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NCT Number: NCT07317570

The Effect of Body Awareness Therapy on Pain, Function and Psychosocial Parameters in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guneysu Physical Therapy and Rehabilitation School

Rize, Turkey (Türkiye)

Location status: Recruiting

Location contact

seda karaca, PHD

CONTACT

[email protected]

444 01 99

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Body Awareness Therapy

Behavioral

Body Awareness Therapy

Standard Physiotherapy

Other

Standard Physiotherapy

Primary outcomes

  1. 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).

  2. 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).

Sponsors and collaborators

Lead sponsor

Recep Tayyip Erdogan University

Other

Registry information

Official study title

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

Acronym: BAT-TMJ

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 5, 2026
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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