Temporomandibular DisorderNCT06357702
K23- Physical Self Regulation vs Placebo
A study testing Physical Self Regulation Telehealth and Psycho-education Telehealth in people with Temporomandibular Disorder, run by Ian Boggero, PhD at 1 site in United States.
Trial summary
This study will use a between-person design. Participants will be treatment-seeking patients with chronic masticatory muscle pain. Participants who are eligible for the study and consent to participate will be randomly assigned to receive a brief behavioral intervention for chronic orofacial pain called Physical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Temporomandibular Disorder
- What is being tested?
- Physical Self Regulation Telehealth and Psycho-education Telehealth
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2024to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a primary or secondary chronic masticatory muscle pain diagnosis
- Provide signed and dated electronic informed consent form
- Willing to comply with all study procedures
- Male or female, aged 18 or over
- Be able to speak and write in English
- Be seeking treatment at UKOPC
- Have the ability to perform telehealth visits (i.e., internet access, phone, tablet, computer or other device with audio/visual capabilities)
Who cannot join
- Currently using anticonvulsant, steroid, antispasmodic, or opioid medication for chronic pain 2 days a week or more often
- Have current or recent (within the last 3 months) psychotic, suicidal, homicidal, or manic symptoms. Participants with a history of such symptoms must demonstrate psychiatric stability for at least 6 months and be under the care of a medical or mental health professional for symptom management prior to being eligible for the study (must have written note from physician authorizing them to participate)
- Patients who are currently on medication for diabetes or seizures (i.e., epilepsy) must have written clearance from their medical providers prior to participating in the study
- History of seizures within the last 12 months
- Pain duration less than 3 months
- Pregnant or planning to become pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kentucky
Lexington, Kentucky, 40506
Ian Boggero, Ph.D., 8595623291, ian.boggero@uky.edu
About this study
Official title: Initial Evidence for a Brief Psychological Telehealth Intervention for Patients With Chronic Masticatory Muscle Pain
This study will use a between-person design. Participants will be treatment-seeking patients with chronic masticatory muscle pain. Participants who are eligible for the study and consent to participate will be randomly assigned to receive a brief behavioral intervention for chronic orofacial pain called Physical Self-Regulation or a control intervention. Interventions will be administered via telehealth in both arms. Both interventions will consist of 2 50-minute sessions scheduled approximately two weeks apart. Participants will be contacted two weeks and three months after completing the interventions to provide additional follow-up data. Investigators hypothesize that both PSR-TH and the control intervention will demonstrate strong feasibility (i.e., recruitment of at least 1 participant per week, >75% retention, >95% interventionist fidelity, and adequate acceptability, credibility, and burden). Investigators also hypothesize that specific biopsychosocial variables will moderate PSR-TH-related changes in outcomes, and that PSR-TH-related changes in perceived control over pain, self-efficacy, coping, parafunctional habits, and relaxation will mediate treatment effects.
Read the detailed description
Chronic masticatory muscle pain disorders (MMPD) consist of several conditions (e.g., myofascial pain, local myalgia) characterized by pain in the muscles of the temporomandibular area lasting longer than three months. MMPD affects 5-12% of adults, is the most common cause of chronic non-odontogenic facial pain, and the second most common musculoskeletal pain condition after chronic low back pain. MMPD is associated with pain-related interference with daily activities, diminished quality of life (QoL) and costs of > $4 billion/year in the US, representing a serious public health issue. Chronic MMPD is most effectively managed with multidisciplinary treatment. One brief psychological intervention that has been particularly promising for improving orofacial pain outcomes and QoL in MMPD is physical self-regulation (PSR). Relative to standard dental care (SDC) alone, those who received SDC+PSR experienced reduced pain intensity up to 6.5 months later (Cohen's D = 0.67). These data suggest that PSR may be a promising intervention for improving pain outcomes in MMPD. Despite the promise of PSR, one of its major shortcomings is that treatment utilization is low, with less than 50% of eligible patients beginning PSR when offered in person. Offering PSR via telehealth may be a solution. Telehealth interventions improve access to care and are preferred by patients over in-person interventions. Preliminary data of treatment utilization for PSR-TH are promising, with over 80% of eligible patients beginning the intervention when offered via telehealth. However, it