TMDPhase 1NCT01659372
Low Level Laser Therapy Versus Pharmacotherapy in in Improving Masticatory Muscle Pain
A Phase 1 study testing low level laser therapy and Naproxen in people with TMD, run by Shahid Beheshti University at 2 sites in Iran.
Trial summary
tempromandibuar disorders are a group of heterogenous pathologies affecting temporomandibular joint,muscles or both.in more than 90%of cases muscles are the origin of pain.TMDs cause pain,movement disability and deficit in quality of life.in more than 90%of cases pain is the major complaint.we run this investigation… Read more about this study
- Who is it for?
- Ages 15 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- TMD
- What is being tested?
- low level laser therapy and Naproxen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesIran
- Study dates
- Jun 2012to Mar 2013
- Phase
- Phase 1
- 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 15 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- patients with TMD affecting masticatory muscles
Who cannot join
- systemic disease
- GI problem
- pregnancy
- epidermal cancer
Trial locations and contacts
2 sites in 1 country.
Iran2 sites, 2 recruiting
- Not yet recruiting
Shahid Beheshti University
Tehran, 1983969411
- Recruiting
Shahid Beheshti University
Tehran, 1983969411
saranaz azari-marhabi, doctor, 00989190129151, saranazazari@yahoo.com
saranaz azari-marhabi, resident
About this study
Official title: Phase 1 Study of Low Level Laser Therapy Versus Naproxen
tempromandibuar disorders are a group of heterogenous pathologies affecting temporomandibular joint,muscles or both.in more than 90%of cases muscles are the origin of pain.TMDs cause pain,movement disability and deficit in quality of life.in more than 90%of cases pain is the major complaint.we run this investigation to find the analgesic effct of low level laser therapy versus pharmacotherapy with naproxen in improving pain.
- Conditions
- TMD
- Being tested
- low level laser therapy, Naproxen
- Keywords
- temporomandibular disorder, myofascial pain syndrome
- Medical subject headings
- Temporomandibular Joint Disorders, Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low level laser therapyRadiation
NaproxenDrug
| Study group | Role | What they receive |
|---|---|---|
| Low level laser therapy | Experimental | this arm recieves low level laser therapy treatment for 12 sessions. Receives: Radiation: low level laser therapy |
| naproxen | Experimental | this arm takes naproxen 500 mg twice daily for 3weeks Receives: Drug: Naproxen |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction of paim measured by VAS
VAS is visual analogue scale
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2012 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMDStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, saranaz azari-marhabi, Shahid Beheshti University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01659372
- Sponsor's protocol ID
- ABT-1233-RV
- Status last verified
- Aug 2012
- First submitted
- 4 Aug 2012
- Last updated
- 7 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Low Level Laser Therapy Versus Naproxen
- ClinicalTrials.gov ID
- NCT01659372
- Acronym / sponsor ID
- ABT-1233-RV
- Conditions
- TMD
- Keywords
- temporomandibular disorder, myofascial pain syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shahid Beheshti UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 7 Aug 2012 (estimated)
- 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.
tempromandibuar disorders are a group of heterogenous pathologies affecting temporomandibular joint,muscles or both.in more than 90%of cases muscles are the origin of pain.TMDs cause pain,movement disability and deficit in quality of life.in more than 90%of cases pain is the major complaint.we run this investigation to find the analgesic effct of low level laser therapy versus pharmacotherapy with naproxen in improving pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low level laser therapy | Experimental | Radiation: low level laser therapythis arm recieves low level laser therapy treatment for 12 sessions. |
| naproxen | Experimental | Drug: Naproxenthis arm takes naproxen 500 mg twice daily for 3weeks |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with TMD affecting masticatory muscles
Key exclusion criteria (4 listed)
- systemic disease
- GI problem
- pregnancy
- epidermal cancer
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 |
|---|---|---|
| low level laser therapy | Radiation | Low level laser therapy |
| Naproxen | Drug | naproxen |
Primary outcome
reduction of paim measured by VAS
Time frame: 1 month
VAS is visual analogue scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2012.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing low level laser therapy and Naproxen in people with TMD, run by Shahid Beheshti University at 2 sites in Iran.
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 1 inclusion and 4 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 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iran. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 saranaz azari marhabi, post graduate student (00989190129151, saranazazari@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction of paim measured by VAS (time frame: 1 month). 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 7 Aug 2012.