 November-December 2007; Issue 12
This edition of News/Research Updates was researched/compiled by Winnie Dawson, MA, RN, BSN [WD], and edited by Stewart B. Leavitt, MA, PhD [SBL]. Medical reviewers were: James D. Toombs, MD; Lee A. Kral, PharmD, BCPS; Paul W. Lofholm, PharmD, FACA; Seth I. Kaufman, MD; Steven Tucker, MD, FACP. Posting Date: December 26, 2007.
Where noted, product brand names are for informational purposes only and are registered trademarks of their respective manufacturers. In some cases, additional brands may be available for specific products.
 Access to all external URL links was checked prior to posting; however, some may change or become obsolete over time and will no longer function. This is beyond our control.
Lack of Vitamin D May Worsen Chronic Pain
At the October 2007 American Society of Anesthesiologists annual meeting, researchers from the Mayo Clinic reported on the prevalence and clinical correlation of vitamin D deficiencies in patients with chronic pain. Patients (n = 267) with varied pain etiologies from an outpatient pain center were tested for levels of serum vitamin D and asked to complete a questionnaire regarding their general health. Researchers also recorded the dose and duration of opioid medication intake.
Vitamin D levels were inadequate in 26% of patients. (Levels were considered inadequate when the serum 25-hydroxyvitamin D level was 20 ng/mL or less.) Among patients taking opioids (n = 140), 27% had inadequate vitamin D levels and the mean morphine equivalent dose in those patients was almost twice that of the group with adequate vitamin D levels (133.5 mg/d vs 70.0 mg/d; p = 0.001). Additionally, patients with inadequate vitamin D levels had taken opioids significantly longer (mean 71 months) than those with adequate levels (mean 44 months, p = 0.023). Furthermore, the vitamin D deficient group reported poorer physical functioning and overall health perception.
Clinical Implications: The researchers positioned their investigation as a pilot study, although a reasonably large number of patients were included. Clearly, the results suggest that vitamin D deficiencies may be an unrecognized contributing factor to pain and neuromuscular dysfunction in some patients with chronic pain. [Additionally, opioids may suppress the endocrine system, indirectly reducing vitamin D levels and contributing to osteoporosis. - SBL.].
Reference: Hooten WM, Turner MK, Schmidt JE. Prevalence and clinical correlates of vitamin D in adequacy among patients with chronic pain. American Society of Anesthesiologists 2007 annual meeting, San Francisco. October 13-17, 2007. Abstract A1380
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Vitamin D Eases Joint Pain in Patients with Cancer
At the San Antonio Breast Cancer Symposium on December 16, 2007, Qamar Khan, MD, of the Kansas University Medical Center presented evidence that maintaining adequate levels of vitamin D may help reduce or eliminate joint pain in patients with cancer.
Khan’s study examined the vitamin D levels of women with breast cancer and found that about 75% of them who were about to undergo treatment and experienced joint pain had insufficient levels of vitamin D. After administering the vitamin their joint pain was reduced. And, besides having less joint pain, Khan said that vitamin D supplements also seemed to decrease the amount of fatigue that patients experienced.
[Clinical Comment: Kahn noted that his research was preliminary and could not conclusively determine that vitamin D was what reduced the amount of pain or fatigue; however, the findings are supported by other research in patients without cancer <see item above>. He hopes to have more conclusive evidence in about 6 months and to do a full clinical trial of vitamin D and its effects on cancer patients. At the least, he noted, because of the dangerous effects of cancer treatment on bones, it’s essential that all cancer patients be tested for vitamin D deficiency. - SBL]
Source: Kealing J. Study: Joint pain ebbs with vitamin D. Reported via LJWorld.com. December 16, 2007.
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Survey: Nondrug Interventions for Cancer-Pain Relief
Oncology nurses are frequently responsible for the assessment and implementation of appropriate nondrug therapies used for adjuvant pain relief. Therefore, investigators at the University of Wisconsin surveyed a national sampling of 724 oncology-staff nurses regarding their use of and beliefs about 4 interventions: music, guided imagery, relaxation, and distraction.
Nurses reported using the 4 interventions at least ‘sometimes’ in these percentages: music 54%, guided imagery 40%, relaxation 82%, and distraction 80%. The use of the interventions depended on their perceived benefit to patients and the time involved. Additionally, the use of guided imagery depended on whether patients were considered by the nurses to have necessary cognitive abilities.