is not known if PSR-TH is efficacious above and beyond nonspecific treatment effects (e.g., people having more contact with a therapist, people inadvertently modifying their behavior to please their therapist, natural regression to the mean of pain symptoms, etc.). The efficacy of PSR-TH to treat MMPD needs to be formally tested; however, additional data regarding feasibility and moderating/mediating factors of PSRTH are needed to support such a trial. First, PSR-TH and a control intervention need to be formally piloted in patients with MMPD to 1) determine how willing patients are to participate in research (i.e., recruitment), 2) determine the completion rates for both interventions (i.e., retention), 3) quantify how well interventionists are able to deliver the interventions in a standardized way (i.e., fidelity), and 4) establish patients' perceived acceptability, credibility, and burden of both interventions. Second, a body of work has examined biopsychosocial moderators and mediators of responses to psychological interventions (e.g., cognitive behavioral therapy, [CBT]) in MMPD, but never of PSR-TH specifically. Identifying relevant moderators and mediators in this project will allow for more thorough assessment of those specific relationships in a future Phase II trial, advancing understanding of how PSR-TH works, and for whom. To accomplish these aims, treatment-seeking patients with chronic MMPD will be randomly assigned to two 50-min telehealth sessions of PSR or a control intervention (N=52/group) and will provide biopsychosocial moderator, mediator, and outcome data at baseline, after each intervention sessions, two weeks following the intervention, and three months following the intervention. The investigators hypothesize that both PSR-TH and the control intervention will demonstrate strong feasibility (i.e., recruitment of at least 1 participant per week, >75% retention, >95% interventionist fidelity, and adequate acceptability, credibility, and burden). The investigators also hypothesize that specific biopsychosocial variables will moderate PSR-TH-related changes in outcomes, and that PSR-TH-related changes in perceived control over pain, self-efficacy, coping, parafunctional habits, and relaxation will mediate treatment effects.
- Conditions
- Temporomandibular Disorder
- Being tested
- Physical Self Regulation Telehealth, Psycho-education Telehealth
- Keywords
- myalgia, orofacial, telehealth
- Medical subject headings
- Temporomandibular Joint Disorders, Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Self Regulation TelehealthBehavioural
Also called PSR-TH
2 sessions of an intervention delivered via telehealth. Session 1 includes awareness and strategies for monitoring habits and 4 exercises to practice 5 times per day. Session 2 will be 2 weeks later and is a review of session 1 and an introduction to diaphragmatic breathing. Breathing is practiced for 15 minutes twice per day.
Psycho-education TelehealthBehavioural
Also called Control
2 sessions of an intervention delivered via telehealth. Session 1 includes discussing trigeminal nerve function, jaw and muscle anatomy, posture, pain referral patterns, and stress biology. Participants rate pain and jaw fatigue 5 times per day. Session 2 will be 2 weeks later and consists of checking on the homework and information from session 1,followed by a discussion of autonomic nervous system activity, and a discussion of sleep quality and sleep hygiene. Participants will be instructed to rate their stress levels, pain, and mood several times per day, similar to the times when participants in the PSR-TH condition would be practicing diaphragmatic breathing
| Study group | Role | What they receive |
|---|---|---|
| Physical Self Regulation | Experimental | 2 experimental telehealth sessions approximately 2 weeks apart Receives: Behavioral: Physical Self Regulation Telehealth |
| Psycho-education | Active comparator | 2 control telehealth sessions approximately 2 weeks apart Receives: Behavioral: Psycho-education Telehealth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity
Pain intensity will be measured with the Graded Chronic Pain Scale Pain Intensity Subscale. Participants rate their worst pain, least pain, average pain, in the last 24 hours and pain right now using an 11 point Likert scale ranging from 0 to 10 with higher scores equating to greater pain. Scores are averaged for the total pain intensity score.
Measured: Baseline (week 0), post intervention (week 5) and 3-month follow-up (week 15)
Change in pain interference
Pain interference will be measured with the The Graded Chronic Pain Scale Pain Interference Subscale. Participants rate how much the pain has interfered with 7 daily activities on an 11 point Likert scale ranging from 0 to 10 with higher scores equating to greater interference. Pain interference is scored as the mean of the 7 items.
Measured: Baseline (week 0), post intervention (week 5) and 3-month follow-up (week 15)
Change in quality of life
Quality of life will be measured with the Satisfaction with Life Scale. Likert scale with 7 items scores range from 7 to 35 with higher scores equating to better quality of life.
