Efficacy of Botulinum Toxin Versus Lidocaine in Treating Masticatory Myofascial Face Pain Using Ultrasound and EMG Guided Techniques

NCT00992108 | Terminated Phase 4 Results DMC

• 1 other identifier: 8295968
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

Botulinum toxin-A (BTX-A) prevents the release of acetylcholine in presynaptic terminals of the neuromuscular junction. It has been proposed to be effective in spastic conditions of the head and neck including oromandibular dystonias, bruxism, and muscular hypertrophy (1,2,3,4). However, only one randomized, double-blinded, placebo controlled trial has been completed involving 20 patients demonstrating both objective and subjective improvement in the BTX-A treated group over those treated with saline at one week, one month, and six months (5). Currently, in most orofacial pain practices, when the diagnosis of masticatory myofascial pain in the head region is made, patients are treated with a standard myofascial protocol. This protocol involves stretching, application of moist heat, spray and stretch, and lidocaine trigger point injections into the masticatory muscles. This is considered the standard of care among most orofacial pain practioners. There have been no randomized, double-blinded, head-to-head trials comparing BTX-A injections to lidocaine injections in the treatment of masticatory myofacial pain. Moreover, in all studies, muscles were targeted using surface landmarks with no confirmatory tests to guarantee the medication was administered to the intended muscle. In previous studies, the medial and lateral pterygoid muscles, important masticatory muscles that is often hyperactive in masticatory myofacial pain was not injected due to lack of palpable surface landmarks. Ultrasound and electromyography (EMG) guidance will help us locate these muscles. The purpose of this study is to objectively measure functional improvement in patients with masticatory myofascial pain injected with lidocaine versus BTX-A. A pilot study enrolling 20 patients is proposed. 20 patients will be randomized to receive either BTX-A or lidocaine injections into the bilateral temporalis, masseter, and medial and lateral pterygoid. Objective and subjective clinical parameters will be measured. These include pain at rest and with chewing, maximum non-assisted and assisted mouth opening, protrusive and laterotrusive jaw movements, subjective efficacy of treatment, and side-effects of treatment. Patients will be assessed at baseline, one week, one month, and three months after the procedure.

Conditions

Face Pain

Keywords

Bruxism; Myofascial pain; EMG; Ultrasound; Masticatory myofascial face pain from bruxism and clenching

Outcome Measures

Primary Outcomes (1)

• Clinical Response as Assessed by >20% Change From Baseline in the Jaw Functional Limitation Scale (JFLS) Global Score

  The JFLS contains 20 items that measure limitations across mastication, vertical jaw mobility, and verbal/emotional expression rated on a 0-10 scale where 0 = "no limitation" and 10 = "severe limitation."

  4 months

Secondary Outcomes (3)

• Clinical Response as Assessed by >20% Change From Baseline in the Jaw Functional Limitation Scale (JFLS) Global Score

  6 weeks

• Clinical Response as Assessed by >20% Change From Baseline in the Pressure Pain Threshold

  baseline, 4 months

• Clinical Response as Assessed by >20% Change From Baseline in Jaw Opening

  baseline, 4 months

Study Arms (2)

Lidocaine

ACTIVE COMPARATOR

lidocaine injection group

Drug: lidocaine

Botulinum

EXPERIMENTAL

Drug: chemodenervation

Interventions

lidocaine DRUG

1cc 1%

Lidocaine

chemodenervation DRUG

botulinum toxin

Botulinum

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects are to have identifiable painful myofascial trigger points in the masseter, temporalis, and medial and lateral pterygoid muscles.
• Subjects will be examined by the principle investigators to determine if the individual is a suitable candidate for the study, based on active trigger points and willingness to participate in the study

You may not qualify if:

• Pregnant woman will be excluded from participation as potential risk is noted in product label indications. Individuals over the age of 65 will be excluded per product label indications that reflect lack of data in individuals over age 65.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

Westwood Associates

Los Angeles, California, 90024, United States

Location

MeSH Terms

Conditions

Facial Pain; Bruxism

Interventions

Lidocaine; Nerve Block

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Tooth Diseases; Stomatognathic Diseases; Habits; Behavior

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Marisa Chang, MD
• Organization: UCLA Neurology

marisachang@mednet.ucla.edu

310-794-1870

Study Officials

• Marisa Chang, M.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2009
• First Posted: October 9, 2009
• Study Start: October 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: December 29, 2016
• Results First Posted: December 29, 2016

Record last verified: 2016-11

Locations

US (1)