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

Primary Purpose

Face Pain

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
lidocaine
chemodenervation
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Face Pain focused on measuring Bruxism, Myofascial pain, EMG, Ultrasound, Masticatory myofascial face pain from bruxism and clenching

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Westwood Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Lidocaine

Botulinum

Arm Description

lidocaine injection group

Outcomes

Primary Outcome Measures

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."

Secondary Outcome Measures

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."
Clinical Response as Assessed by >20% Change From Baseline in the Pressure Pain Threshold
measurements were obtained by placing examiner's index finger of the examiner on the area of the trigger point (hyperirritable areas on skeletal muscle with palpable taut bands of muscle fibers) and exerting pressure until there was whitening of the nail bed. Pressure pain levels were rated subjectively by the participant and coded numerically as mild (1), moderate (2) to severe (3).
Clinical Response as Assessed by >20% Change From Baseline in Jaw Opening
maximum mandibular range of motion scores (measured as the maximum interincisal distance and compensating for occlusion)

Full Information

First Posted
October 8, 2009
Last Updated
November 2, 2016
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT00992108
Brief Title
Efficacy of Botulinum Toxin Versus Lidocaine in Treating Masticatory Myofascial Face Pain Using Ultrasound and EMG Guided Techniques
Official Title
Efficacy of Botulinum Toxin Versus Lidocaine in Treating Masticatory Myofascial Face Pain Using Ultrasound and EMG Guided Techniques
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Terminated
Why Stopped
Lack of eligible patients willing and able to participate
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Face Pain
Keywords
Bruxism, Myofascial pain, EMG, Ultrasound, Masticatory myofascial face pain from bruxism and clenching

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine
Arm Type
Active Comparator
Arm Description
lidocaine injection group
Arm Title
Botulinum
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
lidocaine
Intervention Description
1cc 1%
Intervention Type
Drug
Intervention Name(s)
chemodenervation
Intervention Description
botulinum toxin
Primary Outcome Measure Information:
Title
Clinical Response as Assessed by >20% Change From Baseline in the Jaw Functional Limitation Scale (JFLS) Global Score
Description
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."
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Clinical Response as Assessed by >20% Change From Baseline in the Jaw Functional Limitation Scale (JFLS) Global Score
Description
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."
Time Frame
6 weeks
Title
Clinical Response as Assessed by >20% Change From Baseline in the Pressure Pain Threshold
Description
measurements were obtained by placing examiner's index finger of the examiner on the area of the trigger point (hyperirritable areas on skeletal muscle with palpable taut bands of muscle fibers) and exerting pressure until there was whitening of the nail bed. Pressure pain levels were rated subjectively by the participant and coded numerically as mild (1), moderate (2) to severe (3).
Time Frame
baseline, 4 months
Title
Clinical Response as Assessed by >20% Change From Baseline in Jaw Opening
Description
maximum mandibular range of motion scores (measured as the maximum interincisal distance and compensating for occlusion)
Time Frame
baseline, 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marisa Chang, M.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Westwood Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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