Opioid Reduction Following Spinal Cord Stimulation: A Comparison of Two Protocols, Effect on Patient Quality of Life and Cost-Impact to the Healthcare System

The Neuromodulation clinic in the Regina Qu'Appelle Health Region currently provides service to 501 patients with 266 of those being spinal cord stimulation (SCS) cases. There is an average of 30 new SCS cases per year with the majority of those being implanted for unilateral or bilateral leg pain with or without low back pain. All patients are done via a two-step process consisting of an initial trial with an externalized electrode for a 1-2 week trial period. At the end of the trial period, if successful, the patient undergoes the internalization procedure. Our goal during the trial period is to achieve a pain reduction of 50% or more. Our mean success rates for trial to implant are approximately 80%. After the internalization procedure, patients are instructed to slowly begin weaning their pain medications.

There is scant data discussing the effect of SCS systems on medication use and particularly, opioids. To date, pain medication weaning has been largely left to the discretion of the patient with no formalized system for oversight. This has resulted in poor rates of reduction of opioid consumption in spite of improved pain relief achieved with SCS. In addition, should a patient have a successful SCS trial and move on to the permanent implant, how do we break them of their dependence on opioids? Some patients have a good relationship with their family physician and will rely on him/her to help wean them off the opioids. Others feel that they can manage weaning on their own (self-management). As intensity of pain improves along with quality of life, pain medication consumption should decrease in tandem without jeopardizing pain control. However, a lack of adherence by the patient or family physician would interfere with this process. The current standard of care is for the patient and their family physician to decide the best weaning process. The investigators propose that having a multidisciplinary Neuromodulation team with a dedicated pharmacist who can draw up a patient specific weaning schedule and follow the patient closely would more effectively reduce opioid consumption than patient (self-management) or family physician-aided weaning alone

Importance of this Study Chronic pain is estimated to cost the Canadian health care system $6 billion per year according to the Canadian Pain Society with this number expected to continue to rise. SCS systems have been proven to be more cost effective than conventional medical management for chronic pain patients. Increased use of SCS systems would help to decrease the burden on our health care dollars. In addition, the added risk of long term opioid use leads to issues of tolerance, physical dependence and potential adverse effects including overdose. Social concerns regarding opioid divergence and inappropriate use must also be taken into account. The goal for this project is to further strengthen the support for the use of SCS and provide information on the most effective way to decrease opioid use among the chronic pain population.

Research Purpose and Objectives:

The primary purpose of this study is to compare opioid use post-SCS implant at 1, 3, 6, 9 and 12 month intervals in patients who were provided with a weaning schedule by the Neuromodulation team (experimental group) versus those who wean on their own or with their family doctor (control group; standard care) to determine if one strategy is superior to the other.