Measured: Baseline (week 0), post intervention (week 5) and 3-month follow-up (week 15)
Recruitment rate
Number of patients who are consented into the study per month
Measured: Baseline (week 0)
Retention rate
Number of consented patients who also complete the three-month follow-up assessment
Measured: Follow up Visit at Month 3 (week 15)
Interventionist Fidelity Session 1
Each intervention session will have a checklist of items that need to be covered by the interventionists. All study sessions will be audio-recorded. A subset of all audio recordings will be checked for interventionist fidelity, defined by the following percentage:
Total items covered by interventionist/ Total possible items to be covered in that session
Measured: Study Visit 1 (week 1)
Interventionist Fidelity Session 2
Each intervention session will have a checklist of items that need to be covered by the interventionists. All study sessions will be audio-recorded. A subset of all audio recordings will be checked for interventionist fidelity, defined by the following percentage:
Total items covered by interventionist/ Total possible items to be covered in that session
Measured: Study Visit 2 (week 3)
Treatment Acceptability
Treatment Acceptability and Adherence Scale. The scale will measure what participants overall evaluation of if treatment was fair, reasonable, and appropriate. 6 item Likert scale with scores on each item ranging from 1 to 9 with higher scores equating to greater acceptability. Acceptability is scored as the mean of the 6 items.
Measured: Study Visits 1 and 2 (up to 2 weeks)
Treatment Credibility
Treatment Credibility/Expectancy Scale will measure how feasible is it the intervention will work and work for the participant.
6 item Likert scale with scores on each item ranging from 1 to 9 with higher scores equating to greater credibility. Acceptability is scored as the mean of the 6 items.
Measured: Study Visits 1 and 2 (up to 2 weeks)
Research Burden
Research burden will be measured by administering 8 selected items from the Perceived Research Burden Assessment. Participants rate how burdensome the study was on an 8 item assessment on a 5 point Likert scale ranging from strongly disagree to strongly agree with higher scores equating to greater burden. Burden is scored as mean of the 8 items.
Measured: Follow up Visit at Month 3 (week 15)
Secondary outcomes (1)
Treatment Satisfaction
Treatment Satisfaction Questionnaire 8 items on a 4 point Likert scale. Higher scores equate to greater satisfaction. Satisfaction is scored as mean of the 8 items.
Measured: 2-week follow-up (week 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start4 Apr 2024
- Primary completion1 Jun 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisorderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ian Boggero, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor-investigator, Ian Boggero, PhD, University of Kentucky
- Investigators
- Ian Boggero, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06357702
- Sponsor's protocol ID
- 81313
- Other IDs
- K23DE031807
- Status last verified
- Jun 2026
- First submitted
- 4 Apr 2024
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Evidence for a Brief Psychological Telehealth Intervention for Patients With Chronic Masticatory Muscle Pain
- ClinicalTrials.gov ID
- NCT06357702
- Acronym / sponsor ID
- 81313
- Conditions
- Temporomandibular Disorder
- Keywords
- myalgia, orofacial, telehealth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Ian Boggero, PhDUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 10 Apr 2024 (actual)
- 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.
This study will use a between-person design. Participants will be treatment-seeking patients with chronic masticatory muscle pain. Participants who are eligible for the study and consent to participate will be randomly assigned to receive a brief behavioral intervention for chronic orofacial pain called Physical Self-Regulation or a control intervention. Interventions will be administered via telehealth in both arms. Both interventions will consist of 2 50-minute sessions scheduled approximately two weeks apart. Participants will be contacted two weeks and three months after completing the interventions to provide additional follow-up data. Investigators hypothesize that both PSR-TH and the control intervention will demonstrate strong feasibility (i.e., recruitment of at least 1 participant per week, >75% retention, >95% interventionist fidelity, and adequate acceptability, credibility, and burden). Investigators also hypothesize that specific biopsychosocial variables will moderate PSR-TH-related changes in outcomes, and that PSR-TH-related changes in perceived control over pain, self-efficacy, coping, parafunctional habits, and relaxation will mediate treatment effects.
