Chronic Pain Surveys Portray a World of Hurt

Chronic pain has often been depicted as a worldwide problem of epidemic proportions. Until recently, however, there has been no comparison and consolidation of the diverse surveys examining this issue, and the conclusion is that chronic pain may be a problem of even more catastrophic significance than many imagine.

An investigator at the American University of Beirut, Lebanon, conducted what is probably the first-ever extensive search of the peer-reviewed literature for epidemiological studies reporting the prevalence of chronic pain and associated factors in adults [Abu-Saad Huijer 2010]. Fourteen studies were included in this analysis, spanning 1997 to 2008, and here are some of the noteworthy findings:

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Is Staying Active Best for Acute Low-Back Pain?

According to an updated Cochrane Review, continuing normal daily activity rather than bed rest seems to be the best advice for patients with acute low-back pain. However, it appears from the evidence that it is unreasonable to expect that staying active will actually hasten recovery.

At one time, “rest”— meaning a few days to a week in bed — was the standard prescription for acute low-back pain. More recently, healthcare providers have been counseling patients to stay as active as they can. In an updated systematic review for the Cochrane Collaboration, investigators conducted an exhaustive literature search up to May 2009 for studies evaluating the effects of advice either to rest in bed or to stay active on individuals with acute low-back pain (<6 weeks duration) with or without sciatica [Dahm et al. 2010]. Although the term “sciatica” is often broadly applied to low-back disorders in which pain radiates down one or both legs, the reviewed studies defined it as low-back pain accompanied by signs of nerve compression or damage, like numbness, tingling, or weakness in the leg.

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Worrisome Cardiovascular Risks of NSAIDs Reported

In a large study spanning 9 years researchers examined cardiovascular risks, such as fatal heart attack or stroke, associated with the use of nonsteroidal anti-inflammatory drugs (NSAIDs) by otherwise healthy persons. Overall, naproxen was found to have the lowest risk of cardiovascular morbidity and mortality; however, such risks could be much greater in persons with chronic pain and other health problems.

In prior posts [here] and [here] we have described the considerable and largely overlooked risks associated with chronic use of NSAID pain-relievers, primarily gastrointestinal complications but, also, cardiovascular safety concerns. Now, new research reported in an upcoming edition of Circulation: Cardiovascular Quality and Outcomes, a journal of the American Heart Association, observes that most NSAIDs carry significant risks of cardiovascular complications [Fosbol et al. 2010].

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Does Ginger Help to Relieve Muscle Aches, Pains?

News media were abuzz recently with reports of research evidence claiming that consuming ginger could help fend off muscle aches and pains. While this may be the case for some persons to an extent, there are numerous limitations that must be considered before recommending ginger supplements as a remedy for patients with pain.

Ginger, the underground stem, or rhizome, of the plant Zingiber officinale has been used as a medicine in Asian, Indian, and Arabic herbal traditions since ancient times. Among other maladies, it has been used to treat stomach upset and nausea, as well as headache and arthritis pain. Christopher Black, PhD, and colleagues at the University of Georgia conducted a trial to examine the benefits of either raw (study 1) or heat-treated (study 2) ginger supplementation for relieving exercise-induced muscle pain [Black et al. 2010].

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Meditation May Help to Calm the Turmoil of Pain

Meditation is part of a growing list of noninvasive complementary and alternative practices that may benefit patients with pain. Results from a new study suggest that people who meditate regularly may find pain less unpleasant because their brains can better manage the stress of anticipation and the distress of pain.

In an upcoming report in the journal Pain scientists from the University of Manchester in the UK describe testing the effects of meditation practices on the anticipation and appraisal of pain [Brown and Jones 2010]. Subjects with a diverse range of meditation experience, spanning months to decades, and using a variety of “mindfulness meditation” techniques were compared with a control group of non-meditators. Measurements of anticipatory and pain-evoked brain activity, along with self-reported pain unpleasantness, were recorded in response to a painful stimulus provoked by a laser beam. The laser energies required to induce pain were equivalent in the two groups; however, meditators perceived the pain as less unpleasant than controls and the more experience with meditation a subject had the greater the reduction in perceived pain.

