Spinal Cord Stimulator Implant Study

Back Pain Clinical Trial

— SCS  

Official title:

Pain Coping Skills Training for Spinal Cord Stimulator Implant Candidates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00887419
• Other study ID #: Pro00000226
• Secondary ID: NIH R01-NS-05375
• Status: Completed
• Phase: N/A
• Start date: November 2008
• Est. completion date: December 2014

Study information

• Verified date: July 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain

Intervention

Behavioral:
• Coping Skills Training
Patients meet individually with therapist for 6 sessions to learn coping skills for stress management, behavioral activation, and communication.
• 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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Pre-intervention, post intervention, 6 month, and 12 month follow-ups