Pain Research: All That Glitters is Not Gold

Part 2 – A Hierarchy of Evidence

Just because a pain research study is published does not mean it is accurate, unbiased, valid, or useful for any clinical or decision making purpose. The truth is that much pain-related research literature is simply not worth reading, and sifting out the golden nuggets of worthwhile research from fool’s gold can be a challenging task for any healthcare provider or patient.

The above applies no matter how prestigious the journal, how rigorous the peer-review process, or how gleaming the reputations of the researchers. In fairness, however, it must be acknowledge that it is much easier to criticize research than it is to actually do research. And, even with its limitations and shortcomings, research in pain management provides the best hope of finding more effective treatments for improved patient care. The danger is that faulty or deficient research may come to overshadow the good, resulting in strong treatment recommendations based on weak evidence, as has happened in some guidelines in the pain field [previously discussed in a “Pain-Topics e-Briefing” here].

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'Surgeon Enthusiasm' Increases Low Back Surgeries

A new study proposes that surgeons in some geographic areas are more likely to recommend surgery for lower back problems, and a major driving factor appears to be "surgeon enthusiasm" for the procedures. In contrast, surgery rates are unrelated to comparable enthusiasm among primary care physicians or patients.

Reporting in the March 14, 2011 issue of the journal Spine researchers examined healthcare databases in Ontario, Canada, spanning 2002 to 2006 to identify more than 10,000 surgeries — such as decompression/laminectomy or fusion — performed for degenerative disease of the lumbar spine in patients ≥50 years of age. Disease processes included conditions, like "slipped" vertebrae caused by bone degeneration (spondylolisthesis) and narrowing of the spinal canal (stenosis), for which there is allegedly strong evidence for surgical effectiveness. The researchers found that there were significant variations in spinal surgery rates across small geographic regions.

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Could New Opioid Regs Lead to Tsunami of Heroin?

Various states in the U.S. and federal agencies seem justifiably determined to stem the rising tide of opioid-analgesic abuse, addiction, and diversion. However, an unintended consequence of new approaches for ameliorating these problems might be a powerful resurgence of heroin overdoses and deaths.

As noted in a recent UPDATES article [here], Washington state has forged new and restrictive rules governing the management of chronic noncancer pain with opioid analgesics. Along with that, some manufacturers have introduced new, abuse-deterrent formulations of prescription opioids. Expectedly, such measures would avert the misuse and abuse of such products.

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How to Make Practical Sense of Pain Research

Part 1 – Getting Started

At a time when pain disorders of all types are reaching epidemic proportions, pain research is proliferating at an accelerating pace. Yet, understanding research reports and articles, and translating their results into better patient care, has never been more difficult. This new series of UPDATES articles teaches readers the secrets of distinguishing good research from bad and how to decode the sometimes mystifying language of researchers and their statisticians.

Just as juries need good evidence to reach prudent verdicts, healthcare providers need good evidence as a guide for better decision making in treating patients with pain. And, patients need to understand reasons behind treatment recommendations so they can be active participants in their care.

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Lumbar Fusion Surgery for Back Pain Questioned

There have been variable successes of lumbar-spine fusion surgeries reported in patients with work-related low-back injuries causing chronic pain. A new study proposes that long-term outcomes, including return to work, are actually better without the surgery, but there are some possible biases in this investigation to consider.

Writing in the February 15, 2011 edition of the journal Spine, researchers report a retrospective case-control study of patients receiving workers’ compensation who either underwent lumbar-spine fusion (arthrodesis) surgery for job-related back injuries (cases) or had similar injuries and chronic pain but did not undergo surgery (controls) [Nguyen et al. 2011]. Multiple outcomes were assessed at 2 years after the date of injury (for controls) or 2 years after date of surgery (for cases) including: return to work (RTW), permanent disability, and opioid utilization in all subjects; and, also postsurgical complications and reoperation status for subjects having lumbar fusion.

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Patient Informed Consent in Pain Care: Neglected?

The pain management field has been so focused on concerns about medication misuse and abuse, that there has been little discussion of a most critical element in the treatment process — patient informed consent, whether for pharmacologic or nondrug therapy. A recent commentary in JAMA highlights the importance of this often-neglected component of proper patient care.

