Clinical trial NCT05868460: Laser Therapy on TMJ Disorders After Head and Neck Cancer.
Official title: Impact of High Intensity Laser Therapy on Temporomandibular Joint Disorders After Head and Neck Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Joint Disorders
Keywords: High Intensity Laser Therapy
Temporomandibular Joint Disorders
Head And Neck Cancer
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain intensity
timeFrame: 4 weeks
Secondary outcomes:
measure: Range of motion
timeFrame: 4 weeks
measure: Muscle power assessment
timeFrame: 4 weeks
measure: Functional disability
timeFrame: 4 weeks
measure: Quality of life (Oral health Impact Profile)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
affiliation: Assisstant professor of physical therapy for surgery, Faculty of physical therapy
name: Hadaya M Eladl, PhD
role: STUDY_DIRECTOR
References: