Enhanced Biofeedback for Musculoskeletal Pain

NCT ID: NCT02920853

Last Updated: 2018-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2018-08-31

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).

Conditions

Musculoskeletal Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Biofeedback Training (BT-CPR)

Intervention Type: BEHAVIORAL

Participants will receive biofeedback training (which will include electric stimulations) to reduce arousal and pain

Biofeedback-Only

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.

Group Type: ACTIVE_COMPARATOR

Biofeedback Training

Intervention Type: BEHAVIORAL

Participants will receive biofeedback training to reduce arousal and pain

Interventions

Biofeedback Training (BT-CPR)

Participants will receive biofeedback training (which will include electric stimulations) to reduce arousal and pain

Intervention Type: BEHAVIORAL

Biofeedback Training

Participants will receive biofeedback training to reduce arousal and pain

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Tulsa

OTHER

Sponsor Role: lead

Responsible Party

Jamie Rhudy

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jamie L Rhudy, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Tulsa

Locations

University of Tulsa

Tulsa, Oklahoma, United States

Countries

United States

Other Identifiers

TU1645

Identifier Type: -

Identifier Source: org_study_id