opioid medications. It is from the Minneapolis Veterans Health Care System (5). The authors found that opioids provided no better pain relief for patients with low back pain than other safer approaches. Comments pertaining to the study include (4):
“It is the first clinical trial comparing opioid and non-opioid medications with long-term follow-up. It provides strong evidence that opioids should not be the first line of treatment for chronic musculoskeletal pain, given that there were similar changes in pain and function with non-opioids.”
“A lot of people at the conference were impressed with this study, as it confirmed the clinical impressions of many physicians that opioids are not as effective as advertised.”
“Opioids are perceived as strong pain relievers, but our data showed no benefits of opioid therapy over non-opioid medication therapy for pain.”
“Opioids provided no advantage in terms of function at the 12-month follow-up mark, and patients in the opioid wing of the study actually reported marginally more pain at 12 months than those in the non-opioid group.”
“The data do not support opioids’ reputation as powerful painkillers.”
“Opioids are not achieving the benefits for which they are marketed. And everyone is now well aware of the adverse effects of opioids.”
A related article from the same issue of The Back Letter is titled (4):
What If the New Opioid Study Had Been Published In 1995?
How Many Lives Would Have Been Saved?
Comments from this article note that the opiate drug movement has been one of the most “destructive” and “among the most lethal in modern medical history.” The article notes:
“Had this study been conducted and published in 1995, it might have saved 300,000 lives or more—lives lost to opioid overdoses.”
“The opioid overtreatment epidemic and resulting heroin/fentanyl addiction epidemic continues to kill more than 30,000 US residents per year. And with an estimated eight million Americans on long-term opioid therapy, this issue may bedevil US society for decades.”
Opiate drugs continue their grip on America. As of this year (2017), four states (Missouri, Mississippi, Ohio, Illinois) have officially sued several of the drug company producers of opiates in an effort to recapture compensation for societal devastation caused by these drugs (6). Interestingly, these lawsuits against the drug companies are also being filed at the local level. Santa Clara County (Northern California) and Orange County (Southern California) have filed similar lawsuits in an effort to recapture some of the incredible local financial burdens associated with the opiate drug epidemic. American Indian reservations are taking a similar approach (6).
In spite of all of this, opiate drugs continue to be overly prescribed for patients with back pain (13). Yet, over the past decade, Clinical Practice Guidelines for the treatment of back pain have increasingly moved away from prescribing drugs, especially opiates, and have emphasized more on the non-drug approaches to the back pain problem:
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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The October 2007 issue of the journal Annals of Internal Medicine published the comprehensive and authoritative (7, 8):
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 (7):
Diagnosis and Treatment of Low Back Pain:
A Joint Clinical Practice Guideline from the
American College of Physicians and the American Pain Society
Recommendations from these guidelines include:
- 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.
- For patients who do not improve with self-care options, clinicians should consider the addition of non-pharmacologic therapy with proven benefits—for 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.
This publication notes that acceptable non-pharmacologic options for acute, subacute, and chronic low back pain include spinal manipulation. In fact, spinal manipulation is the only non-drug treatment recommendation for acute low back pain in this document. The 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.”
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The second guideline 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 (8):
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 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 was 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.”
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 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 (9):
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 systematic review of published articles on the topic, as well as to 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 (10):
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, ... as first-line treatments.”
These Guidelines 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.”
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The evolving nature of Low Back Evidence Based Practice Guidelines is best represented in another study published in April of 2017 in the journal Annals of Internal Medicine, and is titled (11):
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 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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As noted above, Clinical Practice Guidelines are systematically developed based upon “evidence from rigorous systematic reviews and synthesis of the published medical literature.” As such, additions to the published medical literature will be incorporated into future updates of clinical practice guidelines.
A recent study adds to the evidence that spinal manipulation is a safe and appropriate treatment for patients suffering from acute low back pain. The article was published in the Journal of the American Medical Association in April 2017, and titled (12):
Association of Spinal Manipulative Therapy With
Clinical Benefit and Harm for Acute Low Back Pain:
Systematic Review and Meta-analysis
The authors of this study were from the:
- Veterans Affairs Medical Center, Los Angeles
- University of California, Los Angeles
- RAND Corporation, Santa Monica
- Veterans Affairs Healthcare System, Phoenix
- Veterans Affairs Medical Center, Rochester
- Minneapolis Veterans Affairs Healthcare System
- White River Junction Veterans Affairs Medical Center, Vermont
The objective of this article was to systematically review studies of the effectiveness and harms of spinal manipulative therapy (SMT) for acute (=6 weeks) low back pain. The authors found 26 eligible randomized clinical trials (RCTs).
