Spinal Cord Stimulator Implant Study (SCS)

Duke University

Status: Completed

Conditions: Back Pain

Treatments: Behavioral: Education; Behavioral: Coping Skills Training

Study type: Interventional

Funder types: Other

Identifiers

NCT00887419

NIH R01-NS-053759

Pro00000226

Details and patient eligibility

About

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.

Full 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.

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 3 patient groups

Coping Skills Training

Experimental group

Description:

Coping Skills Training in pain management

Treatment:

Behavioral: Coping Skills Training

Education

Active Comparator group

Description:

Chronic Pain Education

Treatment:

Behavioral: Education

Usual Care

No Intervention group

Description:

Patients receive no study intervention, continue with usual medical care.