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Completed

NCT Number: NCT00887419

Spinal Cord Stimulator Implant Study

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.

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Key information

Conditions

Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coping Skills Training

Behavioral

Patients meet individually with therapist for 6 sessions to learn coping skills for stress management, behavioral activation, and communication.

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.

Primary outcomes

  1. Improvements in pain, psychological distress, and physical disability

    Time frame: 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 outcomes

  1. Patients will learn a repertoire of coping skills which can be applied to other challenges in life.

    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 Pre-intervention, post intervention, 6 month, and 12 month follow-upslife.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Pain Coping Skills Training for Spinal Cord Stimulator Implant Candidates

Acronym: SCS

Important dates

Study start
2008
Primary completion
2013
Study completion
2014
First posted
Apr 24, 2009
Registry last updated
Jul 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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