Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06186817
Status:
RECRUITING
Last Update Posted:
2024-01-02
First Post:
2023-12-17
Brief Title:
Effectiveness of the Fascial Distortion Model on the Cervical Spine in Individuals with Temporomandibular Disorder
Sponsor:
Hacettepe University
Organization:
Hacettepe University
Study Overview
Official Title:
Effectiveness of Manual Therapy Based on the Fascial Distortion Model on the Cervical Spine in Individuals with Temporomandibular Disorder
Status:
RECRUITING
Status Verified Date:
2024-07
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:
The goal of this randomized clinical trial is to investigate the effectiveness of Manual Therapy Based on the Fascial Distortion Model FDM on the cervical spine by comparing it with Core Stabilization Training CST or Control in individuals with temporomandibular disorders The main questions it aims to answer are
Is the effectiveness of the addition of FDM-based Manual Therapy to conventional therapy different from the addition of CST or control Is the effectiveness of the addition of CST to conventional therapy different from the addition of FDM or control All participants in the intervention groups will be given eight-week conventional therapy Rocabado Exercises and Patient Education in addition to FDM-based Manual Therapy or CST Participants in the control group will not be given any therapy during the study
Neck pain intensity hand grip strength head posture cervical muscle performance cervical range of motion function disability and quality of life will be assessed
Is the effectiveness of the addition of FDM-based Manual Therapy to conventional therapy different from the addition of CST or control Is the effectiveness of the addition of CST to conventional therapy different from the addition of FDM or control All participants in the intervention groups will be given eight-week conventional therapy Rocabado Exercises and Patient Education in addition to FDM-based Manual Therapy or CST Participants in the control group will not be given any therapy during the study
Neck pain intensity hand grip strength head posture cervical muscle performance cervical range of motion function disability and quality of life will be assessed
Detailed Description:
Interventions are needed to address neck pain intensity hand grip strength head posture cervical muscle performance cervical range of motion function disability and quality of life in individuals with temporomandibular disorder TMD This study aims to examine the effectiveness of Fascial Distortion Model-based Manual Therapy compared to Core Stabilization Training or Control in individuals with TMD over an 8-week period Individuals with TMD will be randomized into Group 1 Fascial Distortion Model-based Manual Therapy Rocabado Exercises and Patient Education Group 2 Core Stabilization Training Rocabado Exercises and Patient Education or Group 3 Control Rocabado Exercises and Patient Education will be implemented as a home program for 8 weeks while Fascial Distortion Model-based Manual Therapy and Core Stabilization Training will be conducted once a week in a clinical setting Neck pain intensity will be assessed using the Graded Chronic Pain Scale Revised and the Short-Form McGill Pain Questionnaire Hand grip strength and head posture will be assessed using a hand dynamometer and lateral photography respectively The Functional Strength Testing of the Cervical Spine and cervical range of motions will be used to assess cervical muscle performance and function respectively Disability and quality of life will be evaluated using the Neck Disability Index and the Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire All outcomes will be measured at baseline and end of the study while neck pain intensity will also undergo intermediate assessments 2nd 4th and 6th weeks
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