Assessment of methodologic quality of randomized trials of interventional techniques: development of an interventional pain management specific instrument.

BACKGROUND: A major component of a systematic review is an assessment of the methodological quality and bias of randomized trials. The most commonly utilized methodological quality assessment and bias assessment for randomized trials is by the Cochrane Review Group. While this is not a "gold standard," it is an indication of the current state-of-the-art review methodology. There is, however, no specific instrument to assess the methodological quality of manuscripts published for interventional techniques. OBJECTIVES: Our objective was to develop an instrument specifically for interventional pain management, to assess the methodological quality of randomized trials of interventional techniques. METHODS: Item generation for the instrument was based on a definition of quality, to the extent to which the design and conduct of the trial were congruent with the objectives of the trial. Applicability was defined as the extent to which the trial produced procedures could be applied with contemporary interventional pain management techniques. Multiple items based on Cochrane review criteria were utilized along with specific requirements for interventional techniques. RESULTS: A total of 22 items were developed which formed IPM-QRB or Interventional Pain Management Techniques - Quality Appraisal of Reliability and Risk of Bias Assessment tool. This included 9 of the 12 items from the Cochrane review criteria with definition of some items that were repetitive or duplicate, and the addition of 13 new items. The results were compared for inter-rater reliability of Cochrane review criteria and IPM-QRB, and inter-instrument reliability. The assessment was performed in multiple stages with an initial learning curve. The final assessment was for 4 randomized controlled trials (RCTs) utilizing both Cochrane review criteria and IPM-QRB criteria. The inter-rater agreement for Cochrane review criteria with overall intra-class correlation coefficient was 0.407 compared to an intra-class correlation coefficient of 0.833 for IPM-QRB criteria. The inter-rater agreement was superior for IPM-QRB criteria compared to Cochrane review criteria despite twice the items of Cochrane review criteria as IPM-QRB criteria with the detailed nature of assessment. LIMITATIONS: Limited validity or accuracy assessment of the instrument and the large number of items to be scored. CONCLUSION: We have developed a new comprehensive instrument to assess the methodological quality of randomized trials of interventional techniques. This instrument is superior to Cochrane review methodology criteria in that it provides more extensive and specific information for interventional techniques that will be useful in assessing the methodologic quality and bias of interventional techniques.

Development of an interventional pain management specific instrument for methodologic quality assessment of nonrandomized studies of interventional techniques.

BACKGROUND: The major component of a systematic review is assessment of the methodologic quality and bias of randomized and nonrandomized trials. While there are multiple instruments available to assess the methodologic quality and bias for randomized controlled trials (RCTs), there is a lack of extensively utilized instruments for observational studies, specifically for interventional pain management (IPM) techniques. Even Cochrane review criteria for randomized trials is considered not to be a "gold standard," but merely an indication of the current state of the art review methodology. Recently a specific instrument to assess the methodologic quality of randomized trials has been developed for interventional techniques. OBJECTIVES: Our objective was to develop an IPM specific instrument to assess the methodological quality of nonrandomized trials or observational studies of interventional techniques. METHODS: The item generation for the instrument was based on a definition of quality, to the extent to which the design and conduct of the trial were congruent with the objectives of the study. Applicability was defined as the extent to which procedures produced by the study could be applied using contemporary IPM techniques. Multiple items based on Cochrane review criteria and Interventional Pain Management Techniques - Quality Appraisal of Reliability and Risk of Bias Assessment for Nonrandomized Studies (IPM-QRBNR) were utilized. RESULTS: A total of 16 items were developed which formed the IPM-QRBNR tool. The assessment was performed in multiple stages. The final assessment was 4 nonrandomized studies. The inter-rater agreement was moderate to good for IPM-QRBNR criteria. LIMITATIONS: Limited validity or accuracy assessment of the instrument and the large number of items to be scored were limitations. CONCLUSION: We have developed a new comprehensive instrument to assess the methodological quality of nonrandomized studies of interventional techniques. This instrument provides extensive information specific to interventional techniques is useful in assessing the methodological quality and bias of observational studies of interventional techniques.

The story of the Texas Pain Society: formation and function of a regional pain society.

