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Trial Title:
Laser Therapy on TMJ Disorders After Head and Neck Cancer.
NCT ID:
NCT05868460
Condition:
Temporomandibular Joint Disorders
Conditions: Official terms:
Head and Neck Neoplasms
Joint Diseases
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Conditions: Keywords:
High Intensity Laser Therapy
Temporomandibular Joint Disorders
Head And Neck Cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Device
Intervention name:
High intensity laser
Description:
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.
Arm group label:
Group A (High Intensity Laser Therapy Group)
Intervention type:
Other
Intervention name:
traditional physical therapy exercise program
Description:
passive and active ROM exercises, stretching and strengthening exercises for 35 minutes,
3 days/ week for 4 weeks.
Arm group label:
Group A (High Intensity Laser Therapy Group)
Arm group label:
Group B (Placebo-Control Group)
Intervention type:
Device
Intervention name:
placebo High intensity laser
Description:
patients will receive placebo HILT including the same treatment as in group A but the
laser device will be turned off.
Arm group label:
Group B (Placebo-Control Group)
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.
Criteria for 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.
Gender:
All
Minimum age:
20 Years
Maximum age:
60 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Faculty of Physical Therapy
Address:
City:
Giza
Zip:
12111
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Nesma M Allam, PhD
Phone:
+201281968332
Email:
dr.nesma2011@yahoo.com
Start date:
May 21, 2023
Completion date:
April 30, 2024
Lead sponsor:
Agency:
Cairo University
Agency class:
Other
Source:
Cairo University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05868460
