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NCT Number: NCT07026617

Low Level Laser Therapy and Rocabado's Approach for Myogenic TMJ Disorders

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.

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Key information

Conditions

Myogenic Temporomandibular Joint Disorders

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

(1) 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

Exclusion criteria

(1) 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.

Treatment and study plan

Rocabado's approach in addition to LLLT

Other

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 Group

Other

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).

Primary outcomes

  1. 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).

Secondary outcomes

  1. Assessment of Temporomandibular joint ROM

    Time frame: change from base line at 6 weeks.

    A therabite will be used to measure mandibular opening

  2. Assessment of the function of Temporomandibular Joints

    Time frame: change from base line at 6 weeks.

    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.

  3. Assessment of pain intensity using Numerical Rating Scale

    Time frame: change from base line at 6 weeks.

    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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effectiveness of Adding Low Level Laser Therapy to Rocabado's Approach for Myogenic Temporomandibular Joint Disorders: A Double-Blind Placebo-Controlled Clinical Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 18, 2025
Registry last updated
Jun 18, 2025

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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