An interventional study of Coping Skills Training and Education in Back Pain, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-18.
Sponsored by Duke University · Not applicable, Interventional, and Treatment
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.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 101 is above the median of 60 across 1,941 interventional studies indexed under Back Pain.
Browse Back Pain studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Coping Skills Training in pain management
Behavioral: Coping Skills Training
Chronic Pain Education
Behavioral: Education
Patients receive no study intervention, continue with usual medical care.
Patients meet individually with therapist for 6 sessions to learn coping skills for stress management, behavioral activation, and communication.
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.
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
Time frame: 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 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.
Time frame: Pre-intervention, post intervention, 6 month, and 12 month follow-ups
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Duke University