Spinal Cord Stimulator Implant Study (SCS)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pain Coping Skills Training for Spinal Cord Stimulator Implant Candidates|
- Improvements in pain, psychological distress, and physical disability [ Time Frame: Pre-intervention, post-intervention, 6 month, and 12 month follow-ups ] [ Designated as safety issue: No ]
- Patients will learn a repertoire of coping skills which can be applied to other challenges in life. [ Time Frame: Pre-intervention, post intervention, 6 month, and 12 month follow-ups ] [ Designated as safety issue: No ]
|Study Start Date:||November 2008|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Coping Skills Training
Coping Skills Training in pain management
Behavioral: Coping Skills Training
Patients meet individually with therapist for 6 sessions to learn coping skills for stress management, behavioral activation, and communication.
Active Comparator: Education
Chronic Pain Education
Patients meet individually with a health educator for 6 sessions in a presentation/discussion format to receive basic information on the etiology and treatment of chronic pain.
No Intervention: Usual Care
Patients receive no study intervention, continue with usual medical care.
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.
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Laura Porter, Ph.D.||Duke University|