Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
101 participants
INTERVENTIONAL
2008-11-30
2014-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Coping Skills Training
Coping Skills Training in pain management
Coping Skills Training
Patients meet individually with therapist for 6 sessions to learn coping skills for stress management, behavioral activation, and communication.
Education
Chronic Pain Education
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.
Usual Care
Patients receive no study intervention, continue with usual medical care.
No interventions assigned to this group
Interventions
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Coping Skills Training
Patients meet individually with therapist for 6 sessions to learn coping skills for stress management, behavioral activation, and communication.
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.
Eligibility Criteria
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Inclusion Criteria
* approved by physician and psychologist for implant
* ability to read and write English
* at least 18 years old
Exclusion Criteria
* not approved for implant
18 Years
ALL
No
Sponsors
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Duke University
OTHER
Responsible Party
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Principal Investigators
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Laura Porter, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke University Medical Center
Durham, North Carolina, United States
Countries
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Other Identifiers
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NIH R01-NS-053759
Identifier Type: -
Identifier Source: secondary_id
Pro00000226
Identifier Type: -
Identifier Source: org_study_id
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