The measurement outcomes used included:
- Pain, measured by either the 100-mm visual analog scale, 11-point numeric rating scale, or other numeric pain scale
- Function (measured by the Roland Morris Disability Questionnaire or Oswestry Disability Index)
The spinal manipulative therapy (SMT) was provided by physical therapists in 13 studies, chiropractors in 7 studies, medical doctors in 5 studies, and osteopathic physicians in 3 studies. The studies reviewed provided moderate-quality evidence that SMT has a statistically significant association with improvements in back pain and in function. The authors made the following comments:
“Back pain is among the most common symptoms prompting patients to seek care. Lifetime prevalence estimates of low back pain exceed 50%.”
“Acute low back pain is common and spinal manipulative therapy (SMT) is a treatment option.”
“No randomized clinical trials reported any serious adverse event. Minor transient adverse events such as increased pain, muscle stiffness, and headache were reported 50% to 67% of the time.”
“Among patients with acute low back pain, spinal manipulative therapy was associated with modest improvements in pain and function at up to 6 weeks, with transient minor musculoskeletal harms.”
“In this systematic review and meta-analysis of 26 randomized clinical trials, spinal manipulative therapy was associated with statistically significant benefits in both pain and function.”
“Thrust-type manipulation may be more effective than nonthrust-type manipulation.”
“Mild, transient harms were reported by 50% to 67% of patients. The most commonly reported adverse effects were local discomfort or increased pain.”
“No serious harms were reported in any of these studies.”
Many studies pertaining to the use of spinal manipulation target its use for chronic back pain sufferers. This study targets spinal manipulation for acute low back pain. The study shows that spinal manipulation, including thrust-type spinal manipulation is both safe and effective for patients suffering from acute low back pain.
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Richard Deyo, MD, is the contemporary leader in the contribution and understanding to Clinical Practice Guidelines pertaining to low back pain. He is a primary care internist who holds the title of Professor of Evidence-Based Family Medicine at Oregon Health and Science University. He is the Kaiser-Permanente Endowed Professor of Evidence-Based Medicine in the Department of Family Medicine at Oregon Health and Science University. Dr. Deyo is a Deputy Editor of Spine and a member of the Editorial Board of the Back Review Group of the Cochrane Collaboration. He is co-editor of the book Evidence-Based Clinical Practice: Concepts and Approaches.
Dr. Deyo has a long-standing research interest in measuring patient function, involving patients in clinical decisions, and managing low back pain. He has a national and international reputation for research on back pain. He has authored or co-authored more than 400 peer-reviewed scientific articles, mostly concerning back pain; PubMed places the number at 426 (July 13, 2017).
The above article by Paige et at (12) generated the following editorial, published in the Journal of the American Medical Association, and titled (13):
The Role of Spinal Manipulation in the Treatment of Low Back Pain
In this editorial, Dr. Deyo notes that the etiology of back pain is often unclear. “It is important to acknowledge that for many patients with acute back pain without radiculopathy, a precise pathoanatomical cause of the pain cannot be identified.” Yet, at present, there are approximately 200 treatment options available to treat low back pain.
Dr. Deyo notes that this article by Paige and colleagues (12) presents a sophisticated systematic review and meta-analysis, including 26 eligible randomized trials of manipulation for acute back pain (less than six weeks). Their analysis was based on a thorough search of the literature. The authors concluded that for patients with acute low back pain, spinal manipulative therapy was associated with modest improvement in pain and modest improvements in function in comparison with sham manipulation, usual care, or other treatments. Dr. Deyo notes that none of the randomized trials or large observational studies reviewed by Paige et al identified any serious complications from spinal manipulation for back pain.
Dr. Deyo states:
“Low back pain is among the most common reasons for prescribing opioids in the United States. Among patients initiating opioid therapy, about 5% become long-term opioid users, with associated risks of dependency, addiction, and overdose.”
“Among patients taking non-steroidal anti-inflammatory drugs, renal function abnormalities occur in approximately 1% of patients, and superficial gastric erosions or asymptomatic ulcers may occur in up to 5% to 20% of users.”
“Renal and gastrointestinal adverse effects of non-steroidal anti-inflammatory drugs are common.”
Pertaining to spinal manipulation, Dr. Deyo makes these comments:
“Spinal manipulative therapy (SMT) is a controversial treatment option for low back pain, perhaps in part because it is most frequently administered by chiropractors.”
