Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06357702
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-04-04
Brief Title:
K23- Physical Self Regulation vs Placebo
Sponsor:
Ian Boggero PhD
Organization:
University of Kentucky
Study Overview
Official Title:
Initial Evidence for a Brief Psychological Telehealth Intervention for Patients With Chronic Masticatory Muscle Pain
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 ie 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 eg 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 billionyear 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 SDCPSR experienced reduced pain intensity up to 65 months later Cohens D 067 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 eg 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 moderatingmediating 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 ie recruitment 2 determine the completion rates for both interventions ie retention 3 quantify how well interventionists are able to deliver the interventions in a standardized way ie 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 eg 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 N52group 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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K23DE031807 | NIH | None | httpsreporternihgovquickSearchK23DE031807 |