The Effect of Body Awareness Therapy on Pain, Function and Psychosocial Parameters in Temporomandibular Joint Disorders

NCT07317570 | Recruiting

• 1 other identifier: 2025/457
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Temporomandibular Joint Disorders

Outcome Measures

Primary Outcomes (2)

• Jaw Functional Limitation Scale (JFLS)

  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

  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)

Study Arms (2)

Body Awareness Therapy (BAT)

EXPERIMENTAL

Participants will receive Body Awareness Therapy

Behavioral: Body Awareness Therapy; Other: Standard Physiotherapy

Standard Physiotherapy

OTHER

Participants will receive standard physiotherapy

Other: Standard Physiotherapy

Interventions

Body Awareness Therapy BEHAVIORAL

Body Awareness Therapy

Body Awareness Therapy (BAT)

Standard Physiotherapy OTHER

Standard Physiotherapy

Body Awareness Therapy (BAT); Standard Physiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Recep Tayyip Erdogan University: lead

Study Sites (1)

Guneysu Physical Therapy and Rehabilitation School

Rize, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Doctor Lecturer

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: January 5, 2026
• Study Start: December 20, 2025
• Primary Completion: March 20, 2026
• Study Completion (Estimated): May 20, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)