Effect Of High Power Laser On Radiotherapy Induced Trismus.

Trismus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05757024
• Other study ID #: P.T.REC/012004161
• Status: Recruiting
• Phase: N/A
• Start date: August 2, 2022
• Est. completion date: May 31, 2023

Study information

• Verified date: February 2023
• Source: Cairo University
• Contact: Amira Hassan AbdelTwab, bachelor
• Phone: 01015598395
• Email: amirapt21594[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: May 31, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Trismus

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Borges, Marcela Maria Fontes, et al.

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, Bensadou — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain level	visual analogue scale	one month (4 weeks)
Primary	mouth opening	verneir caliper	one month (4 weeks)
Secondary	quality of life improvement	Washington quality of life questionnaire	one month (4 weeks)