NCT05757024

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

August 2, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 7, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

March 7, 2023

Status Verified

February 1, 2023

Enrollment Period

9 months

First QC Date

February 24, 2023

Last Update Submit

February 24, 2023

Conditions

Trismus

Outcome Measures

Primary Outcomes (2)

  • pain level

    visual analogue scale

    one month (4 weeks)

  • mouth opening

    verneir caliper

    one month (4 weeks)

Secondary Outcomes (1)

  • quality of life improvement

    one month (4 weeks)

Study Arms (2)

experimental group

EXPERIMENTAL

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

Device: high power laser therapy

control group

ACTIVE COMPARATOR

control group receive traditional tempromadibular joint exercises.

Device: high power laser therapy

Interventions

high power laser therapyDEVICE

m6 laser therapy of ASA company with multilocked wave system and synchronized emission wave lengths 808 and 905 wave lengths

Also known as: conventional tempromandibular joint exercises
control groupexperimental group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy Cairo University

Cairo, Egypt

RECRUITING

Related Publications (2)

  • 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.

    PMID: 26984249RESULT

  • Borges, Marcela Maria Fontes, et al.

    RESULT

MeSH Terms

Conditions

Trismus

Condition Hierarchy (Ancestors)

SpasmNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mohammed Hussein Elgendy, proffessor

    Faculty of physiacl therapy cairo university

    STUDY DIRECTOR

Central Study Contacts

Amira Hassan AbdelTwab, bachelor

CONTACT

01015598395amirapt21594@gmail.com

Ehab Saad Abdelnaby, M.D

CONTACT

01143650739ehab.saad239@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor of physical therapy

Study Record Dates

First Submitted

February 24, 2023

First Posted

March 7, 2023

Study Start

August 2, 2022

Primary Completion

April 30, 2023

Study Completion

May 31, 2023

Last Updated

March 7, 2023

Record last verified: 2023-02

Locations

EG(1)