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

NCT07026617 | Not Yet Recruiting

• 1 other identifier: LLLT and myogenic TMJ
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Myogenic Temporomandibular Joint Disorders

Outcome Measures

Primary Outcomes (1)

• 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).

  change from base line at 6 weeks.

Secondary Outcomes (3)

• Assessment of Temporomandibular joint ROM

  change from base line at 6 weeks.

• Assessment of the function of Temporomandibular Joints

  change from base line at 6 weeks.

• Assessment of pain intensity using Numerical Rating Scale

  change from base line at 6 weeks.

Study Arms (2)

study group

EXPERIMENTAL

Other: Rocabado's approach in addition to LLLT

control group

PLACEBO COMPARATOR

Other: control group

Interventions

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).

study group

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).

control group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• (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

You may not qualify if:

• (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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistance professor doctor

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 18, 2025
• Study Start: June 20, 2025
• Primary Completion: September 20, 2025
• Study Completion: October 20, 2025
• Last Updated: June 18, 2025

Record last verified: 2025-06