Working… Menu

Prospective, Cross Over Gabapentin vs Amitriptyline Study on Patients Suffering From Masticatory Muscle Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02339662
Recruitment Status : Unknown
Verified October 2015 by Doron Aframian, Hadassah Medical Organization.
Recruitment status was:  Recruiting
First Posted : January 15, 2015
Last Update Posted : October 20, 2015
Information provided by (Responsible Party):
Doron Aframian, Hadassah Medical Organization

Brief Summary:
The purpose of the study is comparing two drugs efficacy for the treatment of pain originates from masticatory muscles. The two drugs are - Amitriptlyne (amitriptyline) and Gabapentin (gabapentin), both of them are common use in for the treatment of chronic pain Methods - patient that is diagnosed as suffering from myofacial pain, will receive one of the medications above (Gabapentin or amitriptyline) for one month only, after which he will be invited to pain clinic for control. Two weeks after that, the patient will start taking the other drug for 1 month and then invited again to the department for recall and continue standard treatment . The patient can choose whether to continue medication with one of the drugs or stop this medication treatment. Total duration of the experiment is two and a half months.

Condition or disease Intervention/treatment Phase
Myofacial Pain Drug: Gabapentin Drug: Amitriptyline Phase 4

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Cross Over Gabapentin vs Amitriptyline Study on Patients Suffering From Masticatory Muscle Pain
Study Start Date : February 2015
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : January 2017

Arm Intervention/treatment
Active Comparator: gabapentin
900 mg per day total, 3 pills of 300mg.
Drug: Gabapentin
muscles pain treatment

Active Comparator: amitriptyline
20 mg total, 1pill
Drug: Amitriptyline
muscles pain treatment
Other Name: alterolet

Primary Outcome Measures :
  1. pain decrease [ Time Frame: 6 weeks ]
    pain scale measuring

Secondary Outcome Measures :
  1. The frequency of use of other drugs [ Time Frame: 6 weeks ]
    breacking drugs registration

  2. Improving function - open mouth, free jaw movement [ Time Frame: 6 weeks ]
    opening mouth measurement

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients who suffer from chronic pain more than 3 months prior to arrival
  • patients who are capable to reach all the visits in the clinic
  • Not pregnant women

Exclusion Criteria:

  • Patients with other types of non-muscle origin pain
  • Patients without a clear diagnosis.
  • Patients who are not originally designated to medication treatment (regardless experiment) for various reasons eg pregnancy.
  • Patients who are not interested in medication.
  • Patients who are not interested or unable to cooperate.
  • Patients who suffer from chronic pain less than 3 months prior to arrival
  • Pregnant women

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 identifier (NCT number): NCT02339662

Layout table for location contacts
Contact: Doron J Aframian, DMD, PhD 972-2-677-6140
Contact: Yaron Haviv, DMD, PhD 972-2-6776140

Layout table for location information
Hadassah MO Recruiting
Jerusalem, Israel
Contact: Doron J Aframian, MD,PhD    97226776140   
Sponsors and Collaborators
Doron Aframian
Layout table for investigator information
Principal Investigator: Doron J Aframian, DMD,PhD Hadassah Medical Organization

Layout table for additonal information
Responsible Party: Doron Aframian, Professor in Oral Medicine, Hadassah Medical Organization Identifier: NCT02339662    
Other Study ID Numbers: gbvsam001-HMO-CTIL
First Posted: January 15, 2015    Key Record Dates
Last Update Posted: October 20, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Facial Pain
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Musculoskeletal Pain
Neurologic Manifestations
Amitriptyline, perphenazine drug combination
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Antidepressive Agents, Tricyclic
Antidepressive Agents
Analgesics, Non-Narcotic
Adrenergic Uptake Inhibitors