Practice Perspective: The investigators suggested that adjuvant pain relief strategies are necessary for adequate management of pain and it is important to select nondrug interventions that are well-suited to each patient. The implementation of the interventions studied may be improved through better staff education and the development of time-efficient delivery methods.
Reference: Kwekkeboom KL, Bumpus M, Wanta B, et al. Oncology nurses’ use of nondrug pain interventions in practice. J Pain Symptom Manage. 2007(Oct 22). Early online publication prior to print.
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Heat Wrap Effective for Lower Back Pain
Muscular pain may lead to increased muscle tension resulting in a tension-pain cycle. A randomized study in Germany assessed objective (electroencephalogram - EEG) and subjective (a 42-question self-assessment) effects of continuous low-level heat therapy in patients with low-back pain.
Patients (n = 30) were assigned to either continuous heat wrap therapy or a control group instructed to use nonsteroidal anti-inflammatory drugs as needed. The treatment group was allowed to use oral analgesics as rescue medication. The EEG results in the heat-therapy group showed a significant reduction in muscle tension, as compared with the control group. Additionally, the treatment group reported significant decreases in subjective measures of low-back pain, reduced daily stress, and improved sleep.
Practice Perspective: While this was a small study, other investigations have reported similar results using heat wraps. Therefore, this approach may offer a safe, effective, nondrug option for relief in appropriate patients with low-back pain. [A number of commercial products are available and can be found via Internet search on the terms “heat wrap.” - SBL.]
References: Kettenmann B, Wille C, Lurie-Luke E, et al. Impact of continuous low level heatwrap therapy in acute low back pain patients: subjective and objective measurements. Clin J Pain. 2007(Oct);23(8):663-668.
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First-Line Treatment Best for Acute Low-Back Pain
Australian researchers reporting in The Lancet investigated whether patients receiving recommended first-line care for acute low-back pain would recover faster with the addition of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or spinal manipulative therapy. Patients (n = 240) who had received baseline therapy - ie, physician advice and a prescription for paracetamol (acetaminophen) - were randomly assigned to 1 of 4 study groups:
- diclofenac 50 mg twice daily and spinal manipulative therapy (n = 60),
- diclofenac 50 mg twice daily and placebo manipulative therapy (n = 60),
- spinal manipulative therapy and placebo drug (n = 60), or
- double placebo (n = 60).
Diclofenac or spinal manipulative therapy, or both, did not significantly reduce the number of days until pain relief, compared with placebo. And, adding those interventions to baseline therapy failed to produce significant benefits for pain, disability, or global perceived effect at any of 4 measurement time points when they were added to baseline treatment. While 22 patients had possible medication adverse reactions, they were equally divided among the diclofenac and placebo-drug groups.
Clinical Implications: The researchers concluded that most patients receiving paracetamol (acetaminophen) and advice to “stay active” will recover as quickly as patients who also receive an NSAID and/or spinal manipulative therapy.
[Comment: This study sparked some discussion in health news publications. Physicians emphasized the importance of careful diagnosis and noted that the costs and side-effect risks of added treatments should be avoided if they are ineffective. Meanwhile, chiropractors claimed that the spinal manipulation techniques used in this study were primarily of the low-velocity mobilization type while, in contrast, previous studies showed effectiveness with higher velocity methods of manipulation.
For additional resources and guidance see the Pain-Topics.org “Low-Back Pain” section at: http://pain-topics.org/pain-disorders/index.php#LBP. - WD, SBL]
Reference: Hancock MJ, Maher CG, Latimer J, et al. Assessment of diclofenac or spinal manipulative therapy, or both, in addition to recommended first-line treatment for acute low back pain: a randomized controlled trial. The Lancet. 2007(Nov 10);370(9599):1638-1643.
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Special Edition of PMN Highlights Pain Therapies
In November 2007(Volume 5, Number 6), the publication Pain Medicine News released a Special Edition compendium of previously published educational reviews of importance. These are freely accessible to practitioners via the Internet and include the following:
- Addressing Sexual Impairment In Chronic Pain. By Diane Zelman, et al.
- Methadone: Unintended Mortality Due to Overdose and Arrhythmia. By Frederick Burgess, et al.
- New Treatments in the Management of Diabetic Peripheral Neuropathic Pain. By Louis Kuritzky, et al.