Detailed description
Chronic masticatory muscle pain disorders (MMPD) consist of several conditions (e.g., myofascial pain, local myalgia) characterized by pain in the muscles of the temporomandibular area lasting longer than three months. MMPD affects 5-12% of adults, is the most common cause of chronic non-odontogenic facial pain, and the second most common musculoskeletal pain condition after chronic low back pain. MMPD is associated with pain-related interference with daily activities, diminished quality of life (QoL) and costs of > $4 billion/year in the US, representing a serious public health issue. Chronic MMPD is most effectively managed with multidisciplinary treatment. One brief psychological intervention that has been particularly promising for improving orofacial pain outcomes and QoL in MMPD is physical self-regulation (PSR). Relative to standard dental care (SDC) alone, those who received SDC+PSR experienced reduced pain intensity up to 6.5 months later (Cohen's D = 0.67). These data suggest that PSR may be a promising intervention for improving pain outcomes in MMPD. Despite the promise of PSR, one of its major shortcomings is that treatment utilization is low, with less than 50% of eligible patients beginning PSR when offered in person. Offering PSR via telehealth may be a solution. Telehealth interventions improve access to care and are preferred by patients over in-person interventions. Preliminary data of treatment utilization for PSR-TH are promising, with over 80% of eligible patients beginning the intervention when offered via telehealth. However, it is not known if PSR-TH is efficacious above and beyond nonspecific treatment effects (e.g., people having more contact with a therapist, people inadvertently modifying their behavior to please their therapist, natural regression to the mean of pain symptoms, etc.). The efficacy of PSR-TH to treat MMPD needs to be formally tested; however, additional data regarding feasibility and moderating/mediating factors of PSRTH are needed to support such a trial. First, PSR-TH and a control intervention need to be formally piloted in patients with MMPD to 1) determine how willing patients are to participate in research (i.e., recruitment), 2) determine the completion rates for both interventions (i.e., retention), 3) quantify how well interventionists are able to deliver the interventions in a standardized way (i.e., fidelity), and 4) establish patients' perceived acceptability, credibility, and burden of both interventions. Second, a body of work has examined biopsychosocial moderators and mediators of responses to psychological interventions (e.g., cognitive behavioral therapy, [CBT]) in MMPD, but never of PSR-TH specifically. Identifying relevant moderators and mediators in this project will allow for more thorough assessment of those specific relationships in a future Phase II trial, advancing understanding of how PSR-TH works, and for whom. To accomplish these aims, treatment-seeking patients with chronic MMPD will be randomly assigned to two 50-min telehealth sessions of PSR or a control intervention (N=52/group) and will provide biopsychosocial moderator, mediator, and outcome data at baseline, after each intervention sessions, two weeks following the intervention, and three months following the intervention. The investigators hypothesize that both PSR-TH and the control intervention will demonstrate strong feasibility (i.e., recruitment of at least 1 participant per week, >75% retention, >95% interventionist fidelity, and adequate acceptability, credibility, and burden). The investigators also hypothesize that specific biopsychosocial variables will moderate PSR-TH-related changes in outcomes, and that PSR-TH-related changes in perceived control over pain, self-efficacy, coping, parafunctional habits, and relaxation will mediate treatment effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Self Regulation | Experimental | Behavioral: Physical Self Regulation Telehealth2 experimental telehealth sessions approximately 2 weeks apart |
| Psycho-education | Active comparator | Behavioral: Psycho-education Telehealth2 control telehealth sessions approximately 2 weeks apart |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Have a primary or secondary chronic masticatory muscle pain diagnosis
- Provide signed and dated electronic informed consent form
- Willing to comply with all study procedures
- Male or female, aged 18 or over
- Be able to speak and write in English
Key exclusion criteria (6 listed)
- Currently using anticonvulsant, steroid, antispasmodic, or opioid medication for chronic pain 2 days a week or more often
- Have current or recent (within the last 3 months) psychotic, suicidal, homicidal, or manic symptoms. Participants with a history of such symptoms must demonstrate psychiatric stability for at least 6 months and be under the care of a medical or mental health professional for symptom management prior to being eligible for the study (must have written note from physician authorizing them to participate)
- Patients who are currently on medication for diabetes or seizures (i.e., epilepsy) must have written clearance from their medical providers prior to participating in the study
- History of seizures within the last 12 months
- Pain duration less than 3 months
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 |
|---|---|---|
| Physical Self Regulation TelehealthAlso: PSR-TH2 sessions of an intervention delivered via telehealth. Session 1 includes awareness and strategies for monitoring habits and 4 exercises to practice 5 times per day. Session 2 will be 2 weeks later and is a review of session 1 and an introduction to diaphragmatic breathing. Breathing is practiced for 15 minutes twice per day. | Behavioural | Physical Self Regulation |
| Psycho-education TelehealthAlso: Control2 sessions of an intervention delivered via telehealth. Session 1 includes discussing trigeminal nerve function, jaw and muscle anatomy, posture, pain referral patterns, and stress biology. Participants rate pain and jaw fatigue 5 times per day. Session 2 will be 2 weeks later and consists of checking on the homework and information from session 1,followed by a discussion of autonomic nervous system activity, and a discussion of sleep quality and sleep hygiene. Participants will be instructed to rate their stress levels, pain, and mood several times per day, similar to the times when participants in the PSR-TH condition would be practicing diaphragmatic breathing | Behavioural | Psycho-education |
Primary outcome
Change in pain intensity
Time frame: Baseline (week 0), post intervention (week 5) and 3-month follow-up (week 15)
Pain intensity will be measured with the Graded Chronic Pain Scale Pain Intensity Subscale. Participants rate their worst pain, least pain, average pain, in the last 24 hours and pain right now using an 11 point Likert scale ranging from 0 to 10 with higher scores equating to greater pain. Scores are averaged for the total pain intensity score.
