TrismusNCT05757024
Effect Of High Power Laser On Radiotherapy Induced Trismus.
A study testing high power laser therapy in people with Trismus, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Trismus
- What is being tested?
- high power laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Aug 2022to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy Cairo University
Cairo
faculty physical therapy, 0237617691 ext. 37617693, eth.com@pt.cu.edu.eg
About this study
Official title: Effect Of High Power Laser Therapy On Radiotherapy Induced Trismus In Head And Neck Cancer Patients
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.
- Conditions
- Trismus
- Being tested
- high power laser therapy
- Medical subject headings
- Trismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high power laser therapyDevice
Also called conventional tempromandibular joint exercises
m6 laser therapy of ASA company with multilocked wave system and synchronized emission wave lengths 808 and 905 wave lengths
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | study group receive high power laser therapy in combination with conventional tempromandibular joint exercises. Receives: Device: high power laser therapy |
| control group | Active comparator | control group receive traditional tempromadibular joint exercises. Receives: Device: high power laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain level
visual analogue scale
Measured: one month (4 weeks)
mouth opening
verneir caliper
Measured: one month (4 weeks)
Secondary outcomes (1)
quality of life improvement
Washington quality of life questionnaire
Measured: one month (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start2 Aug 2022
- Primary completion30 Apr 2023 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TrismusStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Hassan Abdel Twab Hussein, Cairo University
- Investigators
- Mohammed Hussein Elgendy, proffessor, Study director, Faculty of physiacl therapy cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757024
- Sponsor's protocol ID
- P.T.REC/012004161
- Status last verified
- Feb 2023
- First submitted
- 24 Feb 2023
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: study limitations and recommendations
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 26984249Borges, Marcela Maria Fontes, et al.
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of High Power Laser Therapy On Radiotherapy Induced Trismus In Head And Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT05757024
- Acronym / sponsor ID
- P.T.REC/012004161
- Conditions
- Trismus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 7 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Device: high power laser therapystudy group receive high power laser therapy in combination with conventional tempromandibular joint exercises. |
| control group | Active comparator | Device: high power laser therapycontrol group receive traditional tempromadibular joint exercises. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high power laser therapyAlso: conventional tempromandibular joint exercisesm6 laser therapy of ASA company with multilocked wave system and synchronized emission wave lengths 808 and 905 wave lengths | Device | control group, experimental group |
Primary outcome
pain level
Time frame: one month (4 weeks)
visual analogue scale
mouth opening
Time frame: one month (4 weeks)
verneir caliper
1 secondary outcome
quality of life improvement
Time frame: one month (4 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Results publication: PubMed 26984249Zecha 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 publicationBorges, Marcela Maria Fontes, et al.
- Individual participant dataSharing planned: Undecided. study limitations and recommendations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammed Hussein Elgendy, proffessor study director
Faculty of physiacl therapy cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high power laser therapy in people with Trismus, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amira Hassan AbdelTwab, bachelor (01015598395, amirapt21594@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain level (time frame: one month (4 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05757024, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.