- Pain & Depression: Pathology, Prevalence, & Treatment. By Steven Stanos.
- Prevalence, Diagnosis, and Management of Fibromyalgia. By Kavita Gupta.
- Recent Advances in the Management of Chronic Low Back Pain. By Bill McCarberg and Gladstone McDowell.
- Three-Step Analgesic Ladder for Management of Cancer Pain. By Russell K. Portenoy.
 Access the articles at: http://painmedicinenews.com/index.asp?show=specialed (Free registration is required.)
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Exercise Relieves Pain of Fibromyalgia
Since the primary causes of fibromyalgia are unknown there is no single treatment for its symptoms. Investigators in Massachusetts compared the effectiveness of 4 common self-management treatment modalities on the symptoms, functionality, and self-efficacy in 207 women with confirmed fibromyalgia. Participants were randomly assigned to 16 weeks of either:
1) aerobic and flexibility exercise (AE),
2) strength training, aerobic, and flexibility exercise (ST),
3) the Fibromyalgia Self-Help Course (FSHC-only), or
4) a combination of ST and FSHC (ST-FSHC).
At 4 months, women in all exercise groups, including the exercise plus education group (ST-FSHC), reported less pain and fatigue -- and, there were 25% improvements in emotional health and functional ability. The ST-FSHC group showed the most significant amount of improvement, while the FSHC-only group improved the least. Women in exercise groups also reported improvements in self-efficacy.
Practice Pointers: The researchers noted that results of this study suggest that exercise and patient education are important adjuncts to any drug regimen for patients with fibromyalgia. Progressive walking, simple strength training activities, and stretching exercises can improve functional health, relieve symptoms, and improve self-efficacy.
It is noteworthy that the progress in physical function of participants in all groups that included exercise persisted at 6 months. However, about a third of participants did not complete the study, as has been reported in other similar studies.
Reference: Rooks DS, Gautam S, Romeling M, et al. Group exercise, education, and combination self-management in women with fibromyalgia: a randomized trial. Arch Intern Med. 2007(Nov 12);167(20):2192-2200.
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Laser Acupuncture May Relieve Child’s Headache Frequency
Researchers in Germany evaluated the effectiveness of laser acupuncture - a noninvasive, painless treatment using light energy at wavelengths that penetrate into soft tissues - in the treatment of headaches in children. This double-blind, placebo-controlled study randomized 43 children (mean age 12.3 years) with migraine (n = 22) or tension-type headache (n = 21) to the administration of 4 low-level laser acupuncture or placebo laser treatments during a 4-week period.
At 4 months after the study, a significant reduction in headache frequency was found for the acupuncture group (>6 fewer headache days per month vs only 1 day less in the placebo group). Laser-treated patients also demonstrated significant reductions in headache severity and total monthly hours with headache.
[Comment: This was a small study and low-level laser therapy is considered investigational by the US FDA. Licensed acupuncturists can provide the laser treatment as long as definitive medical claims regarding outcomes are not made and the regulations governing low-level lasers for investigational use are followed. It is always wise to consult with a potential practitioner regarding levels of experience with laser acupuncture, which requires knowledge beyond traditional acupuncture practices. -WD]
Reference: Gottschling S, Meyer S, Gribova I, et al. Laser acupuncture in children with headache: a double-blind, randomized, bicenter, placebo-controlled trial. Pain. 2007(Nov 15). Early online publication prior to print.
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Dextrose Injections Ease Pain of Achilles Tendinosis
Achilles tendinosis - ie, chronic tendinopathy with thickening and weakening of the tendon - can be difficult to manage because reduced circulation to the tissue impairs the potential for healing. Researchers in Vancouver, British Columbia, studied the pain-relieving effects of ultrasound-guided intratendinous injection of 25% hyperosmolar dextrose.
Injections were administered every 6 weeks to 36 patients with long-standing pain and were continued until patients were asymptomatic or failed to show improvement. The mean number of treatments was 4.0 (range, 2-11) and 33 tendons in 32 patients were treated successfully. Significant reductions were found for pain at rest, pain during normal daily activity, and pain during/after physical activity. Additionally, sonogram results showed a mean decrease in tendon thickness. Followup telephone interviews of 30 available patients (at 1-year post-treatment on average) showed that 20 of them continued to be asymptomatic, 9 experienced mild symptoms, and one patient had moderate symptoms.
