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Completed

NCT Number: NCT02920853

Enhanced Biofeedback for Musculoskeletal Pain

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Tulsa

Tulsa, Oklahoma, 74104, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biofeedback Training (BT-CPR)

Behavioral

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

biofeedback training

Behavioral

Participants will receive biofeedback training to reduce arousal and pain

Primary outcomes

  1. 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).

  2. 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).

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Tulsa

Other

Registry information

Official study title

Testing the Efficacy of Enhanced Biofeedback on Chronic Musculoskeletal Pain

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 30, 2016
Registry last updated
Aug 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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