Enhanced Biofeedback for Musculoskeletal Pain

Not Applicable

Completed

• Conditions: Musculoskeletal Pain
• Interventions: Behavioral: Biofeedback Training; Behavioral: Biofeedback Training (BT-CPR)

• Registration Number: NCT02920853
• Lead Sponsor: University of Tulsa

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 Description

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).

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-26
• Study First Submitted QC: 2016-09-28
• Study First Posted: 2016-09-30
• Status Verified: 2018-08
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Last Update Submitted: 2018-08-17
• Last Update Posted: 2018-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Adults (18 years or older) with a verified diagnosis of chronic musculoskeletal pain and currently experiencing pain

Exclusion Criteria

• under 18 years of age (given the nature of the treatment study)
• if female, currently pregnant
• persistent feelings of numbness in hands and feet
• difficulty being able to feel or sense things
• lack of access to a computer or smartphone (to complete electronic pain diaries)
• injuries that prevent sensor application
• use of narcotic pain medications with 48 hours of treatment sessions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biofeedback-Only	Biofeedback Training	Participants will receive training in relaxation and biofeedback to develop skills in relaxation/arousal reduction, and pain reduction. Then they will practice relaxing and reducing their arousal as they view graphical arousal feedback.
BT-CPR	Biofeedback Training (BT-CPR)	Participants will receive training in relaxation and biofeedback to develop skills in relaxation/arousal reduction, and pain reduction. Then they will practice relaxing and reducing their arousal as they view graphical arousal feedback. Electric stimulations will be delivered throughout the biofeedback training to provide pain relief when relaxation is achieved.

Primary Outcome Measures

Name	Time	Method
Changes in clinical pain	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	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).

Secondary Outcome Measures

Name	Time	Method
Changes in reactions to painful stimuli	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

Trial Locations

Locations (1)

University of Tulsa; 🇺🇸 Tulsa, Oklahoma, United States