Spinal Cord Stimulator Implant Study
SCS
Pain Coping Skills Training for Spinal Cord Stimulator Implant Candidates
2 other identifiers
interventional
101
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 23, 2009
CompletedFirst Posted
Study publicly available on registry
April 24, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJuly 18, 2018
July 1, 2018
5.1 years
April 23, 2009
July 17, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Patients will learn a repertoire of coping skills which can be applied to other challenges in life.
Pre-intervention, post intervention, 6 month, and 12 month follow-ups
Study Arms (3)
Coping Skills Training
EXPERIMENTALCoping Skills Training in pain management
Education
ACTIVE COMPARATORChronic Pain Education
Usual Care
NO INTERVENTIONPatients receive no study intervention, continue with usual medical care.
Interventions
Patients meet individually with therapist for 6 sessions to learn coping skills for stress management, behavioral activation, and communication.
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
You may qualify if:
- 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
You may not qualify if:
- pending litigation
- not approved for implant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
Study Sites (1)
Duke University Medical Center
Durham, North Carolina, 27705, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laura Porter, Ph.D.
Duke University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2009
First Posted
April 24, 2009
Study Start
November 1, 2008
Primary Completion
December 1, 2013
Study Completion
December 1, 2014
Last Updated
July 18, 2018
Record last verified: 2018-07