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Effect Of High Power Laser On Radiotherapy Induced Trismus.

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05757024
Collaborator
(none)
44
Enrollment
1
Location
2
Arms
9.9
Anticipated Duration (Months)
4.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: high power laser therapy
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Effect Of High Power Laser Therapy On Radiotherapy Induced Trismus In Head And Neck Cancer Patients
Actual Study Start Date :
Aug 2, 2022
Anticipated Primary Completion Date :
Apr 30, 2023
Anticipated Study Completion Date :
May 31, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. pain level [one month (4 weeks)]

      visual analogue scale

    2. mouth opening [one month (4 weeks)]

      verneir caliper

    Secondary Outcome Measures

    1. quality of life improvement [one month (4 weeks)]

      Washington quality of life questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Physical Therapy Cairo University Cairo Egypt

    Sponsors and Collaborators

    • Cairo University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Amira Hassan Abdel Twab Hussein, doctor of physical therapy, Cairo University
    ClinicalTrials.gov Identifier:
    NCT05757024
    Other Study ID Numbers:
    • P.T.REC/012004161
    First Posted:
    Mar 7, 2023
    Last Update Posted:
    Mar 7, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Additional relevant MeSH terms:
    Trismus

    Study Results

    No Results Posted as of Mar 7, 2023