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Chilling Concept: Chronic Pain as a Brain Disease

Pain and the Great Brain Robbery! Part 5

There has been ongoing debate over whether chronic noncancer pain is a syndrome or a disease entity unto itself. Compelling research evidence suggests that no matter what brought on the condition — acute injury, precipitating disease, or unknown factors — chronic pain ultimately manifests as a distinct brain disease, which impacts all aspects of the individual’s life and may become irreversible. Appropriate clinical response to this alarming notion could require prompt diagnosis followed by aggressive, multimodal pain management early in the course of disease progression to forestall or ameliorate potentially serious and incapacitating brain damage.

Need for a Paradigm Shift
In an excellent review examining current perceptions among healthcare professionals and the public regarding chronic pain, Tracey and Bushnell [2009] observe that chronic pain has historically been labeled as a syndrome (or group of syndromes or symptoms consistently occurring together). They argue, however, that recent evidence coming largely from neuroimaging research strongly advocates for chronic pain being labeled as a disease. Therefore, they contend, “a paradigm shift in our thinking is needed if we are to better diagnose, manage, and treat chronic pain.”

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Meds for Fibromyalgia Compared & Contrasted

The perfect medication for treating fibromyalgia syndrome has apparently yet to be discovered, as a recent systematic review comparing duloxetine, milnacipran, and pregabalin found. Each of these medications approved for fibromyalgia has particular strengths and weaknesses that may affect prescribing decisions and patient outcomes.

Researchers in Germany conducted a systematic review of available evidence comparing benefits and harms of the 3 FDA-approved drugs for the treatment of fibromyalgia syndrome (FMS): duloxetine (DLX; Cymbalta®, Lilly), milnacipran (MLN; Savella®, Forest Labs), and pregabalin (PGB; Lyrica®, Pfizer) [Hauser et al. 2010]. The authors searched MEDLINE, SCOPUS, Cochrane Central Register of Controlled Trials, and sought unpublished data from the databases of the FDA, U.S. National Institutes of Health, and industry through May 2009 for randomized controlled trials. Outcomes of interest were symptom reduction (pain, fatigue, sleep disturbance, depressed mood, health-related quality of life), and adverse events.

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Vitamin D for Pain: Dosing & Testing Suggestions

The potential benefits of vitamin D for various chronic pain conditions continue to generate much interest. As a followup to our earlier reports on this topic, we offer further recommendations for appropriate vitamin D dosing and patient monitoring that should be of interest to practitioners.

In response to our original research reports on “Vitamin D for Chronic Pain” ([available here] and a version of which appeared in the July/August 2008 edition of the journal Practical Pain Management [PDF available here]), Gordon Ko, MD, and Leigh Arseneau, BSc, ND, submitted a letter to the journal editor offering their own “clinical pearls” for vitamin D dosing and monitoring in patients with pain syndromes [Ko and Arseneau 2008]. These practitioners are with the Canadian Centre for Integrative Medicine, Markham, and the University of Toronto, Ontario, Canada. Here are their recommendations for dosing and testing [our notes are in italics]…

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Value of Opioid Agreements and UDT Challenged

Experts in pain management often recommend opioid treatment agreements and urine drug testing (UDT) as strategies for reducing opioid analgesic misuse or abuse. However, a systematic review of the research literature failed to discover any solid evidence to justify the use of these strategies in everyday clinical practice.

A team of investigators led by Joanna L. Starrels, MD, MS, of Albert Einstein College of Medicine and Montefiore Medical Center, Bronx, New York, searched MEDLINE, PsycINFO, EMBASE, and the Cochrane Central Register of Controlled Clinical Trials through the second week of June 2009 to identify studies of the association of treatment agreements and UDT with opioid misuse [Starrels et al. 2010]. They selected only original research addressing outpatients with chronic noncancer pain prescribed opioids for at least 3 months, with a sample size of 50 participants or more, and published in English, Spanish, or French. The outcome of opioid misuse was variously defined in their search as drug abuse, drug misuse, aberrant drug-related behavior, diversion, or addiction.

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A Better Way to Diagnose Fibromyalgia Proposed

The American College of Rheumatology (ACR) has proposed new diagnostic criteria for fibromyalgia that include common symptoms such as fatigue, sleep disturbances, and cognitive problems, as well as pain. This could mean saying goodbye to counting tender points and facilitate more appropriate diagnoses.

