Effect Of High Power Laser On Radiotherapy Induced Trismus.

February 24, 2023 updated by: Amira Hassan Abdel Twab Hussein, Cairo University

Effect Of High Power Laser Therapy On Radiotherapy Induced Trismus In Head And Neck Cancer Patients

this study Randomized controlled study will be conducted to study (the effect of high power laser therapy on radiotherapy induced trismus in head and neck cancer patients).

the study group will receive high power laser therapy in combination with conventional tempromandibular joint exercises.

the control group will receive conventional tempromandibular joint exercises.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Faculty of Physical Therapy Cairo University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • head and neck cancer patients who complain of decreased mouth opening and received or receiving radiotherapy.
  • patients who complain from pain and inflammation in the tempromandibular joint due to radiotherapy.
  • radiotherapy should be above 40 GY.
  • patient ages between 20 to 65 years old.

Exclusion Criteria:

  • patients with poor general health.
  • patients with difficulties in filling questionnaire.
  • patients who are complaining of other tempomandibular problems other than trismus such as (disc discplacement and trumatic mandibular fractures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
study group receive high power laser therapy in combination with conventional tempromandibular joint exercises.
Device: high power laser therapy
m6 laser therapy of ASA company with multilocked wave system and synchronized emission wave lengths 808 and 905 wave lengths
Other Names:
  • conventional tempromandibular joint exercises
Active Comparator: control group
control group receive traditional tempromadibular joint exercises.
Device: high power laser therapy
m6 laser therapy of ASA company with multilocked wave system and synchronized emission wave lengths 808 and 905 wave lengths
Other Names:
  • conventional tempromandibular joint exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain level
Time Frame: one month (4 weeks)
visual analogue scale
one month (4 weeks)
mouth opening
Time Frame: one month (4 weeks)
verneir caliper
one month (4 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of life improvement
Time Frame: one month (4 weeks)
Washington quality of life questionnaire
one month (4 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Mohammed Hussein Elgendy, proffessor, Faculty of physiacl therapy cairo university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2022

Primary Completion (Anticipated)

April 30, 2023

Study Completion (Anticipated)

May 31, 2023

Study Registration Dates

First Submitted

February 24, 2023

First Submitted That Met QC Criteria

February 24, 2023

First Posted (Estimate)

March 7, 2023

Study Record Updates

Last Update Posted (Estimate)

March 7, 2023

Last Update Submitted That Met QC Criteria

February 24, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012004161

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

study limitations and recommendations

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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