Effect Of High Power Laser On Radiotherapy Induced Trismus.

NCT ID: NCT05757024

Last Updated: 2023-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-02

Study Completion Date

2023-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Trismus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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experimental group

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

Group Type EXPERIMENTAL

high power laser therapy

Intervention Type DEVICE

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

control group

control group receive traditional tempromadibular joint exercises.

Group Type ACTIVE_COMPARATOR

high power laser therapy

Intervention Type DEVICE

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

Interventions

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high power laser therapy

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

Intervention Type DEVICE

Other Intervention Names

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conventional tempromandibular joint exercises

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Amira Hassan Abdel Twab Hussein

doctor of physical therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohammed Hussein Elgendy, proffessor

Role: STUDY_DIRECTOR

Faculty of physiacl therapy cairo university

Locations

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Faculty of Physical Therapy Cairo University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Amira Hassan AbdelTwab, bachelor

Role: CONTACT

01015598395

Ehab Saad Abdelnaby, M.D

Role: CONTACT

01143650739

Facility Contacts

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faculty physical therapy

Role: primary

0237617691 ext. 37617693

References

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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.

Reference Type RESULT
PMID: 26984249 (View on PubMed)

Borges, Marcela Maria Fontes, et al.

Reference Type RESULT

Other Identifiers

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P.T.REC/012004161

Identifier Type: -

Identifier Source: org_study_id

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