Clinical Trials Directory

Trials / Completed

CompletedNCT05868460

Laser Therapy on TMJ Disorders After Head and Neck Cancer.

Impact of High Intensity Laser Therapy on Temporomandibular Joint Disorders After Head and Neck Cancer.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Cairo University · Academic / Other
Sex
All
Age
20 Years – 60 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DEVICEHigh intensity laserpatients 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.
OTHERtraditional physical therapy exercise programpassive and active ROM exercises, stretching and strengthening exercises for 35 minutes, 3 days/ week for 4 weeks.
DEVICEplacebo High intensity laserpatients will receive placebo HILT including the same treatment as in group A but the laser device will be turned off.

Timeline

Start date
2023-05-21
Primary completion
2024-12-01
Completion
2025-02-10
First posted
2023-05-22
Last updated
2025-02-14

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT05868460. Inclusion in this directory is not an endorsement.