NCT05868460

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

May 21, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 22, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2025

Completed
Last Updated

February 14, 2025

Status Verified

May 1, 2023

Enrollment Period

1.5 years

First QC Date

May 10, 2023

Last Update Submit

February 12, 2025

Conditions

Temporomandibular Joint Disorders

Keywords

High Intensity Laser TherapyTemporomandibular Joint DisordersHead And Neck Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 weeks

Secondary Outcomes (4)

  • Range of motion

    4 weeks

  • Muscle power assessment

    4 weeks

  • Functional disability

    4 weeks

  • Quality of life (Oral health Impact Profile)

    4 weeks

Study Arms (2)

Group A (High Intensity Laser Therapy Group)

EXPERIMENTAL

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

Device: High intensity laserOther: traditional physical therapy exercise program

Group B (Placebo-Control Group)

PLACEBO COMPARATOR

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

Other: traditional physical therapy exercise programDevice: placebo High intensity laser

Interventions

High intensity laserDEVICE

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.

Group A (High Intensity Laser Therapy Group)
traditional physical therapy exercise programOTHER

passive and active ROM exercises, stretching and strengthening exercises for 35 minutes, 3 days/ week for 4 weeks.

Group A (High Intensity Laser Therapy Group)Group B (Placebo-Control Group)
placebo High intensity laserDEVICE

patients will receive placebo HILT including the same treatment as in group A but the laser device will be turned off.

Group B (Placebo-Control Group)

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.
  • months after ending radiotherapy.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy

Giza, 12111, Egypt

Location

MeSH Terms

Conditions

Temporomandibular Joint DisordersHead and Neck Neoplasms

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesNeoplasms by SiteNeoplasms

Study Officials

  • Hadaya M Eladl, PhD

    Assisstant professor of physical therapy for surgery, Faculty of physical therapy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of physical therapy for surgery, Faculty of physical therapy

Study Record Dates

First Submitted

May 10, 2023

First Posted

May 22, 2023

Study Start

May 21, 2023

Primary Completion

December 1, 2024

Study Completion

February 10, 2025

Last Updated

February 14, 2025

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share

Study results

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
6 months after publication
Access Criteria
Study protocol

Locations

EG(1)