Temporomandibular Joint DisordersNCT07785271
Manual Therapy vs. Home Exercise in Myogenic TMD With Neck Pain
A study testing Manual Therapy Protocol and Rocabado 6x6 Home Exercise Program in people with Temporomandibular Joint Disorders and Neck Pain Musculoskeletal, run by Pamukkale University.
Trial summary
Temporomandibular disorders (TMD) are common musculoskeletal conditions affecting the jaw joint and surrounding chewing muscles. Myogenic TMD specifically involves muscle pain and dysfunction, which is frequently accompanied by chronic neck pain due to the close anatomical and neurophysiological connections between… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Temporomandibular Joint Disorders, Neck Pain Musculoskeletal
- What is being tested?
- Manual Therapy Protocol and Rocabado 6x6 Home Exercise Program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 28 Feb 2027
- 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 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Presence of TMJ pain at rest,
- TMJ pain persisting for at least 3 months,
- Neck pain persisting for at least 3 months,
- Willingness to participate in the study.
Who cannot join
- Any orthopedic and/or neurological condition that would preclude the assessments,
- Cardiac history or surgery severe enough to preclude exercise,
- Diagnosis of any psychiatric disorder,
- Any condition precluding assessment or communication,
- History of orthopedic surgery in any region,
- Receipt of physiotherapy or any other treatment for the TMJ or spinal region within the previous 6 months,
- Illiteracy,
- A positive vertebrobasilar artery test.
About this study
Official title: Comparative Effects of Manual Therapy Versus Home Exercise on Pain, Function, and Masseter Muscle Properties in Myogenic Temporomandibular Disorder With Neck Pain: A Randomized Controlled Trial.
Temporomandibular disorders (TMD) are common musculoskeletal conditions affecting the jaw joint and surrounding chewing muscles. Myogenic TMD specifically involves muscle pain and dysfunction, which is frequently accompanied by chronic neck pain due to the close anatomical and neurophysiological connections between the jaw and the cervical spine.
The purpose of this study is to compare the clinical effectiveness of two widely used physiotherapy interventions-a clinician-administered manual therapy protocol and a patient-conducted home exercise program-in individuals diagnosed with myogenic TMD and chronic neck pain. The main research question is to determine whether targeted manual therapy applied to both the temporomandibular and cervical regions yields superior improvements in pain, jaw and neck mobility, quality of life, and masseter muscle properties compared to the Rocabado 6x6 home exercise program alone.
Read more
- A total of 34 participants aged 18-45 years with myogenic TMD and chronic neck pain will be randomly allocated into two equal groups: Manual Therapy Group: Participants receive 6 individual treatment sessions (3 days per week for 2 weeks) consisting of soft tissue mobilization, trigger point therapy, myofascial release, and joint mobilization techniques applied to the jaw and neck regions.
- Exercise Group: Participants perform the standardized Rocabado 6x6 home exercise program 3 days per week for 2 weeks, with adherence monitored through daily exercise diaries.
All participants undergo comprehensive assessments at baseline and immediately following the 2-week intervention. Evaluated parameters include jaw and neck pain intensity (Visual Analog Scale), cervical and mandibular range of motion, cervical joint position sense, jaw proprioception, facial asymmetry, bruxism, TMD severity, movement-related fear (kinesiophobia), and quality of life. In addition, masseter muscle thickness and elasticity are objectively assessed using ultrasound imaging and elastography.
The findings of this trial aim to provide healthcare professionals with high-level evidence regarding effective, targeted physiotherapy strategies for managing myogenic TMD co-occurring with cervical pain.
- Being tested
- Manual Therapy Protocol, Rocabado 6x6 Home Exercise Program
- 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.
Manual Therapy ProtocolProcedure or surgery
Clinician-administered targeted manual therapy protocol applied to both the temporomandibular joint and cervical spine regions. The treatment includes soft tissue mobilization, myofascial release, trigger point therapy, and joint mobilization techniques. Administered in 6 individual treatment sessions over 2 weeks (3 sessions per week).
