Pharmacological Interventions Including Medical Injections for Neck Pain: An Overview as Part of the ICON Project.

OBJECTIVES: To conduct an overview (review-of-reviews) on pharmacological interventions for neck pain. SEARCH STRATEGY: Computerized databases and grey literature were searched from 2006 to 2012. SELECTION CRITERIA: Systematic reviews of randomized controlled trials (RCT) in adults with acute to chronic neck pain reporting effects of pharmacological interventions including injections on pain, function/disability, global perceived effect, quality of life and patient satisfaction. DATA COLLECTION & ANALYSIS: Two independent authors selected articles, assessed risk of bias and extracted data The GRADE tool was used to evaluate the body of evidence and an external panel provided critical review. MAIN RESULTS: We found 26 reviews reporting on 47 RCTs. Most pharmacological interventions had low to very low quality methodologic evidence with three exceptions. For chronic neck pain, there was evidence of: a small immediate benefit for eperison hydrochloride (moderate GRADE, 1 trial, 157 participants);no short-term pain relieving benefit for botulinum toxin-A compared to saline (strong GRADE; 5 trial meta-analysis, 258 participants) nor for subacute/chronic whiplash (moderate GRADE; 4 trial meta-analysis, 183 participants) including reduced pain, disability or global perceived effect; andno long-term benefit for medial branch block of facet joints with steroids (moderate GRADE; 1 trial, 120 participants) over placebo to reduce pain or disability; REVIEWERS' CONCLUSIONS: While in general there is a lack of evidence for most pharmacological interventions, current evidence is against botulinum toxin-A for chronic neck pain or subacute/chronic whiplash; against medial branch block with steroids for chronic facet joint pain; but in favour of the muscle relaxant eperison hydrochloride for chronic neck pain.

A systematic review and meta-analysis of efficacy, cost-effectiveness, and safety of selected complementary and alternative medicine for neck and low-back pain.

Background. Back pain is a common problem and a major cause of disability and health care utilization. Purpose. To evaluate the efficacy, harms, and costs of the most common CAM treatments (acupuncture, massage, spinal manipulation, and mobilization) for neck/low-back pain. Data Sources. Records without language restriction from various databases up to February 2010. Data Extraction. The efficacy outcomes of interest were pain intensity and disability. Data Synthesis. Reports of 147 randomized trials and 5 nonrandomized studies were included. CAM treatments were more effective in reducing pain and disability compared to no treatment, physical therapy (exercise and/or electrotherapy) or usual care immediately or at short-term follow-up. Trials that applied sham-acupuncture tended towards statistically nonsignificant results. In several studies, acupuncture caused bleeding on the site of application, and manipulation and massage caused pain episodes of mild and transient nature. Conclusions. CAM treatments were significantly more efficacious than no treatment, placebo, physical therapy, or usual care in reducing pain immediately or at short-term after treatment. CAM therapies did not significantly reduce disability compared to sham. None of the CAM treatments was shown systematically as superior to one another. More efforts are needed to improve the conduct and reporting of studies of CAM treatments.

Standardization of adverse event terminology and reporting in orthopaedic physical therapy: application to the cervical spine.

SYNOPSIS: Orthopaedic physical therapy is considered safe, based on a lack of reported harms. Most of the research until now has focused on benefits. Consideration of benefits and harm involves informed consent, clinical decision making, and cost-benefit analyses. Benefits and harms are treatment and dosage specific. There is currently an insufficient number of dosage trials in orthopaedic physical therapy to identify optimal dosage for common interventions, including exercise and manual therapy. Published cases of severe adverse events following chiropractic manipulation illustrate the need for physical therapy to have high-quality data documenting the safety of orthopaedic physical therapy, including cervical manipulation. A recent systematic review identified poor reporting standards of harms within clinical research in this area. Lack of standardization of terminology has contributed to this problem. Pharmacovigilence provides a framework for terms that orthopaedic physical therapy can adapt and thereafter adopt into clinical practice and research. Adverse events are unexpected events that occur following an intervention without evidence of causality. Where temporality of an event is highly suggestive of causality, the term "adverse reaction" may be more appropriate. Future studies in orthopaedic physical therapy should adopt the CONSORT statement extension on the reporting of harms, published in 2004, to ensure better reporting. Consistent reporting of harms in both research and clinical practice requires professional consensus on terminology pertaining to harms, as well as defining what constitutes an adverse event or an adverse reaction. Widespread consultation and consensus should support optimal definitions and processes and facilitate their implementation into practice. This paper is focused on theoretical considerations and evidence in terms of harm reporting within physical therapy using cervical manual therapy as an example.

Complementary and alternative therapies for back pain II.

BACKGROUND: Back and neck pain are important health problems with serious societal and economic implications. Conventional treatments have been shown to have limited benefit in improving patient outcomes. Complementary and Alternative Medicine (CAM) therapies offer additional options in the management of low back and neck pain. Many trials evaluating CAM therapies have poor quality and inconsistent results. OBJECTIVES: To systematically review the efficacy, effectiveness, cost-effectiveness, and harms of acupuncture, spinal manipulation, mobilization, and massage techniques in management of back, neck, and/or thoracic pain. DATA SOURCES: MEDLINE, Cochrane Central, Cochrane Database of Systematic Reviews, CINAHL, and EMBASE were searched up to 2010; unpublished literature and reference lists of relevant articles were also searched. study selection: All records were screened by two independent reviewers. Primary reports of comparative efficacy, effectiveness, harms, and/or economic evaluations from randomized controlled trials (RCTs) of the CAM therapies in adults (age ≥ 18 years) with back, neck, or thoracic pain were eligible. Non-randomized controlled trials and observational studies (case-control, cohort, cross-sectional) comparing harms were also included. Reviews, case reports, editorials, commentaries or letters were excluded. DATA EXTRACTION: Two independent reviewers using a predefined form extracted data on study, participants, treatments, and outcome characteristics. RESULTS: 265 RCTs and 5 non-RCTs were included. Acupuncture for chronic nonspecific low back pain was associated with significantly lower pain intensity than placebo but only immediately post-treatment (VAS: -0.59, 95 percent CI: -0.93, -0.25). However, acupuncture was not different from placebo in post-treatment disability, pain medication intake, or global improvement in chronic nonspecific low back pain. Acupuncture did not differ from sham-acupuncture in reducing chronic non-specific neck pain immediately after treatment (VAS: 0.24, 95 percent CI: -1.20, 0.73). Acupuncture was superior to no treatment in improving pain intensity (VAS: -1.19, 95 percent CI: 95 percent CI: -2.17, -0.21), disability (PDI), functioning (HFAQ), well-being (SF-36), and range of mobility (extension, flexion), immediately after the treatment. In general, trials that applied sham-acupuncture tended to produce negative results (i.e., statistically non-significant) compared to trials that applied other types of placebo (e.g., TENS, medication, laser). Results regarding comparisons with other active treatments (pain medication, mobilization, laser therapy) were less consistent Acupuncture was more cost-effective compared to usual care or no treatment for patients with chronic back pain. For both low back and neck pain, manipulation was significantly better than placebo or no treatment in reducing pain immediately or short-term after the end of treatment. Manipulation was also better than acupuncture in improving pain and function in chronic nonspecific low back pain. Results from studies comparing manipulation to massage, medication, or physiotherapy were inconsistent, either in favor of manipulation or indicating no significant difference between the two treatments. Findings of studies regarding costs of manipulation relative to other therapies were inconsistent. Mobilization was superior to no treatment but not different from placebo in reducing low back pain or spinal flexibility after the treatment. Mobilization was better than physiotherapy in reducing low back pain (VAS: -0.50, 95 percent CI: -0.70, -0.30) and disability (Oswestry: -4.93, 95 percent CI: -5.91, -3.96). In subjects with acute or subacute neck pain, mobilization compared to placebo significantly reduced neck pain. Mobilization and placebo did not differ in subjects with chronic neck pain. Massage was superior to placebo or no treatment in reducing pain and disability only amongst subjects with acute/sub-acute low back pain. Massage was also significantly better than physical therapy in improving back pain (VAS: -2.11, 95 percent CI: -3.15, -1.07) or disability. For subjects with neck pain, massage was better than no treatment, placebo, or exercise in improving pain or disability, but not neck flexibility. Some evidence indicated higher costs for massage use compared to general practitioner care for low back pain. Reporting of harms in RCTs was poor and inconsistent. Subjects receiving CAM therapies reported soreness or bleeding on the site of application after acupuncture and worsening of pain after manipulation or massage. In two case-control studies cervical manipulation was shown to be significantly associated with vertebral artery dissection or vertebrobasilar vascular accident. CONCLUSIONS: Evidence was of poor to moderate grade and most of it pertained to chronic nonspecific pain, making it difficult to draw more definitive conclusions regarding benefits and harms of CAM therapies in subjects with acute/subacute, mixed, or unknown duration of pain. The benefit of CAM treatments was mostly evident immediately or shortly after the end of the treatment and then faded with time. Very few studies reported long-term outcomes. There was insufficient data to explore subgroup effects. The trial results were inconsistent due probably to methodological and clinical diversity, thereby limiting the extent of quantitative synthesis and complicating interpretation of trial results. Strong efforts are warranted to improve the conduct methodology and reporting quality of primary studies of CAM therapies. Future well powered head to head comparisons of CAM treatments and trials comparing CAM to widely used active treatments that report on all clinically relevant outcomes are needed to draw better conclusions.

Knowledge to action: a challenge for neck pain treatment.

SYNOPSIS: For clinicians, systematic reviews can enhance incorporation into practice of the large volumes of information emerging from research on effectiveness and risks. But we believe that these reviews are most useful with simplified tools to facilitate translation of this knowledge into practice. We provide a "Neck Care Tool Kit" that gives a diagrammatic approach to prioritizing intervention. The evidence from a series of 11 systematic reviews by the Cervical Overview Group is depicted in decision flow-charts and tables to enhance clinical interpretation of the overview findings. On simple visual inspection of symbols in a table, the reader can establish where there is evidence of benefit or no benefit, the strength of the recommendation, and if these data represent short- or long-term findings. Where possible, we guide clinicians to dosage of specific treatment methods. There is no consensus as to which outcome measures to prioritize among the large number in use. This clinical commentary guides clinicians to view the evidence in enough detail to integrate it into their clinical practice environment. We conclude by delineating research gaps and proposing future research directions. LEVEL OF EVIDENCE: Therapy, level 5.

Understanding the influence of the complex relationships among informal and formal supports on the well-being of caregivers of persons with dementia.

This study examined the direct and indirect relationships between caring for a person with dementia and caregiver health. A conceptual model of the caregiver stress process considered informal caregiver characteristics, sources of caregiver stress, and the influence of informal and formal support on the well-being of the caregivers of persons with dementia. Structural equation modeling was used to test specific hypotheses in a sample of 327 caregivers of people with dementia who were living in the community, as part of the first wave of the Canadian Study of Health and Aging. Our findings show that the negative impact of the increasing disability of the care recipient on the psychological well-being of the caregiver was mediated mostly by the use of informal support systems and marginally by the use of formal support systems. The use of informal support by caregivers was associated with a decreased use of formal supports. The relationship between caregiver characteristics and their psychological health was mediated by the use of formal support but not by the use of informal support systems.