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Low Level Laser Therapy Versus Pharmacotherapy in in Improving Masticatory Muscle Pain

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ClinicalTrials.gov Identifier: NCT01659372
Recruitment Status : Unknown
Verified August 2012 by saranaz azari-marhabi, Shahid Beheshti University.
Recruitment status was:  Recruiting
First Posted : August 7, 2012
Last Update Posted : August 7, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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 to find the analgesic effct of low level laser therapy versus pharmacotherapy with naproxen in improving pain.

Condition or disease Intervention/treatment Phase
TMD Radiation: low level laser therapy Drug: Naproxen Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase 1 Study of Low Level Laser Therapy Versus Naproxen
Study Start Date : June 2012
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Low level laser therapy
this arm recieves low level laser therapy treatment for 12 sessions.
Radiation: low level laser therapy
Experimental: naproxen
this arm takes naproxen 500 mg twice daily for 3weeks
Drug: Naproxen


Outcome Measures

Primary Outcome Measures :
  1. reduction of paim measured by VAS [ Time Frame: 1 month ]
    VAS is visual analogue scale


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients with TMD affecting masticatory muscles

Exclusion Criteria:

  • systemic disease
  • GI problem
  • pregnancy
  • epidermal cancer
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01659372


Contacts
Contact: saranaz azari marhabi, post graduate student 00989190129151 saranazazari@yahoo.com

Locations
Iran, Islamic Republic of
Shahid Beheshti University Not yet recruiting
Tehran, Iran, Islamic Republic of, 1983969411
Shahid Beheshti University Recruiting
Tehran, Iran, Islamic Republic of, 1983969411
Contact: saranaz azari-marhabi, doctor    00989190129151    saranazazari@yahoo.com   
Principal Investigator: saranaz azari-marhabi, resident         
Sponsors and Collaborators
Shahid Beheshti University
More Information

Responsible Party: saranaz azari-marhabi, oral medicine resident, Shahid Beheshti University
ClinicalTrials.gov Identifier: NCT01659372     History of Changes
Other Study ID Numbers: ABT-1233-RV
First Posted: August 7, 2012    Key Record Dates
Last Update Posted: August 7, 2012
Last Verified: August 2012

Keywords provided by saranaz azari-marhabi, Shahid Beheshti University:
temporomandibular disorder
myofascial pain syndrome

Additional relevant MeSH terms:
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action