Writing in the March 16, 2011 edition of the Journal of the American Medical Association (JAMA), Yael Schenker, MD, and Alan Meisel, JD, from the University of Pittsburgh, state that “Informed consent is a fundamental tenet of the U.S. health care system, rooted in the ethical principles of respect for patient autonomy and enhanced patient well-being. As famously stated in a pivotal court case, ‘every human being of adult years and sound mind has a right to determine what shall be done with his own body’” [Schenker and Meisel, 2011].

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Manipulative Therapy for Low-Back Pain Reviewed

Spinal manipulative therapy (SMT) is an intervention that is widely practiced by a variety of healthcare professionals, such as chiropractors, osteopaths, and physiotherapists; however, the effectiveness of this form of therapy for the management of chronic low-back pain often has been questioned. Now, an extensive review and analysis of available research evidence has found that SMT appears to be no better or worse than other existing therapies for patients with chronic low-back pain conditions.

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Source of Migraine Pain: Superficial Vasodilation

There has been considerable debate as to whether the vascular component of migraine pain arises from vessels within the skull (intracranial) or more superficial extracranial vessels, or both. A recent review proposes that a primary influence on migraine pain is exerted by vasodilation of vessels originating from the external carotid artery and effective therapies take this into account.

Writing in the March 2011 edition of the journal Headache, Elliot Shevel, a headache specialist in Johannesburg, South Africa, acknowledges that there has been some ongoing debate about vascular origins of migraine headache. Some have questioned whether vasodilation plays a significant role in migraine pain at all; however, in this review, Shevel proposes that (1) vasodilatation is indeed a source of pain in migraine; (2) this dilatation does not involve the intracranial vasculature; (3) the extracranial terminal branches of the external carotid artery are the most significant source of pain in migraine [Shevel 2011].

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CDC Study Ties Opioid Analgesics to Birth Defects

According to a newly published study from the U.S. Centers for Disease Control and Prevention (CDC), women who take opioid analgesics such as codeine or hydrocodone shortly before or during early pregnancy may have an increased risk of delivering babies with certain birth defects. While news media reports made this seem like a dire situation, careful examination of the data suggests that the problems are small and not yet clearly defined.

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New Research Links NSAIDs to Erectile Dysfunction

Some data suggest a potential relationship between vascular inflammation processes and erectile dysfunction (ED); therefore, without other complicating factors, lower incidences of ED might be expected among regular users of oral nonsteroidal anti-inflammatory drugs (NSAIDs). However, just the opposite was reported in a recently published, large-scale research study: frequent NSAID users suffered more ED than non-users.

Writing in the February 22, 2011 online edition of the Journal of Urology, researchers from Kaiser Permanente managed care plans in California examined the association between oral NSAID use and ED in a large, ethnically diverse cohort of men enrolled in the California Men’s Health Study [Gleason et al. 2011]. Subjects for this prospective cohort study included males aged 45 to 69 years of age who had enrolled in the managed care plans from January 2002 to December 2003.

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Biased UDT Research Distorts Opioid Misuse, Again

As an aid for monitoring patient responsiveness to opioid analgesic therapy, urine drug testing (UDT) can be useful in providing better pain care. However, the field is becoming fraught with questionable research studies sounding alarms about opioid misuse detected by UDT. Such studies, often supported by UDT laboratories, seem more like biased infomercials than valid clinical investigations, and a recently published report provides yet another example of this.

The investigation in question assessed the health economic burden imposed by long-term opioid analgesic users and whether nonadherence with prescribed opioid regimens, as determined by UDT, increases healthcare costs in these patients [Leider et al. 2011]. The article appeared in the January 2011 edition of the American Journal of Managed Care and was sponsored by Ameritox, a drug-testing services laboratory.

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Mar2011 – Pain Product Announcements & Warnings

Featured Items: proton pump inhibitor drugs safety warning; gabapentin oral solution approval; sumatriptan subcutaneous injection (Alsuma Auto-Injector) product availability; recall implantable drug pump (Medtronic SynchroMed); recall hydrocodone bitartrate and acetaminophen tablets. — Brand names are trademarks of their respective manufacturers. Compiled by Winnie Dawson, MA, RN, BSN.

FDA Safety Warning — Proton Pump Inhibitors May Cause Low Magnesium
The U.S. FDA has announced that proton pump inhibitors, or PPIs, often referred to class-wide as “prazoles,” may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time (in most cases, longer than one year). Low serum magnesium levels can result in serious adverse events including muscle spasm (tetany), irregular heartbeat (arrhythmias), and convulsions (seizures); however, patients do not always have these symptoms.

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