Laser Therapy on TMJ Disorders After Head and Neck Cancer.

NCT ID: NCT05868460

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-21
• Study Completion Date: 2025-02-10

Brief Summary

Temporomandibular disorder (TMD) is a term describing musculoskeletal conditions of the face, jaw and temporal regions. TMD is frequently associated with pain and/or dysfunction such as impaired jaw function, pain in the temporomandibular joint (TMJ), muscles and/or related structures, and associated headaches. The aetiology of TMD is multifactorial and complex.

Detailed Description

It is known that one cause of TMD symptom development is treatment for head and neck cancer (HNC). The main treatment modalities for HNC include radiotherapy (RT) with or without chemotherapy and surgical intervention, either as a single therapy or a combination therapy. In the head and neck region, the anatomical structures are necessary for essential functions such as speech, swallowing, breathing, smell, and taste. The treatment of head and neck tumours may frequently impair some of these functions, which may result in pain, oral dysfunction, and impaired health-related quality of life.

High intensity laser therapy (HILT) is a non-invasive and painless treatment method. The latest studies have reported the beneficial effects of neodymium-doped yttrium aluminum garnet (Nd: YAG) laser therapy in patients with pain. The advantage of HILT over low level laser therapy (LLLT) is that HILT is able to penetrate and stimulate wider and/or deeper areas; thus, considerably more energy may be transmitted to tissue during HILT therapy compared to LLLT.

Conditions

Temporomandibular Joint Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group A (High Intensity Laser Therapy Group)

patients will receive HILT in addition to traditional physical therapy exercise program

Group Type: EXPERIMENTAL

High intensity laser

Intervention Type: DEVICE

patients will receive Nd: YAG with wavelength 1064 nm, peak power 3KW, energy density 360-1780 mJ/cm2, a short duration 120-150 micro sec, a mean power 10.5 W, a low frequency 10-40 HZ, a duty cycle of 0.1%, a probe diameter of 0.5 cm and spot size of 0.2 cm2. The treatment will be applied into 3 phases in each session. In addition to the traditional physical therapy exercise program (passive and active ROM exercises, stretching and strengthening exercises) for 20 minutes, total session time is 35 minutes, 3 days/ week for 4 weeks.

traditional physical therapy exercise program

Intervention Type: OTHER

passive and active ROM exercises, stretching and strengthening exercises for 35 minutes, 3 days/ week for 4 weeks.

Group B (Placebo-Control Group)

patients will receive placebo HILT in addition to traditional physical therapy exercise program

Group Type: PLACEBO_COMPARATOR

traditional physical therapy exercise program

Intervention Type: OTHER

passive and active ROM exercises, stretching and strengthening exercises for 35 minutes, 3 days/ week for 4 weeks.

placebo High intensity laser

Intervention Type: DEVICE

patients will receive placebo HILT including the same treatment as in group A but the laser device will be turned off.

Interventions

High intensity laser

patients will receive Nd: YAG with wavelength 1064 nm, peak power 3KW, energy density 360-1780 mJ/cm2, a short duration 120-150 micro sec, a mean power 10.5 W, a low frequency 10-40 HZ, a duty cycle of 0.1%, a probe diameter of 0.5 cm and spot size of 0.2 cm2. The treatment will be applied into 3 phases in each session. In addition to the traditional physical therapy exercise program (passive and active ROM exercises, stretching and strengthening exercises) for 20 minutes, total session time is 35 minutes, 3 days/ week for 4 weeks.

Intervention Type: DEVICE

traditional physical therapy exercise program

passive and active ROM exercises, stretching and strengthening exercises for 35 minutes, 3 days/ week for 4 weeks.

Intervention Type: OTHER

placebo High intensity laser

patients will receive placebo HILT including the same treatment as in group A but the laser device will be turned off.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patients with temporomandibular joint disorders (myofascial pain, trismus and limitation of ROM) after head and neck cancer, patients will be diagnosed by an experienced oral and maxillofacial surgeon.

2. Patients with 20 to 60 years old.

3. 6 months after ending radiotherapy.

Exclusion Criteria

1. Patients with implants.

2. Current metastasis.

3. Continuing radiotherapy.

4. Pregnant females.

5. Sensitivity to phototherapy.

6. Bells palsy.

7. Subjects with disk displacement, arthralgia or osteoarthritis at TMJ.

8. Subjects who received analgesics or antidepressants.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Nesma Morgan Allam

Assistant Professor of physical therapy for surgery, Faculty of physical therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hadaya M Eladl, PhD

Role: STUDY_DIRECTOR

Assisstant professor of physical therapy for surgery, Faculty of physical therapy

Locations

Faculty of Physical Therapy

Giza, , Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/004499

Identifier Type: -

Identifier Source: org_study_id