Change in pain interference
Time frame: Baseline (week 0), post intervention (week 5) and 3-month follow-up (week 15)
Pain interference will be measured with the The Graded Chronic Pain Scale Pain Interference Subscale. Participants rate how much the pain has interfered with 7 daily activities on an 11 point Likert scale ranging from 0 to 10 with higher scores equating to greater interference. Pain interference is scored as the mean of the 7 items.
Change in quality of life
Time frame: Baseline (week 0), post intervention (week 5) and 3-month follow-up (week 15)
Quality of life will be measured with the Satisfaction with Life Scale. Likert scale with 7 items scores range from 7 to 35 with higher scores equating to better quality of life.
Recruitment rate
Time frame: Baseline (week 0)
Number of patients who are consented into the study per month
Retention rate
Time frame: Follow up Visit at Month 3 (week 15)
Number of consented patients who also complete the three-month follow-up assessment
Interventionist Fidelity Session 1
Time frame: Study Visit 1 (week 1)
Each intervention session will have a checklist of items that need to be covered by the interventionists. All study sessions will be audio-recorded. A subset of all audio recordings will be checked for interventionist fidelity, defined by the following percentage: Total items covered by interventionist/ Total possible items to be covered in that session
Interventionist Fidelity Session 2
Time frame: Study Visit 2 (week 3)
Each intervention session will have a checklist of items that need to be covered by the interventionists. All study sessions will be audio-recorded. A subset of all audio recordings will be checked for interventionist fidelity, defined by the following percentage: Total items covered by interventionist/ Total possible items to be covered in that session
Treatment Acceptability
Time frame: Study Visits 1 and 2 (up to 2 weeks)
Treatment Acceptability and Adherence Scale. The scale will measure what participants overall evaluation of if treatment was fair, reasonable, and appropriate. 6 item Likert scale with scores on each item ranging from 1 to 9 with higher scores equating to greater acceptability. Acceptability is scored as the mean of the 6 items.
Treatment Credibility
Time frame: Study Visits 1 and 2 (up to 2 weeks)
Treatment Credibility/Expectancy Scale will measure how feasible is it the intervention will work and work for the participant. 6 item Likert scale with scores on each item ranging from 1 to 9 with higher scores equating to greater credibility. Acceptability is scored as the mean of the 6 items.
Research Burden
Time frame: Follow up Visit at Month 3 (week 15)
Research burden will be measured by administering 8 selected items from the Perceived Research Burden Assessment. Participants rate how burdensome the study was on an 8 item assessment on a 5 point Likert scale ranging from strongly disagree to strongly agree with higher scores equating to greater burden. Burden is scored as mean of the 8 items.
1 secondary outcome
Treatment Satisfaction
Time frame: 2-week follow-up (week 5)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- 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.
Ian Boggero, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Self Regulation Telehealth and Psycho-education Telehealth in people with Temporomandibular Disorder, run by Ian Boggero, PhD 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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 17 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Courtney Brown (8593230246, cbrown@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity (time frame: Baseline (week 0), post intervention (week 5) and 3-month follow-up (week 15)). The study lists 10 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 17 Jun 2026.