Clinical trial NCT02920853: Enhanced Biofeedback for Musculoskeletal Pain
Official title: Testing the Efficacy of Enhanced Biofeedback on Chronic Musculoskeletal Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Pain
Keywords: chronic pain
Lead sponsor: University of Tulsa
Sponsor class: OTHER
First posted: 2016-09-30
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Changes in clinical pain
timeFrame: Assessed daily via electronic diaries starting 1 week prior to session 1 and ending 1 week after session 10 (up to 11 weeks)
measure: Changes in psychosocial outcomes
timeFrame: 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:
measure: Changes in reactions to painful stimuli
timeFrame: Assessed immediately before the first treatment session (Time 1) and immediately after (Time 2) the last treatment session (approximately 10 weeks from Time 1).
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: University of Tulsa
state: Oklahoma
Study officials:
affiliation: The University of Tulsa
name: Jamie L Rhudy, PhD
role: PRINCIPAL_INVESTIGATOR
References: