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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
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain focused on measuring chronic back pain, spinal cord stimulator implant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
April 23, 2009
Last Updated
July 17, 2018
Sponsor
Duke University
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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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