Writing in the May issue of Arthritis Care & Research a team of investigators describe a multicenter assessment of 829 previously diagnosed patients with fibromyalgia and controls [Wolfe et al. 2010]. They used physician physical and interview examinations, including a newly-developed widespread pain index (WPI) and a symptom severity (SS) scale. Previous diagnostic criteria, established in 1990 by the ACR, required patients to have widespread pain in all 4 quadrants of their body for a minimum duration of 3 months and experience moderate pain and tenderness at a minimum of 11 of 18 specified tender points.

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Older Patients Denied Adequate Pain Relief

Persons older than 65 years of age are less likely to receive strong analgesics for moderate to severe pain than younger patients complaining of comparable pain, according to researchers at the 2010 Annual Meeting of the American Geriatrics Society (AGS). Specific reasons for this are as yet undetermined.

A nationwide study found that strong-opioid therapy was prescribed to 36% of patients aged younger than 65 years, compared with 31% of patients aged 65 to 74 years and 25% of patients 75 years of age or older. Investigator Aarti Patel, PharmD, said during a poster presentation on May 13, 2010, "Results from [a] large national survey suggest that inadequate analgesia and undertreatment of pain are common, particularly among older patients." The survey included responses from nearly 57,000 patients being treated for pain post surgery, osteoarthritis flares, trauma or injury, acute low back pain, acute neck pain, acute shingles, or another acute condition. In each age group about 95% of the patients indicated they were suffering from moderate to severe pain due to the various conditions. Overall, "we observed that the older the patient was, the less likely it was that the patient would receive adequate pain relief," Patel noted. She further said that researchers are now trying to determine the reasons for the under-prescribing of adequate pain relief in the elderly.

COMMENT: In the above study, which was funded by Ortho-McNeil Janssen Scientific Affairs, the greatest absolute risk difference was 11% (36% minus 25%), which may not seem enormous but could account for millions of undertreated elderly persons on a national scale. The American population aged 65 years or older numbered 37 million in 2006 and it is expected to nearly double by 2030. It is well known that poorly controlled pain in older patients can negatively affect quality of life, resulting in depression, sleep disturbance, social isolation, cognitive impairment, and other detriments. At the same time, there have been concerns about strong analgesics incurring greater adverse events in the elderly, so achieving a balance of risks-benefits can be challenging. For the most current guidelines from the AGS on the “Pharmacological Management of Persistent Pain in Older Persons” [click here].

SOURCE:AGS presentation title: The Undertreatment of Moderate to Severe Pain Among Elder and Non-Elderly Patients; Abstract A99. Reported in Doctor’s Guide, May 14, 2010 [available here].

Tai Chi May Offer Benefits for Chronic Pain

Tai Chi, a low-impact martial art, has been associated with significant improvements in balance, strength, flexibility, cardiovascular and respiratory function, as well as pain reduction and improved quality of life. Researchers at Tufts University School of Medicine, Boston, conducted a systematic review demonstrating that Tai Chi also benefits psychological health.

A search of English and Chinese databases through March 2009 revealed 40 high-quality studies, encompassing 3,817 subjects (including both community-dwelling healthy participants and patients with chronic conditions) and assessing 29 psychological measurements [Wang et al. 2010]. Twenty-three of 33 clinical trials reported that 1 hour to 1 year of regular Tai Chi increased psychological well-being, including statistically significant reductions of stress, anxiety, and depression, plus enhancements of mood and emotion. Seven observational studies with relatively large sample sizes further reinforced the beneficial association between Tai Chi practice and psychological health.

COMMENT: Definitive conclusions were limited due to variations in study designs and group comparisons, heterogeneous outcomes, and inadequate controls. Therefore, high-quality, well-controlled, and longer-term randomized trials would be helpful to better inform clinical decisions. Overall, however, Tai Chi appears to be associated with improvements in psychological well-being that could be important for persons with chronic pain conditions. This also is an area ripe for brain imaging studies to determine if the psychological improvements due to Tai Chi correspond with an amelioration of detrimental changes in brain structure and function in persons with chronic pain conditions.

REFERENCE: Wang C, Bannuru R, Ramel J, et al. Tai Chi on psychological well-being: systematic review and meta-analysis. BMC Compl Alt Med. 2010 (May 21);10(23) [article here].

