Spinal Cord Stimulator Implant Study (SCS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00887419
Recruitment Status : Completed
First Posted : April 24, 2009
Last Update Posted : June 27, 2017
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Back Pain Behavioral: Coping Skills Training Behavioral: Education Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pain Coping Skills Training for Spinal Cord Stimulator Implant Candidates
Study Start Date : November 2008
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Improvements in pain, psychological distress, and physical disability [ Time Frame: Pre-intervention, post-intervention, 6 month, and 12 month follow-ups ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00887419

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

Responsible Party: Duke University Identifier: NCT00887419     History of Changes
Other Study ID Numbers: Pro00000226
NIH R01-NS-053759
First Posted: April 24, 2009    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017

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

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