Back to resultsEffect Of High Power Laser On Radiotherapy Induced Trismus.
Primary Purpose
Trismus
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
high power laser therapy
Sponsored by
About this trial
This is an interventional treatment trial for Trismus
Eligibility Criteria
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.
Sites / Locations
- Faculty of Physical Therapy Cairo UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
experimental group
control group
Arm Description
study group receive high power laser therapy in combination with conventional tempromandibular joint exercises.
control group receive traditional tempromadibular joint exercises.
Outcomes
Primary Outcome Measures
pain level
visual analogue scale
mouth opening
verneir caliper
Secondary Outcome Measures
quality of life improvement
Washington quality of life questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05757024
Brief Title
Effect Of High Power Laser On Radiotherapy Induced Trismus.
Official Title
Effect Of High Power Laser Therapy On Radiotherapy Induced Trismus In Head And Neck Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
May 31, 2023 (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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trismus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Description
study group receive high power laser therapy in combination with conventional tempromandibular joint exercises.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
control group receive traditional tempromadibular joint exercises.
Intervention Type
Device
Intervention Name(s)
high power laser therapy
Other Intervention Name(s)
conventional tempromandibular joint exercises
Intervention Description
m6 laser therapy of ASA company with multilocked wave system and synchronized emission wave lengths 808 and 905 wave lengths
Primary Outcome Measure Information:
Title
pain level
Description
visual analogue scale
Time Frame
one month (4 weeks)
Title
mouth opening
Description
verneir caliper
Time Frame
one month (4 weeks)
Secondary Outcome Measure Information:
Title
quality of life improvement
Description
Washington quality of life questionnaire
Time Frame
one month (4 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amira Hassan AbdelTwab, bachelor
Phone
01015598395
Email
amirapt21594@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ehab Saad Abdelnaby, M.D
Phone
01143650739
Email
ehab.saad239@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed Hussein Elgendy, proffessor
Organizational Affiliation
Faculty of physiacl therapy cairo university
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Physical Therapy Cairo University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
faculty physical therapy
Phone
0237617691
Ext
37617693
Email
eth.com@pt.cu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
study limitations and recommendations
Citations:
PubMed Identifier
26984249
Citation
Zecha JA, Raber-Durlacher JE, Nair RG, Epstein JB, Elad S, Hamblin MR, Barasch A, Migliorati CA, Milstein DM, Genot MT, Lansaat L, van der Brink R, Arnabat-Dominguez J, van der Molen L, Jacobi I, van Diessen J, de Lange J, Smeele LE, Schubert MM, Bensadoun RJ. Low-level laser therapy/photobiomodulation in the management of side effects of chemoradiation therapy in head and neck cancer: part 2: proposed applications and treatment protocols. Support Care Cancer. 2016 Jun;24(6):2793-805. doi: 10.1007/s00520-016-3153-y. Epub 2016 Mar 17.
Results Reference
result
Citation
Borges, Marcela Maria Fontes, et al.
Results Reference
result
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Effect Of High Power Laser On Radiotherapy Induced Trismus.
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