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

October 18, 2015 updated by: Doron Aframian
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Temporomandibular disorder is one of the main reasons for the pain and damage to the function in the head, jaws and neck (1,2) term is somewhat misleading because it includes two types of pain, one originates from the temporomandibular joint , and another originates mainly from the muscles of mastication - Myofacial pain (MFP). The last is the one we seek to explore the etiology of this pain is explained using a biological-psychological model, which reflects the complex interaction between physical factors, behavioral, social and emotional influences (3). The pain may last from weeks to many months; it is usually more severe on one side of the face, especially at pre-auricular area (front ear). Intensity of the pain is usually moderate; it has a squeezing, dull nature. It worsens during mouth opening and often causes opening restriction (5, 4). One can find trigger points where the pain is harsh and radiates to remote areas. Treatment is often integrated, multi-systemic and comprehensive (7, 6): physical therapy, behavioral therapy, night splints, Trigger point injection, and the use of drugs from different families are used to manage and treat MVP. Among the drugs that we use routinely are: Amitriptyline and nortriptyline from the family of tricyclic antidepressants (TAC's). These drugs were originally intended to treat depression and now days there primary use is to treat chronic pain from muscle origin, the use is in low doses of 10-35 mg /d, with no connection to the anti-depressive effect (8,9,10,11). . Gabapentin is gaba-amino buyic acid (GABA) analogue originally developed as an anti-epileptic (12). This drug is also used as a first treatment in neuropathic pain (13). A study published in 2007 by Kimos et al (14) suggested that using gabapentin at higher doses up to 4200 mg per day is a therapeutic option for myofacial pain. The authors prospectively examined the use of gabapentin versus placebo in myofacial pain over 12 weeks in 50 patients, of whom 36 completed the study, the results demonstrated improvement in any parameter. Another study conducted in our department and accepted for publication in journal of orafacail pain & headache examined retrospectively gabapentin Vs amitriptyline with better results for gabapentin in more complex and widely spread disorder. To gabapentin side effect drug interactions profile better than amitriptyline (16). Moreover, gabapentin has no anticholinergic which usually limits the use of amitriptyline. Therefore, gabapentin may be an attractive alternative for the treatment of MFP. Our clinic use gabapentin routinely as second option after lack of response to amitriptyline. The aim of this study is to compare prospectively the efficacy amitriptyline in low doses up to 20 mg to gabapentin at low doses up to 900mg.

Patients over the age of 18 that will come to orofacial pain clinic in the department of Oral medicine, and which will be diagnosed as suffering from facial pain originating from chewing muscles (MVP) for at least three months, will be invited to participate in the study. The examination is the one we use routinely and includes: patient demographics: age, sex, marital status, occupation, and medical history. Pain characteristics includes : Location, duration, intensity (subjective), the nature of the pain, whether pain is prolonged or not, frequency and duration of attacks, disruption of sleep, quality of life and everyday functioning (work, company), whether the pain is accompanied by autonomic of systemic signs and whether the patient suffers from pain in the body outside the region head and neck. Patient will receive a questionnaire examining the accompanying emotional distress (AXIS II). Masticatory muscle involvement will be examined by palpation, load testing, restriction or non-limitation of mouth opening. All of which are routinely use in our department.

Patients will receive an explanation of the nature of the disease and possible treatments. Patients that would like to participate in the study, will sign a consent form, receive a pain questionnaire and start medication treatment which is acceptable in cases of myofacial pain. The drugs that will be used are: amitriptyline up to 20 mg and Gabapentin up to 900 mg. Patients with any side effects will call to receive instructions. After one month, patients will be invited to our clinic. A clinical examination, similar to one mention above will be performed with re-filling of the questionnaires. First medication treatment will discontinue and after two weeks will be replaced with the equivalent drug. Meaning patients that will begin with amitriptyline will continue with gabapentin (after two weeks break) and vice versa (cross over design). After another month patients will be invited to the clinic for further similar clinical examination and questionnaires fulfilling, then, if necessary patients will continue their preferred treatment. . All patients will give their consent to participate in the study.

Criteria for improvement include: 1. Intensity of pain according to VAS scale. 2. The frequency of the attacks. 3. The frequency of use of other drugs (for the treatment of chronic or acute pain). 4. Improving function - open mouth, free jaw movement. 5. Quality Health Index (AXIS II).

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • alterolet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain decrease
Time Frame: 6 weeks
pain scale measuring
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The frequency of use of other drugs
Time Frame: 6 weeks
breacking drugs registration
6 weeks
Improving function - open mouth, free jaw movement
Time Frame: 6 weeks
opening mouth measurement
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Doron Aframian

Investigators

  • Principal Investigator: Doron J Aframian, DMD,PhD, Hadassah Medical Organization

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

December 14, 2014

First Submitted That Met QC Criteria

January 12, 2015

First Posted (Estimate)

January 15, 2015

Study Record Updates

Last Update Posted (Estimate)

October 20, 2015

Last Update Submitted That Met QC Criteria

October 18, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • gbvsam001-HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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