Spinal Cord Stimulator Implant Study



Status:Completed
Conditions:Back Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - Any
Updated:7/20/2018
Start Date:November 2008
End Date:December 2014

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Pain Coping Skills Training for Spinal Cord Stimulator Implant Candidates

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.

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.

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
We found this trial at
1
site
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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