Temporomandibular Joint DisordersBAT-TMJNCT07317570
The Effect of Body Awareness Therapy on Pain, Function and Psychosocial Parameters in Temporomandibular Joint Disorders
A study testing Body Awareness Therapy and Standard Physiotherapy in people with Temporomandibular Joint Disorders, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- Body Awareness Therapy and Standard Physiotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2025to 20 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Guneysu Physical Therapy and Rehabilitation School
Rize
seda karaca, PHD, 444 01 99, seda.karaca@erdogan.edu.tr
About this study
Official 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
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
- Being tested
- Body Awareness Therapy, Standard Physiotherapy
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body Awareness TherapyBehavioural
Body Awareness Therapy
Standard PhysiotherapyOther
Standard Physiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Body Awareness Therapy (BAT) | Experimental | Participants will receive Body Awareness Therapy Receives: Behavioral: Body Awareness Therapy; Other: Standard Physiotherapy |
| Standard Physiotherapy | Other | Participants will receive standard physiotherapy Receives: Other: Standard Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Baseline, post-intervention (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start20 Dec 2025
- Primary completion20 Mar 2026 (estimated)
- Study completion20 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Karaca, Recep Tayyip Erdogan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07317570
- Sponsor's protocol ID
- 2025/457
- Acronym
- BAT-TMJ
- Status last verified
- Jan 2026
- First submitted
- 7 Dec 2025
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07317570
- Acronym / sponsor ID
- BAT-TMJ / 2025/457
- Conditions
- Temporomandibular Joint Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Recep Tayyip Erdogan UniversityUniversity, hospital or other
- Study start
- 20 Dec 2025 (actual)
- Primary completion
- 20 Mar 2026 (estimated)
- Study completion
- 20 May 2026 (estimated)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Body Awareness Therapy (BAT) | Experimental | Behavioral: Body Awareness Therapy, Other: Standard PhysiotherapyParticipants will receive Body Awareness Therapy |
| Standard Physiotherapy | Other | Other: Standard PhysiotherapyParticipants will receive standard physiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Body Awareness TherapyBody Awareness Therapy | Behavioural | Body Awareness Therapy (BAT) |
| Standard PhysiotherapyStandard Physiotherapy | Other | Body Awareness Therapy (BAT), Standard Physiotherapy |
Primary outcome
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).
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guneysu Physical Therapy and Rehabilitation School
Rize, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body Awareness Therapy and Standard Physiotherapy in people with Temporomandibular Joint Disorders, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Jaw Functional Limitation Scale (JFLS) (time frame: Baseline, post-intervention (8 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.