Back Pain
Conditions
Keywords
chronic back pain, spinal cord stimulator implant
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.
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.
Interventions
BEHAVIORALCoping Skills Training
Patients meet individually with therapist for 6 sessions to learn coping skills for stress management, behavioral activation, and communication.
BEHAVIORALEducation
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.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvements in pain, psychological distress, and physical disability | Pre-intervention, post-intervention, 6 month, and 12 month follow-ups | Improvements in pain, psychological distress, and physical disability Pre-intervention, post-intervention, 6 month, and 12 month follow-ups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Countries
United States
Outcome results
None listed