Myogenic Temporomandibular Joint DisordersNCT07026617
Low Level Laser Therapy and Rocabado's Approach for Myogenic TMJ Disorders
A study testing Rocabado's approach in addition to LLLT in people with Myogenic Temporomandibular Joint Disorders, run by Cairo University.
Trial summary
Rocabado's 6x6 exercises are designed to improve muscular co-ordination, relax tense muscles, increase temporomandibular joint (TMJ) ROM, alter the jaw closure pattern and muscle strength. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Myogenic Temporomandibular Joint Disorders
- What is being tested?
- Rocabado's approach in addition to LLLT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2025to 20 Oct 2025
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The patient's ages ranged from 18 to 40 years ; (2) having symptoms of TMD for at least twelve weeks duration established by expert physician or orthopaedician; (3) mouth opening < 25mm
Who cannot join
- TMJ fracture undergone any surgical procedure for TMJ; (2) Fracture surrounding TMJ; (3) Dislocation or subluxation of TMJ; (4) Systemic generalized joint diseases, such as rheumatoid arthritis, and osteoporosis, congenital diseases or facial paralysis; (5) recently any dental treatment taken or surgery over TMJ; (6) Hematological cervical disorders which may affect the jaw; (7) Neurological deficits e.g. Bells palsy, Trigeminal neuralgia; (8) Recent infections (within the last six months) affecting the head and neck e.g. bone infections, meningitis, encephalitis, malaria, ear infection; (9) Participants who were using any functional appliances e.g. dentures, braces, bite appliances which had been adjusted or fitted in the last 12 weeks prior to the commencement of this study.
About this study
Official title: Effectiveness of Adding Low Level Laser Therapy to Rocabado's Approach for Myogenic Temporomandibular Joint Disorders: A Double-Blind Placebo-Controlled Clinical Trial
Rocabado's 6x6 exercises are designed to improve muscular co-ordination, relax tense muscles, increase temporomandibular joint (TMJ) ROM, alter the jaw closure pattern and muscle strength. These exercises have been found to be beneficial in reducing pain and increasing masticatory muscle function, as well as restoring restricted joint mobility, muscle length limitation, and postural and functional limitations. In addition, low level laser therapy (LLLT) has been reported to reduce inflammation and pain in patients with TMJ dysfunction. Although that to the best of the authors' knowledge the combined effect of Rocabado's approach with LLLT has not been studied. So, the current study is the first double-blind placebo-controlled clinical trial that investigating the effect of adding LLLT to Rocabado's approach for TMJ myogenic disorders.
- Being tested
- Rocabado's approach in addition to LLLT, control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocabado's approach in addition to LLLTOther
The patients will recieve Rocabado's non-thrust manipulation: Non-thrust temporo-mandibular joint manipulations consisted of medial glide, lateral glide and anterior glide as described by Rocabado. Each glide was given for 10-15 repetitions for 5-6 times in a session. The grade of mobilization was beginning with Grade-1 or 2 and progressed to Grade-4 depending on subject condition. Total duration of mobilization was lasted for 20 minutes. in addition to low power gallium aluminum arsenide (GaAlAs).
control groupOther
The patients will recieve Rocabado's non-thrust manipulation: Non-thrust temporo-mandibular joint manipulations consisted of medial glide, lateral glide and anterior glide as described by Rocabado. Each glide was given for 10-15 repetitions for 5-6 times in a session. The grade of mobilization was beginning with Grade-1 or 2 and progressed to Grade-4 depending on subject condition. Total duration of mobilization was lasted for 20 minutes. in addition to lplacebo ow power gallium aluminum arsenide (GaAlAs).
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Not described Receives: Other: Rocabado's approach in addition to LLLT |
| control group | Placebo comparator | Not described Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Pain pressure threshold of masticatory muscles
The pain pressure threshold over the temporalis and masseter muscles will be assessed using an algometer with a 1 cm2 probe tip (FDIX Digital Force Gage; Wagner Instruments).
Measured: change from base line at 6 weeks.
Secondary outcomes (3)
Assessment of Temporomandibular joint ROM
A therabite will be used to measure mandibular opening
Measured: change from base line at 6 weeks.
Assessment of the function of Temporomandibular Joints
Temporomandibular Disorder Disability Questionnaire will be used for evaluating the temporomandibular joint function. It consists of the following subsections: the Temporomandibular Disorder Disability Index, Temporomandibular Disorder symptom intensity scale, and Temporomandibular Disorder symptom frequency scale.
Measured: change from base line at 6 weeks.
Assessment of pain intensity using Numerical Rating Scale
in the rating scale the patient will be asked to indicate a number between 0 and 100 on a horizontal line, that best described his/her perceived level of pain intensity when it is at its worst and when it is at is least.