Practice Perspective: The researchers concluded that the intratendinous injections of hyperosmolar dextrose exhibited good clinical results by providing 12-month pain relief for more than half of this patient population with chronic tendinosis of the achilles tendon.
Reference: Maxwell NJ, Ryan MB, Taunton JE, et al. Sonographically guided intratendinous injection of hyperosmolar dextrose to treat chronic tendinosis of the achilles tendon: a pilot study. AJR Am J Roentgenol. 2007(Oct);189(4):W215-W220.
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Insomnia Reduces Quality of Life in Youngsters with Limb Pain
An evaluation of insomnia as a cause of reduced quality of life in pediatric limb pain was published in the December issue of the Journal of Rheumatology. Researchers recruited 74 rheumatology-clinic patients 3 to 18 years of age who were being evaluated for limb pain. Parents were asked to complete a pediatric sleep questionnaire and a pediatric quality of life inventory; children were asked to complete the same inventories and/or validate measures of pain duration and current pain levels, as appropriate.
Insomnia was considered substantial if a child had 2 or more of the following symptoms: difficulty falling asleep at night, waking more than twice (on average), difficulty falling back to sleep, or feeling unrefreshed upon awakening. More than half of the patients (54%) met criteria for insomnia. Furthermore, insomnia, but not pain level or duration, significantly influenced low quality of life scores.
Clinical Conclusion: It would appear that insomnia in young patients with limb pain is a major factor negatively affecting their lives, possibly more so than pain itself. Therefore, insomnia would merit adequate assessment and treatment in this population.
Reference: LaPlant MM, Adams BS, Haftel HM, Chervin RD. Insomnia and quality of life in children referred for limb pain. J Rheumatol. 2007(Dec);34(12):2486-2490.
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Cryoablation Reduces Metastatic Bone Pain
Because metastatic bone pain often requires long-term treatment, researchers at the Mayo Clinic evaluated image-guided cryoablation (the process of destroying abnormal cells by freezing) for pain relief in patients with a wide range of primary cancers — including renal cell, bronchogenic, colorectal, ovarian, thyroid, and melanoma - that had metastasized to bone.
One or more cryoprobes were guided by computed tomography to treat 34 patients with a single freeze-thaw-freeze cycle. Prior to treatment the average score for “worst pain” in a 24-hour period was about 7 (range 4-10), and this significantly decreased by a mean 4.3, 3.5, and 1.7 points at 4, 8, and 24 weeks post-treatment, respectively. Most patients also reported a decrease in oral analgesic use, and no complications were reported.
Clinical Context: This small study demonstrated that percutaneous cryoablation appears to be a safe, palliative treatment that provides significant pain reduction during a 6-month period. In a related story (Science Daily), Matthew Callstrom, MD, PhD, stated that, with the aid of a grant from the National Cancer Institute, he plans to lead a nationwide, randomized study in a similar population of patients to compare cryoablation against radiation (currently the most common approach to manage localized metastatic bone pain).
Reference: Callstrom M, Atwell T, Charboneau JW, et al. Image-guided cryoablation of painful metastatic disease involving bone: ongoing clinical trial. Radiological Society of North America annual meeting, Chicago. November 25-30, 2007. Abstract VI31-13
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Pregabalin Effective for Trigeminal Neuralgia
Trigeminal neuralgia -- pain originating in the 2nd or 3rd divisions of the trigeminal nerve serving the cheek and/or chin -- frequently inflicts short bursts of severe pain over a dull background pain. A study in Germany evaluated the effectiveness of pregabalin (Lyrica®) in 53 patients with this condition.
Patients received pregabalin 150-600 mg daily and were followed for 1 year. Almost 75% of them improved after 8 weeks with an average pregabalin dose of about 270 mg/day (range 150-600 mg/day). Complete pain relief was reported by about 25% of participants and roughly half reported pain reduction of greater than 50%. Of the 13 patients who were pain-free at 8 weeks, 11 remained so at 1 year.
Clinical Implications: The investigators concluded that pregabalin appeared to be effective for the pain management of trigeminal neuralgia; however, in a subgroup of patients with chronic facial pain this treatment was less successful.
Reference: Obermann M, Yoon MS, Sensen K, et al. Efficacy of pregabalin in the treatment of trigeminal neuralgia. Cephalalgia. 2007(Nov 26); Early online publication prior to print.
