Clinical Trial: Enhanced Biofeedback for Musculoskeletal Pain

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Testing the Efficacy of Enhanced Biofeedback on Chronic Musculoskeletal Pain

Brief Summary: The purpose of this study is to assess whether a novel, enhanced form of biofeedback can help individuals regulate their chronic musculoskeletal pain more effectively.

Detailed Summary: Relaxation is a low-cost treatment for managing pain with little or no side effects. The proposed study will use a novel biofeedback treatment to try and enhance the capacity of relaxation to engage pain inhibitory circuits. Specifically, a biofeedback system (Biofeedback Training for Conditioned Pain Regulation, BT-CPR) will be used to monitor the participant's level of sympathetic arousal and will use this to control the intensity of painful stimulations delivered to the participant during biofeedback training. Thus, when the participant successfully relaxes (and reduces their arousal), the intensity is lowered and produces pain relief. Efficacy of the treatment will be tested in a small, randomized controlled trial in which individuals with a verified diagnosis of chronic musculoskeletal pain will receive 10 treatment sessions, or 10 sessions of a control condition (traditional biofeedback, to control for the effects of relaxation on pain). The aim will be to assess whether the treatment results in improvements in clinical pain outcomes (e.g., pain intensity, quality of life, pain interference) and psychosocial variables (e.g., coping, self-efficacy, mood).
Sponsor: University of Tulsa

Current Primary Outcome:

  • Changes in clinical pain [ Time Frame: Assessed daily via electronic diaries starting 1 week prior to session 1 and ending 1 week after session 10 (up to 11 weeks) ]
    Self-report ratings of pain intensity, rated using 0-10 Likert-type scales, (i.e., 0 = no pain; 10 = most intense pain).
  • Changes in psychosocial outcomes [ Time Frame: Assessed daily via electronic diaries starting 1 week prior to session 1 and ending 1 week after session 10 (up to 11 weeks) ]
    Self-report ratings of pain interference, mood, sleep quality, and coping. These items are rated using 0-10 Likert-type scales, (e.g., 0 = no change; 10 = extreme change) with higher values indicating an increase in the variable assessed on a particular item (e.g., interference with daily activities).


Original Primary Outcome: Same as current

Current Secondary Outcome: Changes in reactions to painful stimuli [ Time Frame: Assessed immediately before the first treatment session (Time 1) and immediately after (Time 2) the last treatment session (approximately 10 weeks from Time 1). ]

Subjective ratings of painful stimuli


Original Secondary Outcome: Same as current

Information By: University of Tulsa

Dates:
Date Received: September 26, 2016
Date Started: September 2016
Date Completion: August 2020
Last Updated: September 28, 2016
Last Verified: September 2016