Temporomandibular Joint DisordersNCT05868460
Laser Therapy on TMJ Disorders After Head and Neck Cancer.
A study testing High intensity laser and traditional physical therapy exercise program in people with Temporomandibular Joint Disorders, run by Cairo University at 1 site in Egypt.
Trial summary
Temporomandibular disorder (TMD) is a term describing musculoskeletal conditions of the face, jaw and temporal regions. TMD is frequently associated with pain and/or dysfunction such as impaired jaw function, pain in the temporomandibular joint (TMJ), muscles and/or related structures, and associated headaches. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- High intensity laser and traditional physical therapy exercise program
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 21 May 2023to 10 Feb 2025
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with temporomandibular joint disorders (myofascial pain, trismus and limitation of ROM) after head and neck cancer, patients will be diagnosed by an experienced oral and maxillofacial surgeon.
- Patients with 20 to 60 years old.
- 6 months after ending radiotherapy.
Who cannot join
- Patients with implants.
- Current metastasis.
- Continuing radiotherapy.
- Pregnant females.
- Sensitivity to phototherapy.
- Bells palsy.
- Subjects with disk displacement, arthralgia or osteoarthritis at TMJ.
- Subjects who received analgesics or antidepressants.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of High Intensity Laser Therapy on Temporomandibular Joint Disorders After Head and Neck Cancer.
Temporomandibular disorder (TMD) is a term describing musculoskeletal conditions of the face, jaw and temporal regions. TMD is frequently associated with pain and/or dysfunction such as impaired jaw function, pain in the temporomandibular joint (TMJ), muscles and/or related structures, and associated headaches. The aetiology of TMD is multifactorial and complex.
Read the detailed description
It is known that one cause of TMD symptom development is treatment for head and neck cancer (HNC). The main treatment modalities for HNC include radiotherapy (RT) with or without chemotherapy and surgical intervention, either as a single therapy or a combination therapy. In the head and neck region, the anatomical structures are necessary for essential functions such as speech, swallowing, breathing, smell, and taste. The treatment of head and neck tumours may frequently impair some of these functions, which may result in pain, oral dysfunction, and impaired health-related quality of life.
High intensity laser therapy (HILT) is a non-invasive and painless treatment method. The latest studies have reported the beneficial effects of neodymium-doped yttrium aluminum garnet (Nd: YAG) laser therapy in patients with pain. The advantage of HILT over low level laser therapy (LLLT) is that HILT is able to penetrate and stimulate wider and/or deeper areas; thus, considerably more energy may be transmitted to tissue during HILT therapy compared to LLLT.
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- High intensity laser, traditional physical therapy exercise program, placebo High intensity laser
- Keywords
- High Intensity Laser Therapy, Temporomandibular Joint Disorders, Head And Neck Cancer
- Medical subject headings
- Temporomandibular Joint Disorders, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity laserDevice
patients will receive Nd: YAG with wavelength 1064 nm, peak power 3KW, energy density 360-1780 mJ/cm2, a short duration 120-150 micro sec, a mean power 10.5 W, a low frequency 10-40 HZ, a duty cycle of 0.1%, a probe diameter of 0.5 cm and spot size of 0.2 cm2. The treatment will be applied into 3 phases in each session. In addition to the traditional physical therapy exercise program (passive and active ROM exercises, stretching and strengthening exercises) for 20 minutes, total session time is 35 minutes, 3 days/ week for 4 weeks.
traditional physical therapy exercise programOther
passive and active ROM exercises, stretching and strengthening exercises for 35 minutes, 3 days/ week for 4 weeks.
placebo High intensity laserDevice
patients will receive placebo HILT including the same treatment as in group A but the laser device will be turned off.
| Study group | Role | What they receive |
|---|---|---|
| Group A (High Intensity Laser Therapy Group) | Experimental | patients will receive HILT in addition to traditional physical therapy exercise program Receives: Device: High intensity laser; Other: traditional physical therapy exercise program |
| Group B (Placebo-Control Group) | Placebo comparator | patients will receive placebo HILT in addition to traditional physical therapy exercise program Receives: Other: traditional physical therapy exercise program; Device: placebo High intensity laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
It will be measured by visual analogue scale. It starts with no pain at the left side and gradually increasing pain towards the end of the line at the right side (0-10) and high scores indicate greater pain.
Measured: 4 weeks
Secondary outcomes (4)
Range of motion
Range of motion of temporomandibular joint will be measured by Vernier caliper scale
Measured: 4 weeks
Muscle power assessment
Surface electromyography (EMG) will be used to evaluate the strength of the masseter and anterior temporal muscles
Measured: 4 weeks
Functional disability
It will be measured by jaw functional limitation scale-20. It has a score range of 1 to 200, and high scores indicate worsening jaw function.
