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

NCT02339662 | Unknown Phase 4

• 1 other identifier: gbvsam001-HMO-CTIL
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Myofacial Pain

Outcome Measures

Primary Outcomes (1)

• pain decrease

  pain scale measuring

  6 weeks

Secondary Outcomes (2)

• The frequency of use of other drugs

  6 weeks

• Improving function - open mouth, free jaw movement

  6 weeks

Study Arms (2)

gabapentin

ACTIVE COMPARATOR

900 mg per day total, 3 pills of 300mg.

Drug: Gabapentin

amitriptyline

ACTIVE COMPARATOR

20 mg total, 1pill

Drug: Amitriptyline

Interventions

Gabapentin DRUG

muscles pain treatment

gabapentin

Amitriptyline DRUG

muscles pain treatment

Also known as: alterolet

amitriptyline

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Doron Aframian: lead

Study Sites (1)

Hadassah MO

Jerusalem, Israel

RECRUITING

Related Publications (13)

• Tjakkes GH, Reinders JJ, Tenvergert EM, Stegenga B. TMD pain: the effect on health related quality of life and the influence of pain duration. Health Qual Life Outcomes. 2010 May 2;8:46. doi: 10.1186/1477-7525-8-46.

  PMID: 20433769 BACKGROUND

• Maixner W, Diatchenko L, Dubner R, Fillingim RB, Greenspan JD, Knott C, Ohrbach R, Weir B, Slade GD. Orofacial pain prospective evaluation and risk assessment study--the OPPERA study. J Pain. 2011 Nov;12(11 Suppl):T4-11.e1-2. doi: 10.1016/j.jpain.2011.08.002. No abstract available.

  PMID: 22074751 BACKGROUND

• Benoliel R, Svensson P, Heir GM, Sirois D, Zakrzewska J, Oke-Nwosu J, Torres SR, Greenberg MS, Klasser GD, Katz J, Eliav E. Persistent orofacial muscle pain. Oral Dis. 2011 Apr;17 Suppl 1:23-41. doi: 10.1111/j.1601-0825.2011.01790.x.

  PMID: 21382137 BACKGROUND

• Kino K, Sugisaki M, Haketa T, Amemori Y, Ishikawa T, Shibuya T, Sato F, Amagasa T, Shibuya T, Tanabe H, Yoda T, Sakamoto I, Omura K, Miyaoka H. The comparison between pains, difficulties in function, and associating factors of patients in subtypes of temporomandibular disorders. J Oral Rehabil. 2005 May;32(5):315-25. doi: 10.1111/j.1365-2842.2004.01439.x.

  PMID: 15842238 BACKGROUND

• Benoliel R, Eliav E, Sharav Y. Classification of chronic orofacial pain: applicability of chronic headache criteria. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Dec;110(6):729-37. doi: 10.1016/j.tripleo.2010.07.009.

  PMID: 21112531 BACKGROUND

• Sherman JJ, Turk DC. Nonpharmacologic approaches to the management of myofascial temporomandibular disorders. Curr Pain Headache Rep. 2001 Oct;5(5):421-31. doi: 10.1007/s11916-001-0053-7.

  PMID: 11560807 BACKGROUND

• Diamond S, Baltes BJ. Chronic tension headache--treated with amitriptyline--a double-blind study. Headache. 1971 Oct;11(3):110-6. doi: 10.1111/j.1526-4610.1971.hed1103110.x. No abstract available.

  PMID: 4940167 BACKGROUND

• Pilowsky I, Hallett EC, Bassett DL, Thomas PG, Penhall RK. A controlled study of amitriptyline in the treatment of chronic pain. Pain. 1982 Oct;14(2):169-179. doi: 10.1016/0304-3959(82)90097-5.

  PMID: 6757842 BACKGROUND

• Plesh O, Curtis D, Levine J, McCall WD Jr. Amitriptyline treatment of chronic pain in patients with temporomandibular disorders. J Oral Rehabil. 2000 Oct;27(10):834-41. doi: 10.1046/j.1365-2842.2000.00572.x.

  PMID: 11065017 BACKGROUND

• Johannessen SI, Ben-Menachem E. Management of focal-onset seizures: an update on drug treatment. Drugs. 2006;66(13):1701-25. doi: 10.2165/00003495-200666130-00004.

  PMID: 16978035 BACKGROUND

• Haviv Y, Zadik Y, Sharav Y, Benoliel R. Painful traumatic trigeminal neuropathy: an open study on the pharmacotherapeutic response to stepped treatment. J Oral Facial Pain Headache. 2014 Winter;28(1):52-60. doi: 10.11607/jop.1154.

  PMID: 24482788 BACKGROUND

• Kimos P, Biggs C, Mah J, Heo G, Rashiq S, Thie NM, Major PW. Analgesic action of gabapentin on chronic pain in the masticatory muscles: a randomized controlled trial. Pain. 2007 Jan;127(1-2):151-60. doi: 10.1016/j.pain.2006.08.028. Epub 2006 Oct 9.

  PMID: 17030096 BACKGROUND

• Chandra K, Shafiq N, Pandhi P, Gupta S, Malhotra S. Gabapentin versus nortriptyline in post-herpetic neuralgia patients: a randomized, double-blind clinical trial--the GONIP Trial. Int J Clin Pharmacol Ther. 2006 Aug;44(8):358-63. doi: 10.5414/cpp44358.

  PMID: 16961166 BACKGROUND

MeSH Terms

Conditions

Facial Pain

Interventions

Gabapentin; Amitriptyline

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds

Study Officials

• Doron J Aframian, DMD,PhD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Doron J Aframian, DMD, PhD

CONTACT

972-2-677-6140; Dorona@hadassah.org.il

Yaron Haviv, DMD, PhD

CONTACT

972-2-6776140; yaron.haviv@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor in Oral Medicine

Study Record Dates

• First Submitted: December 14, 2014
• First Posted: January 15, 2015
• Study Start: February 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2017
• Last Updated: October 20, 2015

Record last verified: 2015-10

Locations

IL (1)