PainNCT02752386
Biofeedback Training to Control Pain Processing
A study testing Biofeedback Training in people with Pain, run by University of Tulsa at 1 site in United States.
Trial summary
The purpose of this study is to test whether a novel form of biofeedback training can help individuals regulate their pain more effectively. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Biofeedback Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 31 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy pain free individuals over the age of 18.
Who cannot join
- under 18 years of age (given the nature of the study)
- history of serious cardiovascular, neuroendocrine, or neurological disorders
- hypertension (due to a relationship between blood pressure and pain);5 4) history of chronic pain
- current opioid, antidepressant, or anxiolytic medication use
- psychosis or apparent cognitive impairment
- body mass index>35 (due to difficulty eliciting an NFR in persons with high adiposity)
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- inability to understand and read English (questionnaires and consent form are in English)
- recent use of an over-the-counter pain medication (within the last 24 hours) or narcotic medication (within the last two weeks)
- history of panic attacks. No one will be excluded based on ethnic, racial, or gender characteristics.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to test whether a novel form of biofeedback training can help individuals regulate their pain more effectively.
Read the 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 procedure to try to enhance the ability of relaxation to engage pain inhibition. Specifically, a biofeedback system will be used to provide training in conditioned pain regulation. The biofeedback system will monitor the trainee's level of sympathetic arousal and use it to control the intensity of painful stimulations delivered to the trainee during biofeedback. So when the trainee successfully relaxes (and reduced arousal), the intensity is lowered and produces pain relief. Efficacy of the training will be tested in a randomized controlled trial in which healthy, pain-free trainees are assigned to receive 3 training sessions or 3 sessions of a control procedure (2 other procedures will serve as controls; 3 groups total). The aim will be to assess whether the training results in inhibition of experimental pain and the nociceptive flexion reflex (NFR, a physiological marker of spinal pain signaling) to determine whether brain-to-spinal cord inhibitory circuits are engaged.
- Conditions
- Pain
- Being tested
- Biofeedback Training
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofeedback TrainingBehavioural
Participants will received biofeedback training to reduce arousal and pain
| Study group | Role | What they receive |
|---|---|---|
| Biofeedback Training 1 | Experimental | Participants will receive brief training in relaxation and biofeedback to develop basic skills in relaxation/arousal reduction. Then they will receive instructions to relax and reduce arousal as they view graphical arousal feedback. Electric stimulations will be delivered throughout the biofeedback to provide pain relief when relaxation is achieved. Receives: Behavioral: Biofeedback Training |
| Biofeedback Training 2 | Active comparator | Participants will receive brief training in relaxation and biofeedback to develop basic skills in relaxation/arousal reduction. Then they will receive instructions to relax and reduce arousal as they view graphical arousal feedback. Electric stimulations will be delivered throughout the biofeedback to provide a painful context in which to practice relaxing. Receives: Behavioral: Biofeedback Training |
| Biofeedback Training 3 | Active comparator | Participants will receive brief training in relaxation and biofeedback to develop basic skills in relaxation/arousal reduction. Then they will receive instructions to relax and reduce arousal as they view graphical arousal feedback. Receives: Behavioral: Biofeedback Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in nociceptive flexion reflex threshold
physiological marker of pain processing
Measured: Assessed at the beginning and end of each of the 3 biofeedback training days
Change in temporal summation of pain
marker of pain facilitation (change in pain rating 0-100 that occurs in response to a mechanical stimulus series)
Measured: Assessed at the beginning and end of each of the 3 biofeedback training days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study startFeb 2016
- Primary completionJul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tulsa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamie Rhudy, University of Tulsa
- Investigators
- Jamie L Rhudy, PhD, Principal investigator, The University of Tulsa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02752386
- Sponsor's protocol ID
- TU1560
- Status last verified
- Sep 2019
- First submitted
- 19 Apr 2016
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biofeedback Training to Control Pain Processing
- ClinicalTrials.gov ID
- NCT02752386
- Acronym / sponsor ID
- TU1560
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University of TulsaUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 27 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test whether a novel form of biofeedback training can help individuals regulate their 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 procedure to try to enhance the ability of relaxation to engage pain inhibition. Specifically, a biofeedback system will be used to provide training in conditioned pain regulation. The biofeedback system will monitor the trainee's level of sympathetic arousal and use it to control the intensity of painful stimulations delivered to the trainee during biofeedback. So when the trainee successfully relaxes (and reduced arousal), the intensity is lowered and produces pain relief. Efficacy of the training will be tested in a randomized controlled trial in which healthy, pain-free trainees are assigned to receive 3 training sessions or 3 sessions of a control procedure (2 other procedures will serve as controls; 3 groups total). The aim will be to assess whether the training results in inhibition of experimental pain and the nociceptive flexion reflex (NFR, a physiological marker of spinal pain signaling) to determine whether brain-to-spinal cord inhibitory circuits are engaged.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Biofeedback Training 1 | Experimental | Behavioral: Biofeedback TrainingParticipants will receive brief training in relaxation and biofeedback to develop basic skills in relaxation/arousal reduction. Then they will receive instructions to relax and reduce arousal as they view graphical arousal feedback. Electric stimulations will be delivered throughout the biofeedback to provide pain relief when relaxation is achieved. |
| Biofeedback Training 2 | Active comparator | Behavioral: Biofeedback TrainingParticipants will receive brief training in relaxation and biofeedback to develop basic skills in relaxation/arousal reduction. Then they will receive instructions to relax and reduce arousal as they view graphical arousal feedback. Electric stimulations will be delivered throughout the biofeedback to provide a painful context in which to practice relaxing. |
| Biofeedback Training 3 | Active comparator | Behavioral: Biofeedback TrainingParticipants will receive brief training in relaxation and biofeedback to develop basic skills in relaxation/arousal reduction. Then they will receive instructions to relax and reduce arousal as they view graphical arousal feedback. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy pain free individuals over the age of 18.
Key exclusion criteria (9 listed)
- under 18 years of age (given the nature of the study)
- history of serious cardiovascular, neuroendocrine, or neurological disorders
- hypertension (due to a relationship between blood pressure and pain);5 4) history of chronic pain
- current opioid, antidepressant, or anxiolytic medication use
- psychosis or apparent cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biofeedback TrainingParticipants will received biofeedback training to reduce arousal and pain | Behavioural | Biofeedback Training 1, Biofeedback Training 2, Biofeedback Training 3 |
Primary outcome
Change in nociceptive flexion reflex threshold
Time frame: Assessed at the beginning and end of each of the 3 biofeedback training days
physiological marker of pain processing
Change in temporal summation of pain
Time frame: Assessed at the beginning and end of each of the 3 biofeedback training days
marker of pain facilitation (change in pain rating 0-100 that occurs in response to a mechanical stimulus series)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamie L Rhudy, PhD principal investigator
The University of Tulsa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback Training in people with Pain, run by University of Tulsa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in nociceptive flexion reflex threshold (time frame: Assessed at the beginning and end of each of the 3 biofeedback training days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019; AzTrials last refreshed its copy on 30 Oct 2026.