search
Back to results

Laser Therapy on TMJ Disorders After Head and Neck Cancer.

Primary Purpose

Temporomandibular Joint Disorders

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
High intensity laser
traditional physical therapy exercise program
placebo High intensity laser
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Disorders focused on measuring High Intensity Laser Therapy, Temporomandibular Joint Disorders, Head And Neck Cancer

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Patients with 20 to 60 years old. 6 months after ending radiotherapy. Exclusion Criteria: Patients with implants. Current metastasis. Continuing radiotherapy. Pregnant females. Sensitivity to phototherapy. Bells palsy. Subjects with disk displacement, arthralgia or osteoarthritis at TMJ. Subjects who received analgesics or antidepressants.

Sites / Locations

  • Faculty of Physical TherapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group A (High Intensity Laser Therapy Group)

Group B (Placebo-Control Group)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pain intensity
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

Range of motion
Range of motion of temporomandibular joint will be measured by Vernier caliper scale
Muscle power assessment
Surface electromyography (EMG) will be used to evaluate the strength of the masseter and anterior temporal muscles
Functional disability
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.
Quality of life (Oral health Impact Profile)
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.

Full Information

First Posted
May 10, 2023
Last Updated
May 21, 2023
Sponsor
Cairo University
search

1. Study Identification

Unique Protocol Identification Number
NCT05868460
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 21, 2023 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorders
Keywords
High Intensity Laser Therapy, Temporomandibular Joint Disorders, Head And Neck Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A (High Intensity Laser Therapy Group)
Arm Type
Experimental
Arm Description
patients will receive HILT in addition to traditional physical therapy exercise program
Arm Title
Group B (Placebo-Control Group)
Arm Type
Placebo Comparator
Arm Description
patients will receive placebo HILT in addition to traditional physical therapy exercise program
Intervention Type
Device
Intervention Name(s)
High intensity laser
Intervention 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.
Intervention Type
Other
Intervention Name(s)
traditional physical therapy exercise program
Intervention Description
passive and active ROM exercises, stretching and strengthening exercises for 35 minutes, 3 days/ week for 4 weeks.
Intervention Type
Device
Intervention Name(s)
placebo High intensity laser
Intervention Description
patients will receive placebo HILT including the same treatment as in group A but the laser device will be turned off.
Primary Outcome Measure Information:
Title
Pain intensity
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Range of motion
Description
Range of motion of temporomandibular joint will be measured by Vernier caliper scale
Time Frame
4 weeks
Title
Muscle power assessment
Description
Surface electromyography (EMG) will be used to evaluate the strength of the masseter and anterior temporal muscles
Time Frame
4 weeks
Title
Functional disability
Description
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.
Time Frame
4 weeks
Title
Quality of life (Oral health Impact Profile)
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Patients with 20 to 60 years old. 6 months after ending radiotherapy. Exclusion Criteria: Patients with implants. Current metastasis. Continuing radiotherapy. Pregnant females. Sensitivity to phototherapy. Bells palsy. Subjects with disk displacement, arthralgia or osteoarthritis at TMJ. Subjects who received analgesics or antidepressants.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nesma M Allam, PhD
Phone
+201281968332
Email
dr.nesma2011@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hadaya M Eladl, PhD
Organizational Affiliation
Assisstant professor of physical therapy for surgery, Faculty of physical therapy
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Physical Therapy
City
Giza
ZIP/Postal Code
12111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nesma M Allam, PhD
Phone
+201281968332
Email
dr.nesma2011@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Study results
IPD Sharing Time Frame
6 months after publication
IPD Sharing Access Criteria
Study protocol

Learn more about this trial

Laser Therapy on TMJ Disorders After Head and Neck Cancer.

We'll reach out to this number within 24 hrs