Spinal Cord Stimulator Implant Study (SCS)
Primary Purpose
Back Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Coping Skills Training
Education
Sponsored by
About this trial
This is an interventional treatment trial for Back Pain focused on measuring chronic back pain, spinal cord stimulator implant
Eligibility Criteria
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
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Coping Skills Training
Education
Usual Care
Arm Description
Coping Skills Training in pain management
Chronic Pain Education
Patients receive no study intervention, continue with usual medical care.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00887419
Brief Title
Spinal Cord Stimulator Implant Study
Acronym
SCS
Official Title
Pain Coping Skills Training for Spinal Cord Stimulator Implant Candidates
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain
Keywords
chronic back pain, spinal cord stimulator implant
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Coping Skills Training
Arm Type
Experimental
Arm Description
Coping Skills Training in pain management
Arm Title
Education
Arm Type
Active Comparator
Arm Description
Chronic Pain Education
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Patients receive no study intervention, continue with usual medical care.
Intervention Type
Behavioral
Intervention Name(s)
Coping Skills Training
Intervention Description
Patients meet individually with therapist for 6 sessions to learn coping skills for stress management, behavioral activation, and communication.
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvements in pain, psychological distress, and physical disability
Description
Improvements in pain, psychological distress, and physical disability Pre-intervention, post-intervention, 6 month, and 12 month follow-ups
Time Frame
Pre-intervention, post-intervention, 6 month, and 12 month follow-ups
Secondary Outcome Measure Information:
Title
Patients will learn a repertoire of coping skills which can be applied to other challenges in life.
Description
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.
Time Frame
Pre-intervention, post intervention, 6 month, and 12 month follow-ups
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Porter, Ph.D.
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
12. IPD Sharing Statement
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Spinal Cord Stimulator Implant Study
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