Musculoskeletal Pain
Conditions
Keywords
chronic pain
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).
Interventions
BEHAVIORALBiofeedback Training (BT-CPR)
Participants will receive biofeedback training (which will include electric stimulations) to reduce arousal and pain
BEHAVIORALBiofeedback Training
Participants will receive biofeedback training to reduce arousal and pain
Sponsors
University of Tulsa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in clinical pain | 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). |
| Changes in psychosocial outcomes | 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
| Measure | Time frame | Description |
|---|---|---|
| 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). | Subjective ratings of painful stimuli |
Countries
United States
Outcome results
None listed