The idea of forming a Texas Pain Society came to the Founders in 1987 due to disparity and deficiencies in the practice of pain management in the United States and, in particular, the State of Texas. The Founders considered very carefully the implication of forming such a society. They diligently mapped out the mission and goals of the Texas Pain Society in those early formative years. This report is the history of Texas Pain Society as the activities unfolded from 1989 to 2011. The reader may question why there is a need to tell such a story. We believe strongly that, with disparities of standards of practice in pain medicine and poor recognition of advances in pain management, this scenario is quite common in many states and countries. The practitioners of pain management in these regions certainly must have considered getting together and forming a consensus on the standards of practice in their communities. This historical report of the Texas Pain Society provides the relevant information necessary and the efforts to be made for a society's mission to achieve its goals and have an ongoing impact in its own region. We hope that we have shed some light on a process for the formation of a regional pain society such as ours.

Intervertebral disc: anatomy-physiology-pathophysiology-treatment.

This review article describes anatomy, physiology, pathophysiology and treatment of intervertebral disc. The intervertebral discs lie between the vertebral bodies, linking them together. The components of the disc are nucleus pulposus, annulus fibrosus and cartilagenous end-plates. The blood supply to the disc is only to the cartilagenous end-plates. The nerve supply is basically through the sinovertebral nerve. Biochemically, the important constituents of the disc are collagen fibers, elastin fibers and aggrecan. As the disc ages, degeneration occurs, osmotic pressure is lost in the nucleus, dehydration occurs, and the disc loses its height. During these changes, nociceptive nuclear material tracks and leaks through the outer rim of the annulus. This is the main source of discogenic pain. While this is occurring, the degenerative disc, having lost its height, effects the structures close by, such as ligamentum flavum, facet joints, and the shape of the neural foramina. This is the main cause of spinal stenosis and radicular pain due to the disc degeneration in the aged populations. Diagnosis is done by a strict protocol and treatment options are described in this review. The rationale for new therapies are to substitute the biochemical constituents, or augment nucleus pulposus or regenerate cartilaginous end-plate or finally artificial disc implantation..

Evolution of interventional techniques.

Regional anesthesia techniques are used in pain treatment for more than a century. Although its use for acute pain conditions, such as intraoperative, postoperative and traumatic pain, is very well accepted, its use for the chronic pain syndromes is still lacking a consensus among the practitioners. The interventional techniques, which are mostly originated from the regional anesthetic techniques, have gained an increasing interest for the treatment of chronic pain syndromes during the last few decades. In this review, the development and clinical aspects of epidural injections, epiduroscopy, facet denervaion, intradiscal applications, vertebroplasty, sympathetic neurolysis, and central and peripheral continuous infusion techniques are discussed.

Botulinum toxin therapy in pain management.

BTs seem to be a useful treatment in refractory MPS and headache. Presumably BTs work by breaking the spasm or pain cycle giving the patient a "window of opportunity" for traditional conservative measures to have a greater beneficial impact, but several studies suggest that a direct antinociceptive effect distinct from any reduction in muscle spasm may be at play. The major benefit of BTs compared with standard therapies is duration of response. We do not advocate that BTs be used as a first line treatment for MPS or headache. However, in refractory cases where nothing else has worked, it may offer a chance for improvement or cure not otherwise available. For now, it remains an off label, but increasingly accepted, approach in-patients with refractory myofascial pain and headache, who despite multidisciplinary approaches, continue to suffer.

An updated interdisciplinary clinical pathway for CRPS: report of an expert panel.

The goal of treatment in patients with complex regional pain syndrome (CRPS) is to improve function, relieve pain, and achieve remission. Current guidelines recommend interdisciplinary management, emphasizing 3 core treatment elements: pain management, rehabilitation, and psychological therapy. Although the best therapeutic regimen or the ideal progression through these modalities has not yet been established, increasing evidence suggests that some cases are refractory to conservative measures and require flexible application of the various treatments as well as earlier consideration of interventions such as spinal cord stimulation (SCS). While existing treatment guidelines have attempted to address the comprehensive management of CRPS, all fail to provide guidance for contingent management in response to a sudden change in the patient's medical status. This paper reviews the current pathophysiology as it is known, reviews the purported treatments, and provides a modified clinical pathway (guideline) that attempts to expand the scope of previous guidelines.