Laser Therapy on TMJ Disorders After Head and Neck Cancer.

Not Applicable

Completed

• Conditions: Temporomandibular Joint Disorders
• Interventions: Device: High intensity laser; Other: traditional physical therapy exercise program; Device: placebo High intensity laser

• Registration Number: NCT05868460
• Lead Sponsor: Cairo University

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.

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-10
• Study First Submitted QC: 2023-05-18
• Study Start: 2023-05-21
• Study First Posted: 2023-05-22
• Primary Completion: 2024-12-01
• Study Completion: 2025-02-10
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (High Intensity Laser Therapy Group)	traditional physical therapy exercise program	patients will receive HILT in addition to traditional physical therapy exercise program
Group B (Placebo-Control Group)	traditional physical therapy exercise program	patients will receive placebo HILT in addition to traditional physical therapy exercise program
Group B (Placebo-Control Group)	placebo High intensity laser	patients will receive placebo HILT in addition to traditional physical therapy exercise program
Group A (High Intensity Laser Therapy Group)	High intensity laser	patients will receive HILT in addition to traditional physical therapy exercise program

Primary Outcome Measures

Name	Time	Method
Pain intensity	4 weeks	It will be measured by visual analogue scale. It starts with no pain at the left side and gradually increasing pain towards the end of the line at the right side (0-10) and high scores indicate greater pain.

Secondary Outcome Measures

Name	Time	Method
Quality of life (Oral health Impact Profile)	4 weeks	By using the Oral health Impact Profile consisted of 7 different domains (functional limitation, physical pain, psychological discomfort, psychological disability, physical disability, social disability, and handicap). Each domain was assessed by two questions, scored using a 5-point Likert scale (0 = never to 4 = very often). The total score was derived by a summing of the domain scores, it can range from 0 to 56. A higher score indicates a poorer quality of life.
Muscle power assessment	4 weeks	Surface electromyography (EMG) will be used to evaluate the strength of the masseter and anterior temporal muscles
Functional disability	4 weeks	It will be measured by jaw functional limitation scale-20. It has a score range of 1 to 200, and high scores indicate worsening jaw function.
Range of motion	4 weeks	Range of motion of temporomandibular joint will be measured by Vernier caliper scale

Trial Locations

Locations (1)

Faculty of Physical Therapy; 🇪🇬 Giza, Egypt