“Chiropractic care is popular today with the US public. According to a 2012 report, among patients with back or neck pain, approximately 30% sought care from a chiropractor.”
“In a 2013 survey by Consumer Reports magazine involving 14,000 subscribers with low back pain, chiropractic care had the largest proportion of ‘highly satisfied’ patients.”
“The conclusions of the systematic review by Paige et al are generally consistent with another recently completed systematic review and clinical guideline from the American College of Physicians.”
“It appears that SMT is a reasonable treatment option for some patients with low back pain. The systematic review by Paige et al suggests a treatment effect similar in magnitude to non-steroidal anti-inflammatory drugs.”
“If manipulation is at least as effective and as safe as conventional [drug] care, it may be an appropriate choice for some patients with uncomplicated acute low back pain.”
“This is an area in which a well-informed patient’s decisions should count as much as a practitioner’s preference.”
SUMMARY
The evidence that spinal manipulative therapy is both safe and effective for patients suffering from acute or chronic low back pain continues to grow. This evidence is being published in the best scientific journals by the world’s leading experts on back pain.
In contrast, the use of drugs to treat back pain patients, especially opiate drugs, is continuing to be questioned for both its lack of effectiveness and risks of addiction and harm.
REFERENCES
- Porter J, Jick H; New England Journal of Medicine; 1980, 302(2): 123.
- Portenoy RK, Foley KM; Chronic use of opioid analgesics in non-malignant pain: Report of 38 cases, Pain, 1986; 25:171ñ86.
- Dowell D et al.; CDC Guideline for Prescribing Opioids for Chronic Pain—United States; 2016, JAMA, 2016; 315(15): 1624ñ45.
- Wiesel SW, Executive Editor; Landmark Trial Punctures the Myth That Opioids Provide Powerful Relief of Chronic Pain; The Back Letter; Volume 32, Number 7, July 2017.
- Krebs EE et al.; Effectiveness of opioid therapy vs. non-opioid medication therapy for chronic back & osteoarthritis pain over 12 months. Presented at the annual meeting, Society for General Internal Medicine, Washington DC, 2017.
- Semuels A; Are Pharmaceutical Companies to Blame for the Opioid Epidemic?;The Atlantic Daily; June 2, 2017.
- Roger Chou, MD; Amir Qaseem, MD, PhD, MHA; Vincenza Snow, MD; Donald Casey, MD, MPH, MBA; J. Thomas Cross Jr., MD, MPH; Paul Shekelle, MD, PhD; and Douglas K. Owens, MD, MS; Diagnosis and Treatment of Low Back Pain; Annals of Internal Medicine; Volume 147, Number 7, October 2007, pp. 478-491.
- Roger Chou, MD, and Laurie Hoyt Huffman, MS; Non-pharmacologic Therapies for Acute and Chronic Low Back Pain; Annals of Internal Medicine; October 2007, Volume 147, Number 7, pp. 492-504.
- Globe G, Farabaugh RJ, Hawk C, Morris CE, Baker G, DC, Whalen WM, Walters S, Kaeser M, Dehen M, DC, Augat T; Clinical Practice Guideline:
- Chiropractic Care for Low Back Pain; Journal of Manipulative and Physiological Therapeutics; January 2016; Vol. 39; No. 1; pp. 1-22.
- Wong JJ, Cote P, Sutton DA, Randhawa K, Yu H, Varatharajan S, Goldgrub R, Nordin M, Gross DP, Shearer HM, Carroll LJ, Stern PJ, Ameis A, Southerst D, Mior S, Stupar M, Varatharajan T, Taylor-Vaisey A; Clinical practice guidelines for the noninvasive management of low back pain: A systematic review by the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration; European Journal of Pain; Vol. 21; No. 2 (February); 2017; pp. 201-216.
- 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; For the Clinical Guidelines Committee of the American College of Physicians; Annals of Internal Medicine; April 4, 2017; Vol. 166; No. 7; pp. 514-530.
- Paige NM, Miake-Lye IM, Booth MS, Beroes JM, Mardian AS, Dougherty P, Branson R, Tang B, Morton SC, Shekelle PG; Association of Spinal Manipulative Therapy With Clinical Benefit and Harm for Acute Low Back Pain: Systematic Review and Meta-analysis; Journal of the American Medical Association; 2017 Apr 11;317(14):1451-1460.
- Deyo RA; The Role of Spinal Manipulation in the Treatment of Low Back Pain; Journal of the American Medical Association. April 11, 2017; Vol. 317; No, 14; pp. 1418-1419.
