Enhanced Biofeedback for Musculoskeletal Pain

Musculoskeletal Pain Clinical Trial

Official title:

Testing the Efficacy of Enhanced Biofeedback on Chronic Musculoskeletal Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02920853
• Other study ID #: TU1645
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: August 2018

Study information

• Verified date: August 2018
• Source: University of Tulsa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Musculoskeletal Pain

Intervention

Behavioral:
• Biofeedback Training (BT-CPR)
Participants will receive biofeedback training (which will include electric stimulations) to reduce arousal and pain
• Biofeedback Training
Participants will receive biofeedback training to reduce arousal and pain

Locations

Country	Name	City	State
United States	University of Tulsa	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Tulsa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Changes in reactions to painful stimuli	Subjective ratings of 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).