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

This study is currently recruiting participants.
Verified August 2012 by Shahid Beheshti University
Sponsor:
Information provided by (Responsible Party):
saranaz azari-marhabi, Shahid Beheshti University
ClinicalTrials.gov Identifier:
NCT01659372
First received: August 4, 2012
Last updated: August 6, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention Phase
TMD
 Radiation: low level laser therapy
Drug: Naproxen
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase 1 Study of Low Level Laser Therapy Versus Naproxen

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shahid Beheshti University:

Primary Outcome Measures:
  • reduction of paim measured by VAS [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    VAS is visual analogue scale


Estimated Enrollment: 40
Study Start Date: June 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: August 4, 2012
Last Updated: August 6, 2012
Health Authority: Iran: Ministry of Health

Keywords provided by 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
Pharmacologic Actions
 Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013