Spinal Cord Stimulator Implant Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pain Coping Skills Training for Spinal Cord Stimulator Implant Candidates

Conditions
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Back Pain

Intervention / Treatment
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* Behavioral: Coping Skills Training
* Behavioral: Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria daily back pain for 6 months or more approved by physician and psychologist for implant ability to read and write English at least 18 years old Exclusion Criteria: pending litigation not approved for implant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coping Skills Training<br>Coping Skills Training in pain management | Behavioral: Coping Skills Training<br>* Patients meet individually with therapist for 6 sessions to learn coping skills for stress management, behavioral activation, and communication.<br>|
| Active Comparator: Education<br>Chronic Pain Education | Behavioral: Education<br>* 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.<br>|
| No Intervention: Usual Care<br>Patients receive no study intervention, continue with usual medical care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvements in pain, psychological distress, and physical disability | Improvements in pain, psychological distress, and physical disability Pre-intervention, post-intervention, 6 month, and 12 month follow-ups | Pre-intervention, post-intervention, 6 month, and 12 month follow-ups | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients will learn a repertoire of coping skills which can be applied to other challenges in life. | Patients will learn a repertoire of coping skills which can be applied to other challenges in Pre-intervention, post intervention, 6 month, and 12 month follow-upslife. | Pre-intervention, post intervention, 6 month, and 12 month follow-ups | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic back pain, spinal cord stimulator implant