June2010 – Pain Product Announcements & Warnings

Featured Items: intranasal ketorolac tromethamine (Sprix Nasal Spray) approval; milnacipran HCl (Savella) safety warning; tramadol-related suicide warning (Ultram and Ultracet); proton pump inhibitor (PPI) class-wide safety notice. — Brand names are trademarks of their respective manufacturers. Compiled by Winnie Dawson, MA, RN, BSN.

Intranasal Ketorolac Tromethamine (Sprix™ Nasal Spray) — FDA Approved
Roxro Pharma announced the May 2010 approval of an intranasal formulation of ketorolac tromethamine, a nonsteroidal anti-inflammatory drug (NSAID) absorbed through nasal mucosa. The novel intranasal formulation — indicated for the short-term management of moderate to moderately-severe pain — has been shown to achieve peak blood levels as quickly as an intramuscular injection. Data from 4 controlled, efficacy trials reported meeting primary endpoints in each trial and phase 3 studies in surgical patients reported statistically significant reductions in measures of pain during 48 hours versus placebo. The easy-to-use intranasal formulation also showed a 26%-36% reduction in morphine use during a 48-hour period when compared with placebo. All ketorolac formulations should be prescribed for the shortest duration possible, not exceeding 5 days. The most frequently reported adverse effect was mild, transient nasal discomfort. Intranasal ketorolac is contraindicated in patients with a history of cerebrovascular bleeding, gastrointestinal bleeding, or advanced renal impairment. For complete information, see the Sprix prescribing information, Medication Guide, and patient instructions (combined) at the Roxro Pharma website.

Milnacipran HCl (Savella®) — Safety Warning
The FDA issued a February 2010 warning to alert practitioners that a potentially life-threatening reaction can occur with SNRIs and SSRIs, including Milnacipran HCl (Savella), which was approved in 2009 for the treatment of fibromyalgia symptoms. Serotonin syndrome symptoms or neuroleptic malignant syndrome-like reactions can include changes in mental status, neuromuscular aberrations, autonomic instability, or gastrointestinal symptoms. Reports have been primarily associated with concomitant use of dopamine antagonists. Read the FDA safety warning and the new label, approved in May 2010.

Tramadol HCl (Ultram®) and Tramadol HCl/acetaminophen (Ultracet®) — Suicide Warning
The FDA and PriCara, the maker of 2 formulations of tramadol — a centrally-acting synthetic opioid analgesic — announced that a warning of suicide risk has been added to the labels of Ultram and Ultracet. The drugs are used for the management of moderate to moderately severe chronic pain. Following reports of tramadol-related deaths in patients with emotional disturbances, suicidal ideation, or histories of drug or alcohol misuse, the revised label instructs prescribers to use caution in patients with similar histories. Tramadol can intensify the effects of other opioids, alcohol, or illicit drugs that cause central nervous system depression. See the FDA notice and “Dear Healthcare Professional” letters for each product for further information.

Proton Pump Inhibitors (PPIs) — Class-wide Labeling Revision The FDA announced a May 2010 safety revision to the prescription and over-the-counter (OTC) labels for the class of drugs known as proton pump inhibitors (PPIs). The new warning cautions healthcare providers and consumers of a possible increased risk of fractures of the hip, wrist, and spine with the use of these medications — including Nexium®, Prilosec,® Prevacid®, Protonix®, Aciphex®, Vimovo™, Dexilant™, and Zegerid® formulations. This is an important concern for patients taking PPIs to manage gastroesophageal reflux disease or for those taking a proton pump inhibitor as gastroprotective therapy when using nonsteroidal anti-inflammatory drugs (NSAIDs) for chronic pain and inflammation. Analysis of several studies, primarily of adults 50 years of age and older, showed that people who had been taking high-dose prescription PPIs or used them for at least one year had the greatest increased risk of fracture. Healthcare providers are encouraged to consider the risk-benefit ratio and evaluate the potential value of a lower dose or shorter course of therapy on a case-by-case basis. For complete information, including the epidemiological study references supporting the fracture risk evaluation, see the FDA safety communication.

Note: In March 2011, the FDA reversed their decision and decided that a warning on OTC PPI products regarding bone fracture was unwarranted. See FDA notice [here].