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Recent Drug or Device Approvals and Announcements
Following are briefs on new pain-management drug or device approvals or announcements, as well as items related to safety concerns for existing products. If the FDA or DEA news website posted a specific announcement, the link to it has been provided below. All brand names are registered trademarks of their respective manufacturers.
Fentanyl (patch) - FDA Safety Alert
FDA issued an update highlighting important information on appropriate prescribing, dose selection, and the safe use of the fentanyl transdermal system (patch, marketed as Duragesic® and generics). FDA previously issued notices; however, the Agency continues to receive reports of death and life-threatening adverse events related to fentanyl overdose that have occurred when the patch was used to treat pain in opioid-naive patients and when opioid-tolerant patients have applied more patches than prescribed, changed the patch too frequently, and exposed the patch to a heat source. The fentanyl patch is only indicated for use in patients with persistent, moderate to severe chronic pain who have been taking a regular, daily, around-the-clock narcotic pain medicine for longer than a week and are considered to be opioid-tolerant. Patients must avoid exposing the patch to excessive heat (including during a hot shower or bath) as this promotes the release of fentanyl from the patch and increases the absorption of the drug through the skin which can result in fatal overdose. Directions for prescribing and using the fentanyl patch must be followed exactly to prevent death or other serious side effects from overdose.
DEA Advisory - Methadone 40 mg Tablets Restricted
As of January 1, 2008, manufacturers of methadone hydrochloride tablets 40 mg (dispersible) have voluntarily agreed to restrict distribution of this formulation to only those facilities authorized for detoxification and maintenance treatment of opioid addiction, and to hospitals. The 5 mg and 10 mg formulations indicated for the treatment of pain will continue to be available to all authorized registrants, including retail pharmacies. The 40 mg strength was never FDA approved for use in pain management.
Voltaren® Gel - Newly Approved Topical Pain Reliever
The FDA granted an October approval of topical Voltaren® Gel (diclofenac sodium) 1%, a nonsteroidal anti-inflammatory medication (NSAID) for the treatment of joint pain associated with osteoarthritis. This is the first topical NSAID prescription medication approved for osteoarthritis pain and is presumed to be less likely to cause the side affects associated with oral NSAIDs. The approvals were based on Novartis-sponsored trials demonstrating a 42% decrease in hand pain after 4 weeks and a 50% reduction in knee pain after 12 weeks of use. The most commonly reported adverse effect was dermatitis at the site of application. It is important to note that the gel should not be used concurrently with oral NSAIDs.
DEA Finalizes Multiple Prescription Rule for Opioids
The Drug Enforcement Administration (DEA) has agreed to a ruling allowing practitioners to write multiple prescriptions for schedule-II substances when it is appropriate. The November DEA ruling became effective on December 19, 2007 and allows practitioners to write up to 3 separate 30-day prescriptions for the same opioid medication - with staggered fill dates. This will allow a patient with chronic pain to receive 90 days worth of prescriptions without having to make an appointment each month for a renewal.
Omeprazole (Prilosec®) and Esomeprazole (Nexium®) - FDA Safety Analysis
As a follow-up to an August FDA notice on concerns regarding the safety of omeprazole and esomeprazole, the FDA has completed a comprehensive review of the data from the 2 studies submitted for evaluation. These products are used in the management of heartburn pain due to gastroesophageal reflux disease and the FDA has concluded that these products are not likely to be associated with an increased risk of heart problems with long-term use.
Carbamazepine (Tegretol®) - FDA Safety Warning
Carbamazepine, an anticonvulsant, also is approved to relieve the pain of trigeminal neuralgia and glossopharyngeal neuralgia. The FDA has informed healthcare professionals that disabling, even fatal, skin reactions can result from carbamazepine therapy and are significantly more common in patients with a specific human leukocyte antigen (HLA) allele, HLA-B*1502. The allele is found almost exclusively in people of Asian ancestry, including South Asian Indians. Patients from these regions (including mixed nationalities) should be screened for the HLA-B*1502 allele before beginning carbamazepine therapy, and a careful risk-benefit analysis should be done for any patient who tests positive. Specific risks are for Stevens-Johnson syndrome and toxic epidermal necrolysis, both of which cause serious blistering reactions of the skin and mucous membranes. Patients who are at high risk for reaction will experience symptoms within the first few months of treatment 90% of the time.
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