Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04897581
Status:
COMPLETED
Last Update Posted:
2023-06-06
First Post:
2021-05-14
Brief Title:
BBTI vs PSR in Musculoskeletal Orofacial Pain Adults
Sponsor:
Ian Boggero PhD
Organization:
University of Kentucky
Study Overview
Official Title:
Establishing the Effectiveness of BBTI vs PSR on Sleep and Pain Parameters in Adults With Musculoskeletal Orofacial Pain
Status:
COMPLETED
Status Verified Date:
2023-05
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:
BBTI_PSR_21
Brief Summary:
This clinical study aims to compare the efficacy of two brief psychological interventions Brief Behavioral Therapy for Insomnia BBIT and Physical Self-Regulation or PSR delivered over telehealth for the management of chronic musculoskeletal orofacial pain conditions local myalgia myofascial pain centrally mediated myalgia in a tertiary orofacial pain clinic It is hypothesized that both interventions will produce beneficial changes and exploratory analysis will aim to establish which intervention -if any- is better for each specific outcome
Detailed Description:
New patients who come into the orofacial pain clinic are evaluated by a dental resident and given an orofacial pain diagnosis If this primary diagnosis involves masticatory myofascial pain local myalgia or centrally-mediated myalgia and if patients self-report poor sleep they will be introduced to the study An initial evaluation for PSR and BBTI will be scheduled over telehealth If willing and eligible to participate at the end of this first evaluation they will be provided with an informed consent form and be randomly assigned to three sessions of PSR or three sessions of BBTI After providing an e-consent they will be sent a questionnaire battery on REDCap to assess their outcomes at pre-intervention A REDCap daily questionnaire will be sent every day morning and evening starting one week before session 1 of the intervention until two weeks after the last session Moreover to a small group of patients randomly selected an actigraphy watch will be mailed Two weeks after the last session of the intervention a REDCap questionnaire will be sent to assess their outcomes at post-intervention As per the current clinical protocol all participants will be offered both interventions only data from the first intervention will be utilized for the current study All PSR and BBTI sessions will be conducted via telehealth using a HIPAA-compliant zoom account
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