Spinal Cord Stimulator Implant Study (SCS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00887419
First received: April 23, 2009
Last updated: July 8, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Back Pain
Behavioral: Coping Skills Training
Behavioral: Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pain Coping Skills Training for Spinal Cord Stimulator Implant Candidates

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Improvements in pain, psychological distress, and physical disability [ Time Frame: Pre-intervention, post-intervention, 6 month, and 12 month follow-ups ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patients will learn a repertoire of coping skills which can be applied to other challenges in life. [ Time Frame: Pre-intervention, post intervention, 6 month, and 12 month follow-ups ] [ Designated as safety issue: No ]

Estimated Enrollment: 128
Study Start Date: November 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Coping Skills Training
Coping Skills Training in pain management
Behavioral: Coping Skills Training
Patients meet individually with therapist for 6 sessions to learn coping skills for stress management, behavioral activation, and communication.
Active Comparator: Education
Chronic Pain Education
Behavioral: 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.
No Intervention: Usual Care
Patients receive no study intervention, continue with usual medical care.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00887419

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Laura Porter, Ph.D. Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00887419     History of Changes
Other Study ID Numbers: Pro00000226, NIH R01-NS-053759
Study First Received: April 23, 2009
Last Updated: July 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
chronic back pain
spinal cord stimulator implant

Additional relevant MeSH terms:
Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014