Enhanced Biofeedback for Musculoskeletal Pain

University of Tulsa

Status: Completed

Conditions: Musculoskeletal Pain

Treatments: Behavioral: Biofeedback Training; Behavioral: Biofeedback Training (BT-CPR)

Study type: Interventional

Funder types: Other

Identifiers

NCT02920853

TU1645

Details and patient eligibility

About

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.

Full 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).

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

BT-CPR

Experimental group

Description:

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.

Treatment:

Behavioral: Biofeedback Training (BT-CPR)

Biofeedback-Only

Active Comparator group

Description:

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.

Treatment:

Behavioral: Biofeedback Training