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.

Alternative approach to needle placement in cervical spinal cord stimulator insertion.

BACKGROUND: Neuromodulation with spinal cord stimulation is a proven cost effective treatment for the management of common conditions such as chronic radicular leg pain from failed back surgery syndrome, complex regional pain syndrome, and other painful neuropathic pain syndromes. The traditionally instructed method for percutaneous spinal cord stimulator (SCS) lead placement promotes the use of a "loss of resistance" (LOR) technique under anteroposterior (AP) fluoroscopic guidance to assure midline lead placement and proper entry into the epidural space. OBJECTIVE: To describe the relevant anatomy and method for a precise needle placement approach for placement of percutaneous cervical spinal cord stimulation (SCS) leads without loss of resistance (LOR) using a syringe. An oblique fluoroscopic view is presented demonstrating successful placement of cervical SCS leads. DESIGN: Technical report. SETTING: Pain management clinic. METHODS: Discussion with accompanying fluoroscopic images. This technical report meets HIPAA compliance standards. RESULTS: Successful placement of percutaneous SCS leads without traditional loss of resistance using an oblique fluoroscopic approach. LIMITATIONS: Technical report only. The risks, potential complications, and benefit from this approach are beyond the scope of the article. CONCLUSIONS: This fluoroscopic technique provides an alternative means for placing percutaneous cervical SCS leads without the use of the traditional loss of resistance technique.

Alternative approach to needle placement in spinal cord stimulator trial/implantation.

Neuromodulation with spinal cord stimulation is a proven, cost effective treatment for the management of chronic radicular low back pain from failed low back surgery syndrome and other neuropathic pain conditions. The traditionally instructed method for percutaneous spinal cord stimulator lead placement promotes the use of a "loss of resistance" technique under anteroposterior fluoroscopic guidance to assure midline lead placement and proper entry into the epidural space. Loss of resistance is a reliable method to locate the epidural space in most clinical situations. However, in certain circumstances such as a congenital underdeveloped ligamentum flavum or defects of the ligamentum flavum, sometimes occurring after lumbar spine surgery, it might become difficult to use a loss of resistance technique to locate the epidural space. In this case, the level of resistance might not be clear. Further, a false loss of resistance might occur between changes in fascial planes that might lead to the uncertainty of needle depth. This paper introduces an alternative method for needle placement for spinal cord stimulator (SCS) trials and implantation without using the traditional loss of resistance technique. The technique allows for precise visual monitoring of the Tuohy needle tip under fluoroscopy to gauge needle depth as it enters into the tissue and the epidural space based on anatomic structural landmarks. This method allows for multiple lead placement or single lead insertion multiple times in the same interlaminar space. This is an alternative approach to the loss of resistance technique based on the fluoroscopic landmarks. Theoretically, this should be a safer approach for accessing the epidural space; however, further studies are needed to evaluate its safety.

Cervical nerve root stimulation: demonstration of an extra-foraminal technique.

Since the description of electrical stimulation of nerve trunks as a means of providing pain relief, innovative peripheral nerve and nerve root stimulations have been developed. An extra-foraminal technique of electrical stimulation of cervical nerve roots resulting in reduction of upper extremity radicular pain is demonstrated here. Electrical stimulation of the C6 and C7 nerve roots was accomplished using a four-electrode spinal cord stimulator lead that was placed percutaneously within the exit zone of the neuroforamina using an extra-foraminal approach. Subsequent C6 and C7 nerve root stimulation provided a reduction in arm pain within the distribution of the stimulation.