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Status unknownNCT05757024Updated Mar 7, 2023

Effect Of High Power Laser On Radiotherapy Induced Trismus.

An interventional study of high power laser therapy in Trismus, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-03-07.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2023), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Aug 2022, registered Feb 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Trismus

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03

In context

Trismus

107 studies on the registry are indexed under Trismus; 19 are open to participants now.

This study's planned enrollment of 44 is below the median of 52 across 99 interventional studies indexed under Trismus.

Browse Trismus studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Browse Cairo University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
44 participants (estimated)

Study arms

  • Experimental
    experimental group

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

    Device: high power laser therapy

  • Active comparator
    control group

    control group receive traditional tempromadibular joint exercises.

    Device: high power laser therapy

Interventions

  • Devicehigh power laser therapy

    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

06

What researchers measure

Primary outcomes

  1. pain level

    visual analogue scale

    Time frame: one month (4 weeks)

  2. mouth opening

    verneir caliper

    Time frame: one month (4 weeks)

Secondary outcomes

  1. quality of life improvement

    Washington quality of life questionnaire

    Time frame: one month (4 weeks)

07

Study locations

1 of 1 sites recruiting
  • Faculty of Physical Therapy Cairo University
    Cairo, Egypt
    Recruiting
08

References and documents

Publications

  • 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. PubMed 26984249 ↗
  • Borges, Marcela Maria Fontes, et al.

Individual participant data

Plan to share: Undecided — study limitations and recommendations

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2022 (actual). Primary completion is estimated for Apr 2023, 8 months after the start.

Of 57 non-industry interventional studies with no phase under Trismus, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 21. This study's planned 8 months is close to that.

Counting every sponsor, half of 58 studies reached it within 8 months; a quarter within 4 and three quarters within 21.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 24, 2023
First posted
Mar 7, 2023
StartActual
Aug 2, 2022
Primary completionEst.
Apr 30, 2023
CompletionEst.
May 31, 2023
Last update
Mar 7, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05757024
Lead sponsor
Cairo University
Responsible party
Amira Hassan Abdel Twab Hussein (doctor of physical therapy, Cairo University) — Principal investigator
First posted
Mar 7, 2023
Start date
Aug 2, 2022
Primary completion
Apr 30, 2023 (estimated)
Completion
May 31, 2023 (estimated)
Last update
Mar 7, 2023

Study contacts

Amira Hassan AbdelTwab, bachelor
Contact
amirapt21594@gmail.com
01015598395
Ehab Saad Abdelnaby, M.D
Contact
ehab.saad239@gmail.com
01143650739
Mohammed Hussein Elgendy, proffessor
study director · Faculty of physiacl therapy cairo university

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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