Measured: 4 weeks
Quality of life (Oral health Impact Profile)
By using the Oral health Impact Profile consisted of 7 different domains (functional limitation, physical pain, psychological discomfort, psychological disability, physical disability, social disability, and handicap). Each domain was assessed by two questions, scored using a 5-point Likert scale (0 = never to 4 = very often). The total score was derived by a summing of the domain scores, it can range from 0 to 56. A higher score indicates a poorer quality of life.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start21 May 2023
- Primary completion1 Dec 2024
- Study completion10 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DisordersStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesma Morgan Allam, Cairo University
- Investigators
- Hadaya M Eladl, PhD, Study director, Assisstant professor of physical therapy for surgery, Faculty of physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868460
- Sponsor's protocol ID
- P.T.REC/012/004499
- Status last verified
- May 2023
- First submitted
- 10 May 2023
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study results
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of High Intensity Laser Therapy on Temporomandibular Joint Disorders After Head and Neck Cancer.
- ClinicalTrials.gov ID
- NCT05868460
- Acronym / sponsor ID
- P.T.REC/012/004499
- Conditions
- Temporomandibular Joint Disorders
- Keywords
- High Intensity Laser Therapy, Temporomandibular Joint Disorders, Head And Neck Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 21 May 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 10 Feb 2025 (actual)
- First posted
- 22 May 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.
Temporomandibular disorder (TMD) is a term describing musculoskeletal conditions of the face, jaw and temporal regions. TMD is frequently associated with pain and/or dysfunction such as impaired jaw function, pain in the temporomandibular joint (TMJ), muscles and/or related structures, and associated headaches. The aetiology of TMD is multifactorial and complex.
Detailed description
It is known that one cause of TMD symptom development is treatment for head and neck cancer (HNC). The main treatment modalities for HNC include radiotherapy (RT) with or without chemotherapy and surgical intervention, either as a single therapy or a combination therapy. In the head and neck region, the anatomical structures are necessary for essential functions such as speech, swallowing, breathing, smell, and taste. The treatment of head and neck tumours may frequently impair some of these functions, which may result in pain, oral dysfunction, and impaired health-related quality of life.
High intensity laser therapy (HILT) is a non-invasive and painless treatment method. The latest studies have reported the beneficial effects of neodymium-doped yttrium aluminum garnet (Nd: YAG) laser therapy in patients with pain. The advantage of HILT over low level laser therapy (LLLT) is that HILT is able to penetrate and stimulate wider and/or deeper areas; thus, considerably more energy may be transmitted to tissue during HILT therapy compared to LLLT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (High Intensity Laser Therapy Group) | Experimental | Device: High intensity laser, Other: traditional physical therapy exercise programpatients will receive HILT in addition to traditional physical therapy exercise program |
| Group B (Placebo-Control Group) | Placebo comparator | Other: traditional physical therapy exercise program, Device: placebo High intensity laserpatients will receive placebo HILT in addition to traditional physical therapy exercise program |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with temporomandibular joint disorders (myofascial pain, trismus and limitation of ROM) after head and neck cancer, patients will be diagnosed by an experienced oral and maxillofacial surgeon.
- Patients with 20 to 60 years old.
- 6 months after ending radiotherapy.
Key exclusion criteria (8 listed)
- Patients with implants.
- Current metastasis.
- Continuing radiotherapy.
- Pregnant females.
- Sensitivity to phototherapy.
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 intensity laserpatients will receive Nd: YAG with wavelength 1064 nm, peak power 3KW, energy density 360-1780 mJ/cm2, a short duration 120-150 micro sec, a mean power 10.5 W, a low frequency 10-40 HZ, a duty cycle of 0.1%, a probe diameter of 0.5 cm and spot size of 0.2 cm2. The treatment will be applied into 3 phases in each session. In addition to the traditional physical therapy exercise program (passive and active ROM exercises, stretching and strengthening exercises) for 20 minutes, total session time is 35 minutes, 3 days/ week for 4 weeks. | Device | Group A (High Intensity Laser Therapy Group) |
| traditional physical therapy exercise programpassive and active ROM exercises, stretching and strengthening exercises for 35 minutes, 3 days/ week for 4 weeks. | Other | Group A (High Intensity Laser Therapy Group), Group B (Placebo-Control Group) |
| placebo High intensity laserpatients will receive placebo HILT including the same treatment as in group A but the laser device will be turned off. | Device | Group B (Placebo-Control Group) |
Primary outcome
Pain intensity
Time frame: 4 weeks
It will be measured by visual analogue scale. It starts with no pain at the left side and gradually increasing pain towards the end of the line at the right side (0-10) and high scores indicate greater pain.
4 secondary outcomes
Range of motion
Time frame: 4 weeks
Muscle power assessment
Time frame: 4 weeks
Functional disability
Time frame: 4 weeks
Quality of life (Oral health Impact Profile)
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: Yes. Study results
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Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
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R01_Pilot Jaw Muscle Phenotypes
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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.
Hadaya M Eladl, PhD study director
Assisstant professor of physical therapy for surgery, Faculty of physical therapy
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 intensity laser and traditional physical therapy exercise program in people with Temporomandibular Joint Disorders, 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 14 Feb 2025. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Feb 2025.