Enhanced Biofeedback for Musculoskeletal Pain

NCT02920853 | Completed

• 1 other identifier: TU1645
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Musculoskeletal Pain

Keywords

chronic pain

Outcome Measures

Primary Outcomes (2)

• Changes in clinical pain

  Self-report ratings of pain intensity, rated using 0-10 Likert-type scales, (i.e., 0 = no pain; 10 = most intense pain).

  Assessed daily via electronic diaries starting 1 week prior to session 1 and ending 1 week after session 10 (up to 11 weeks)

• Changes in psychosocial outcomes

  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).

  Assessed daily via electronic diaries starting 1 week prior to session 1 and ending 1 week after session 10 (up to 11 weeks)

Secondary Outcomes (1)

• 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).

Study Arms (2)

BT-CPR

EXPERIMENTAL

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.

Behavioral: Biofeedback Training (BT-CPR)

Biofeedback-Only

ACTIVE COMPARATOR

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.

Behavioral: Biofeedback Training

Interventions

Biofeedback Training (BT-CPR) BEHAVIORAL

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

BT-CPR

Biofeedback Training BEHAVIORAL

Participants will receive biofeedback training to reduce arousal and pain

Biofeedback-Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Tulsa: lead

Study Sites (1)

University of Tulsa

Tulsa, Oklahoma, 74104, United States

Location

MeSH Terms

Conditions

Musculoskeletal Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jamie L Rhudy, PhD

  The University of Tulsa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 26, 2016
• First Posted: September 30, 2016
• Study Start: September 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 21, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)