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Enhanced Biofeedback for Musculoskeletal Pain

Primary Purpose

Musculoskeletal Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biofeedback Training (BT-CPR)
Biofeedback Training
Sponsored by
University of Tulsa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Musculoskeletal Pain focused on measuring chronic pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Tulsa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BT-CPR

Biofeedback-Only

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

Changes in reactions to painful stimuli
Subjective ratings of painful stimuli

Full Information

First Posted
September 26, 2016
Last Updated
August 17, 2018
Sponsor
University of Tulsa
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1. Study Identification

Unique Protocol Identification Number
NCT02920853
Brief Title
Enhanced Biofeedback for Musculoskeletal Pain
Official Title
Testing the Efficacy of Enhanced Biofeedback on Chronic Musculoskeletal Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Tulsa

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Pain
Keywords
chronic pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BT-CPR
Arm Type
Experimental
Arm Description
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.
Arm Title
Biofeedback-Only
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Biofeedback Training (BT-CPR)
Intervention Description
Participants will receive biofeedback training (which will include electric stimulations) to reduce arousal and pain
Intervention Type
Behavioral
Intervention Name(s)
Biofeedback Training
Intervention Description
Participants will receive biofeedback training to reduce arousal and pain
Primary Outcome Measure Information:
Title
Changes in clinical pain
Description
Self-report ratings of pain intensity, rated using 0-10 Likert-type scales, (i.e., 0 = no pain; 10 = most intense 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)
Title
Changes in psychosocial outcomes
Description
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).
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)
Secondary Outcome Measure Information:
Title
Changes in reactions to painful stimuli
Description
Subjective ratings of 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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamie L Rhudy, PhD
Organizational Affiliation
The University of Tulsa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Tulsa
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Enhanced Biofeedback for Musculoskeletal Pain

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