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| ID | Type | Description | Link |
|---|---|---|---|
| NIH R01-NS-053759 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coping Skills Training | Experimental | Coping Skills Training in pain management |
|
| Education | Active Comparator | Chronic Pain Education |
|
| Usual Care | No Intervention | Patients receive no study intervention, continue with usual medical care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coping Skills Training | Behavioral | Patients meet individually with therapist for 6 sessions to learn coping skills for stress management, behavioral activation, and communication. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Porter, Ph.D. | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
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| ID | Term |
|---|---|
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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| Education | Behavioral | 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. |
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