Measured: change from base line at 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start20 Jun 2025 (estimated)
- Primary completion20 Sep 2025 (estimated)
- Study completion20 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myogenic Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Participant, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Shafiek Mustafa Saleh, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07026617
- Sponsor's protocol ID
- LLLT and myogenic TMJ
- Status last verified
- Jun 2025
- First submitted
- 10 Jun 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Adding Low Level Laser Therapy to Rocabado's Approach for Myogenic Temporomandibular Joint Disorders: A Double-Blind Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07026617
- Acronym / sponsor ID
- LLLT and myogenic TMJ
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Jun 2025 (estimated)
- Primary completion
- 20 Sep 2025 (estimated)
- Study completion
- 20 Oct 2025 (estimated)
- First posted
- 18 Jun 2025 (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.
Rocabado's 6x6 exercises are designed to improve muscular co-ordination, relax tense muscles, increase temporomandibular joint (TMJ) ROM, alter the jaw closure pattern and muscle strength. These exercises have been found to be beneficial in reducing pain and increasing masticatory muscle function, as well as restoring restricted joint mobility, muscle length limitation, and postural and functional limitations. In addition, low level laser therapy (LLLT) has been reported to reduce inflammation and pain in patients with TMJ dysfunction. Although that to the best of the authors' knowledge the combined effect of Rocabado's approach with LLLT has not been studied. So, the current study is the first double-blind placebo-controlled clinical trial that investigating the effect of adding LLLT to Rocabado's approach for TMJ myogenic disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Other: Rocabado's approach in addition to LLLT |
| control group | Placebo comparator | Other: control group |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The patient's ages ranged from 18 to 40 years ; (2) having symptoms of TMD for at least twelve weeks duration established by expert physician or orthopaedician; (3) mouth opening < 25mm
Key exclusion criteria (1 listed)
- TMJ fracture undergone any surgical procedure for TMJ; (2) Fracture surrounding TMJ; (3) Dislocation or subluxation of TMJ; (4) Systemic generalized joint diseases, such as rheumatoid arthritis, and osteoporosis, congenital diseases or facial paralysis; (5) recently any dental treatment taken or surgery over TMJ; (6) Hematological cervical disorders which may affect the jaw; (7) Neurological deficits e.g. Bells palsy, Trigeminal neuralgia; (8) Recent infections (within the last six months) affecting the head and neck e.g. bone infections, meningitis, encephalitis, malaria, ear infection; (9) Participants who were using any functional appliances e.g. dentures, braces, bite appliances which had been adjusted or fitted in the last 12 weeks prior to the commencement of this study.
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 |
|---|---|---|
| Rocabado's approach in addition to LLLTThe patients will recieve Rocabado's non-thrust manipulation: Non-thrust temporo-mandibular joint manipulations consisted of medial glide, lateral glide and anterior glide as described by Rocabado. Each glide was given for 10-15 repetitions for 5-6 times in a session. The grade of mobilization was beginning with Grade-1 or 2 and progressed to Grade-4 depending on subject condition. Total duration of mobilization was lasted for 20 minutes. in addition to low power gallium aluminum arsenide (GaAlAs). | Other | study group |
| control groupThe patients will recieve Rocabado's non-thrust manipulation: Non-thrust temporo-mandibular joint manipulations consisted of medial glide, lateral glide and anterior glide as described by Rocabado. Each glide was given for 10-15 repetitions for 5-6 times in a session. The grade of mobilization was beginning with Grade-1 or 2 and progressed to Grade-4 depending on subject condition. Total duration of mobilization was lasted for 20 minutes. in addition to lplacebo ow power gallium aluminum arsenide (GaAlAs). | Other | control group |
Primary outcome
Assessment of Pain pressure threshold of masticatory muscles
Time frame: change from base line at 6 weeks.
The pain pressure threshold over the temporalis and masseter muscles will be assessed using an algometer with a 1 cm2 probe tip (FDIX Digital Force Gage; Wagner Instruments).
3 secondary outcomes
Assessment of Temporomandibular joint ROM
Time frame: change from base line at 6 weeks.
Assessment of the function of Temporomandibular Joints
Time frame: change from base line at 6 weeks.
Assessment of pain intensity using Numerical Rating Scale
Time frame: change from base line at 6 weeks.
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 18 Jun 2025.
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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 Rocabado's approach in addition to LLLT in people with Myogenic Temporomandibular Joint Disorders, run by Cairo 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 1 inclusion and 1 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 18 Jun 2025. 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. Some participants in this study may receive a placebo. 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?
Assessment of Pain pressure threshold of masticatory muscles (time frame: change from base line at 6 weeks.). 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 18 Jun 2025.