Rocabado 6x6 Home Exercise ProgramOther
Standardized patient-conducted Rocabado 6x6 home exercise program focusing on mandibular and cervical posture, mobility, and muscular control. Performed 3 days per week for 2 weeks. Patient adherence and compliance are tracked using daily exercise logbooks.
| Study group | Role | What they receive |
|---|---|---|
| Manual Therapy Group | Experimental | Not described Receives: Procedure: Manual Therapy Protocol |
| Rocabado Home Exercise Group | Active comparator | Not described Receives: Other: Rocabado 6x6 Home Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temporomandibular Joint Pain Intensity at Rest, During Activity, and During Chewing Assessed by Visual Analog Scale (VAS).
Measured: Baseline and Week 2, immediately post-treatment
Title: Neck Pain Intensity Assessed by Visual Analog Scale (VAS).
Measured: Baseline and 2 weeks post-treatment
Secondary outcomes (10)
Cervical Spine Active Range of Motion Assessed by Baseline CROM Deluxe Device.
Measured: Baseline and 2 weeks post-treatmen
Cervical Joint Position Error Assessed by Baseline CROM Deluxe Device
Measured: Baseline and 2 weeks post-treatmen
Mandibular Range of Motion Assessed by Digital Caliper
Measured: Baseline and 2 weeks post-treatment
Jaw Proprioception Assessed by Active Movement Extent Discrimination Apparatus (AMEDA) Protocol.
Measured: Baseline and 2 weeks post-treatment
Facial Asymmetry Assessed by Tape Measure
Measured: Baseline and 2 weeks post-treatment
Kinesiophobia Assessed by Tampa Scale for Kinesiophobia for Temporomandibular Disorders - Short Form (TSK-TMD-12).
Measured: Baseline and 2 weeks post-treatment
Health-Related Quality of Life Assessed by 12-Item Short Form Survey (SF-12).
Measured: Baseline and 2 weeks post-treatment
Self-Reported Awake and Sleep Bruxism Assessed by Patient Questionnaire.
Measured: Baseline and 2 weeks post-treatment
Temporomandibular Disorder Severity Assessed by the Fonseca Anamnestic Index (FAI) / Fonseca Questionnaire.
Measured: Baseline and 2 weeks post-treatment
Bilateral Masseter Muscle Thickness Assessed by Ultrasonography.
Measured: Baseline and 2 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Jan 2027 (estimated)
- Study completion28 Feb 2027 (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.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Borna Farhoomand, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07785271
- Sponsor's protocol ID
- E-60116787-020-797163
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Manual Therapy Versus Home Exercise on Pain, Function, and Masseter Muscle Properties in Myogenic Temporomandibular Disorder With Neck Pain: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07785271
- Acronym / sponsor ID
- E-60116787-020-797163
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 25 Aug 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.
Temporomandibular disorders (TMD) are common musculoskeletal conditions affecting the jaw joint and surrounding chewing muscles. Myogenic TMD specifically involves muscle pain and dysfunction, which is frequently accompanied by chronic neck pain due to the close anatomical and neurophysiological connections between the jaw and the cervical spine.
The purpose of this study is to compare the clinical effectiveness of two widely used physiotherapy interventions-a clinician-administered manual therapy protocol and a patient-conducted home exercise program-in individuals diagnosed with myogenic TMD and chronic neck pain. The main research question is to determine whether targeted manual therapy applied to both the temporomandibular and cervical regions yields superior improvements in pain, jaw and neck mobility, quality of life, and masseter muscle properties compared to the Rocabado 6x6 home exercise program alone.
- A total of 34 participants aged 18-45 years with myogenic TMD and chronic neck pain will be randomly allocated into two equal groups: Manual Therapy Group: Participants receive 6 individual treatment sessions (3 days per week for 2 weeks) consisting of soft tissue mobilization, trigger point therapy, myofascial release, and joint mobilization techniques applied to the jaw and neck regions.
- Exercise Group: Participants perform the standardized Rocabado 6x6 home exercise program 3 days per week for 2 weeks, with adherence monitored through daily exercise diaries.
