Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06627855
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-03
Brief Title:
Effectiveness of the Fascial Distortion Model in Temporomandibular Disorders A Randomized Sham-controlled Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Investigation of the Effectiveness of Manual Therapy Based on Fascial Distortion Model in Individuals With Temporomandibular Disorder A Randomized Sham-controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the study was to investigate the effectiveness of Manual Therapy Based on the Fascial Distortion Model in individuals with temporomandibular disorders compared to sham control Individuals diagnosed with temporomandibular disorder will be randomly assigned to groups as Group 1 Manual Therapy Based on Fascial Distortion Model and Group 2 Sham Control Head posture cervical and temporomandibular joint range of motion cervical muscle performance pain intensity pressure pain thresholds temporomandibular disorder severity disability dysfunction health-related quality of life kinesiophobia and central sensitization will be assessed
Detailed Description:
Interventions are needed to address head posture cervical and temporomandibular joint range of motion cervical muscle performance pain intensity pressure pain thresholds temporomandibular disorder severity disability dysfunction health-related quality of life kinesiophobia and central sensitization in individuals with temporomandibular disorder TMD This study aims to examine the effectiveness of Manual Therapy Based on the Fascial Distortion Model in individuals with TMDs compared to sham control over a 4-week period Individuals with TMD will be randomized into Group 1 Fascial Distortion Model-based Manual Therapy or Group 2 Sham Control Interventions will be conducted once a week in a clinical setting Head posture will be measured by lateral photogrammetry cervical range of motion will be measured by an inclinometer temporomandibular range of motion will be measured by a vernier caliper cervical muscle performance will be measured by Cervical Spine Functional Strength Test and pressure pain threshold will be measured by an algometer Pain intensity will be assessed using the Graded Chronic Pain Scale Revised and the Short-Form McGill Pain Questionnaire TMD severity will be assessed using the Fonseca Anamnestic Index Mandibular Function Impairment Questionnaire will be used to assess dysfunction Disability will be evaluated using the Craniofacial Pain and Disability Inventory Health-related quality of life will be assessed using Short Form-36 Kinesiophobia will be assessed with the Tampa Kinesiophobia Scale central sensitization will be assessed with the Central Sensitisation Inventory
All outcomes will be measured at baseline and end of the study while pain intensity and pressure pain thresholds will also undergo intermediate assessments 2nd and 3rd week
All outcomes will be measured at baseline and end of the study while pain intensity and pressure pain thresholds will also undergo intermediate assessments 2nd and 3rd week
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None