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Efficacy of Manual Therapy Based on the Fascial Distortion Model in Individuals With Temporomandibular Disorder

H

Hacettepe University

Status

Completed

Conditions

Temporomandibular Joint Pain
Temporomandibular Joint Disorders
Temporomandibular Joint Disc Displacement
Temporomandibular Joint Dysfunction Syndrome
Temporomandibular Disorder
Manual Therapy

Treatments

Behavioral: Patient Education
Procedure: Rocabado's 6x6 Exercises
Procedure: Fascial Distortion Model
Procedure: Core Stabilization Training

Study type

Interventional

Funder types

Other

Identifiers

NCT06134310
00002755468
1649B032002402 (Other Grant/Funding Number)

Details and patient eligibility

About

The goal of this randomized clinical trial is to investigate the efficacy of Manual Therapy Based on the Fascial Distortion Model (FDM) 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 efficacy of the addition of FDM-based Manual Therapy to conventional therapy different from the addition of CST or control?
  • Is the efficacy 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.

Pain intensity, TMD severity, head posture, function, and disability will be assessed.

Full description

Interventions are needed to address pain intensity, temporomandibular disorder severity, head posture, function, and disability levels in individuals with temporomandibular disorder (TMD). This study aims to examine the efficacy 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. Pain intensity will be assessed using the Graded Chronic Pain Scale (Revised) and the Short-Form McGill Pain Questionnaire. TMD severity and head posture will be assessed using the Fonseca Anamnestic Index and lateral photography, respectively. Mandibular Function Impairment Questionnaire and temporomandibular joint range of motions will be used to assess function. Disability will be evaluated using the Craniomandibular Pain and Disability Inventory and the Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire. All outcomes will be measured at baseline and end of the study, while pain intensity will also undergo intermediate assessments (2nd, 4th, and 6th weeks).

Enrollment

53 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Having a temporomandibular joint complaint that has persisted for three months
  • Being diagnosed with temporomandibular disorder according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Axis I
  • Comprehension and interest in responding to assessment questions

Exclusion criteria

  • Having a systemic condition (neurological, rheumatological, oncological, etc.) that could affect the temporomandibular joint and/or interfere with the evaluation
  • History of any trauma that may have affected cranial, cervical, or facial region
  • Having undergone any surgical intervention in cranial, cervical, or facial region in the previous six months
  • Receiving any surgical treatment, medical treatment or physiotherapy for temporomandibular disorder in the last month
  • Having received radiotherapy in the cranial or cervical region
  • Pregnancy or breastfeeding
  • Exercise for head posture for the last month

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

53 participants in 3 patient groups

Manual Therapy based Fascial Distortion Model
Active Comparator group
Description:
All participants were given manual therapy based on the Fascial Distortion Model in addition to conventional therapy (Rocabado's 6x6 Exercises and Patient Education). Conventional therapy was implemented as a home program for 8 weeks, while Manual Therapy was conducted for forty-five minutes once a week in a clinical setting.
Treatment:
Procedure: Fascial Distortion Model
Procedure: Rocabado's 6x6 Exercises
Behavioral: Patient Education
Core Stabilization Training
Active Comparator group
Description:
All participants were given manual therapy based on the Core Stabilization Training in addition to conventional therapy (Rocabado's 6x6 Exercises and Patient Education). Conventional therapy was implemented as a home program for 8 weeks, while Core Stabilization Training was conducted for forty-five minutes once a week in a clinical setting.
Treatment:
Procedure: Core Stabilization Training
Procedure: Rocabado's 6x6 Exercises
Behavioral: Patient Education
Control
No Intervention group
Description:
No participant was given any therapy during the study.

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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