All participants undergo comprehensive assessments at baseline and immediately following the 2-week intervention. Evaluated parameters include jaw and neck pain intensity (Visual Analog Scale), cervical and mandibular range of motion, cervical joint position sense, jaw proprioception, facial asymmetry, bruxism, TMD severity, movement-related fear (kinesiophobia), and quality of life. In addition, masseter muscle thickness and elasticity are objectively assessed using ultrasound imaging and elastography.
The findings of this trial aim to provide healthcare professionals with high-level evidence regarding effective, targeted physiotherapy strategies for managing myogenic TMD co-occurring with cervical pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Therapy Group | Experimental | Procedure: Manual Therapy Protocol |
| Rocabado Home Exercise Group | Active comparator | Other: Rocabado 6x6 Home Exercise Program |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Presence of TMJ pain at rest,
- TMJ pain persisting for at least 3 months,
- Neck pain persisting for at least 3 months,
- Willingness to participate in the study.
Key exclusion criteria (8 listed)
- Any orthopedic and/or neurological condition that would preclude the assessments,
- Cardiac history or surgery severe enough to preclude exercise,
- Diagnosis of any psychiatric disorder,
- Any condition precluding assessment or communication,
- History of orthopedic surgery in any region,
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 |
|---|---|---|
| Manual Therapy ProtocolClinician-administered targeted manual therapy protocol applied to both the temporomandibular joint and cervical spine regions. The treatment includes soft tissue mobilization, myofascial release, trigger point therapy, and joint mobilization techniques. Administered in 6 individual treatment sessions over 2 weeks (3 sessions per week). | Procedure or surgery | Manual Therapy Group |
| Rocabado 6x6 Home Exercise ProgramStandardized patient-conducted Rocabado 6x6 home exercise program focusing on mandibular and cervical posture, mobility, and muscular control. Performed 3 days per week for 2 weeks. Patient adherence and compliance are tracked using daily exercise logbooks. | Other | Rocabado Home Exercise Group |
Primary outcome
Temporomandibular Joint Pain Intensity at Rest, During Activity, and During Chewing Assessed by Visual Analog Scale (VAS).
Time frame: Baseline and Week 2, immediately post-treatment
Title: Neck Pain Intensity Assessed by Visual Analog Scale (VAS).
Time frame: Baseline and 2 weeks post-treatment
10 secondary outcomes
Cervical Spine Active Range of Motion Assessed by Baseline CROM Deluxe Device.
Time frame: Baseline and 2 weeks post-treatmen
Cervical Joint Position Error Assessed by Baseline CROM Deluxe Device
Time frame: Baseline and 2 weeks post-treatmen
Mandibular Range of Motion Assessed by Digital Caliper
Time frame: Baseline and 2 weeks post-treatment
Jaw Proprioception Assessed by Active Movement Extent Discrimination Apparatus (AMEDA) Protocol.
Time frame: Baseline and 2 weeks post-treatment
Facial Asymmetry Assessed by Tape Measure
Time frame: Baseline and 2 weeks post-treatment
Kinesiophobia Assessed by Tampa Scale for Kinesiophobia for Temporomandibular Disorders - Short Form (TSK-TMD-12).
Time frame: Baseline and 2 weeks post-treatment
Health-Related Quality of Life Assessed by 12-Item Short Form Survey (SF-12).
Time frame: Baseline and 2 weeks post-treatment
Self-Reported Awake and Sleep Bruxism Assessed by Patient Questionnaire.
Time frame: Baseline and 2 weeks post-treatment
Temporomandibular Disorder Severity Assessed by the Fonseca Anamnestic Index (FAI) / Fonseca Questionnaire.
Time frame: Baseline and 2 weeks post-treatment
Bilateral Masseter Muscle Thickness Assessed by Ultrasonography.
Time frame: Baseline and 2 weeks post-treatment
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 25 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Therapy Protocol and Rocabado 6x6 Home Exercise Program in people with Temporomandibular Joint Disorders and Neck Pain Musculoskeletal, run by Pamukkale University.
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 4 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: opening soon, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temporomandibular Joint Pain Intensity at Rest, During Activity, and During Chewing Assessed by Visual Analog Scale (VAS). (time frame: Baseline and Week 2, immediately post-treatment). 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 25 Aug 2026.