The Effect of Body Awareness Therapy on Pain, Function and Psychosocial Parameters in Temporomandibular Joint Disorders (BAT-TMJ)

January 31, 2026 updated by: Seda Karaca, Recep Tayyip Erdogan University

A Randomized, Single-Blind Controlled Trial Investigating the Effect of Body Awareness Therapy on Pain, Functional Outcomes, and Psychosocial Parameters in Adults With Temporomandibular Joint Disorders

This randomized, single-blind controlled trial aims to investigate the effectiveness of Body Awareness Therapy (BAT) on pain, functional limitations, and psychosocial outcomes in individuals with temporomandibular joint disorders (TMD). TMD is characterized by orofacial pain, impaired jaw function, and increased psychosocial burden, yet current physiotherapy approaches may not fully address the biopsychosocial mechanisms underlying these symptoms. BAT is a structured mind-body physiotherapy intervention designed to improve postural awareness, interoceptive sensitivity, breathing regulation, and movement control.

In this study, participants will be randomly assigned to either BAT or a standard physiotherapy control intervention for a defined treatment period. Primary outcomes will include pain intensity and jaw functional limitations, while secondary outcomes will assess body awareness, anxiety, stress, and quality of life. Evaluations will be conducted at baseline and post-intervention. The findings of this trial may provide evidence for integrating biopsychosocial and awareness-based physiotherapy into TMD rehabilitation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Adults aged 18-65 years. Diagnosed with Temporomandibular Joint Disorders (TMD) according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).

Experiencing orofacial pain or jaw functional limitation for at least the past 3 months.

Ability to understand and follow verbal instructions required for Body Awareness Therapy sessions.

Willingness to participate in the study and to attend all assessment and intervention sessions.

Providing written informed consent.

Exclusion Criteria:

History of jaw trauma, fracture, or surgery within the past 6 months. Presence of systemic rheumatologic or inflammatory disorders (e.g., rheumatoid arthritis, ankylosing spondylitis) that may affect TMJ function.

Neurological or psychiatric conditions that could interfere with participation or outcome assessments (e.g., major psychiatric disorder, cognitive impairment).

Severe dental or orthodontic conditions requiring immediate treatment (e.g., acute infection, ongoing orthodontic procedures).

Use of occlusal splints, bite guards, or other TMJ-related interventions initiated within the past 3 months.

Participation in any other physiotherapy or exercise program targeting the jaw, cervical spine, or posture during the study period.

Pregnancy, due to potential changes in joint laxity and pain perception. Current use of medications affecting neuromuscular or pain responses, such as muscle relaxants, corticosteroids, or neuropathic pain medications (unless dose has been stable for 3 months).

Any contraindication to performing light-to-moderate physical activity or awareness-based exercises.

Inability to attend scheduled therapy sessions or complete study assessments.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Body Awareness Therapy (BAT)
Participants will receive Body Awareness Therapy
Behavioral: Body Awareness Therapy
Body Awareness Therapy
Other: Standard Physiotherapy
Standard Physiotherapy
Other: Standard Physiotherapy
Participants will receive standard physiotherapy
Other: Standard Physiotherapy
Standard Physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Jaw Functional Limitation Scale (JFLS)
Time Frame: Baseline, post-intervention (8 weeks)
Jaw functional limitation assessed by the Jaw Functional Limitation Scale (JFLS). Change in jaw-related functional limitation measured using the Jaw Functional Limitation Scale (JFLS), a validated self-report questionnaire assessing limitations in mastication, jaw mobility, and verbal communication. The total score ranges from 0 to 200, with higher scores indicating greater functional limitation (worse outcome).
Baseline, post-intervention (8 weeks)
Hospital Anxiety and Depression Scale
Time Frame: Baseline, post-intervention (8 weeks)
Change in anxiety and depression levels measured using the Hospital Anxiety and Depression Scale (HADS), a validated 14-item self-report questionnaire. The anxiety (HADS-A) and depression (HADS-D) subscales are each scored from 0 to 21, with higher scores indicating greater symptom severity (worse outcome).
Baseline, post-intervention (8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Recep Tayyip Erdogan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2025

Primary Completion (Estimated)

March 20, 2026

Study Completion (Estimated)

May 20, 2026

Study Registration Dates

First Submitted

December 7, 2025

First Submitted That Met QC Criteria

December 18, 2025

First Posted (Actual)

January 5, 2026

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

January 31, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/457

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to privacy concerns and institutional ethical restrictions. The study involves sensitive health information, and the ethics committee approval covers data use only within the scope of this research. De-identified datasets cannot be made publicly available to ensure participant confidentiality is maintained.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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