Spinal Cord Stimulator Implant Study — SCS  

Back Pain Clinical Trial

Official title: Pain Coping Skills Training for Spinal Cord Stimulator Implant Candidates

Status Completed

Clinical Trial Summary

This study is for patients who have been approved by their doctors and insurance companies to receive spinal cord stimulator implants.

The goal of this study is to investigate if pain and disability is improved in patients with an implant in combination with coping skills training. These patients are compared with those with an implant that receive chronic education information and those with an implant that are in the control group and receive no additional training or information.

Clinical Trial Description

This study tests the hypotheses that a pain coping skills program in combination with an SCS implant can improve short- and long-term outcomes in self-efficacy for coping with chronic pain, physical disability, psychological distress, and pain intensity.

Participants are patients who have been approved by their doctors and insurance companies to receive the spinal cord stimulator trial. After patients have been approved, they can be enrolled in this study. After completing a baseline evaluation, patients are randomized into (1)six individual pain coping skills training sessions(relaxations techniques, communication skills, goal setting), (2) six individual chronic pain education sessions (discussion approach to etiology and treatment of chronic pain and information on spinal cord stimulator implants, or (3) treatment as usual (no study intervention).

Participants are evaluated prior to or shortly after their surgery, at post treatment, at 6 month follow-up and at 12 month follow-up. All participants continue their routine medical care throughout the study. ;

Related Conditions & MeSH terms

• Back Pain

• NCT number: NCT00887419
• Study type: Interventional
• Source: Duke University
• Status: Completed
• Phase: N/A
• Start date: November 2008
• Completion date: December 2014