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

• Sponsor: University of California, Los Angeles (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00992108
• Collaborator: (none)
• Enrollment: 17
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 1.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Face Pain	Drug: lidocaine; Drug: chemodenervation	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Efficacy of Botulinum Toxin Versus Lidocaine in Treating Masticatory Myofascial Face Pain Using Ultrasound and EMG Guided Techniques
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Oct 1, 2010
• Actual Study Completion Date: Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Lidocaine lidocaine injection group	Drug: lidocaine; 1cc 1%
Experimental: Botulinum	Drug: chemodenervation; botulinum toxin

Outcome Measures

Primary Outcome Measures

1. Clinical Response as Assessed by >20% Change From Baseline in the Jaw Functional Limitation Scale (JFLS) Global Score [4 months]

   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

1. Clinical Response as Assessed by >20% Change From Baseline in the Jaw Functional Limitation Scale (JFLS) Global Score [6 weeks]

   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."

2. Clinical Response as Assessed by >20% Change From Baseline in the Pressure Pain Threshold [baseline, 4 months]

   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).

3. Clinical Response as Assessed by >20% Change From Baseline in Jaw Opening [baseline, 4 months]

   maximum mandibular range of motion scores (measured as the maximum interincisal distance and compensating for occlusion)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Westwood Associates	Los Angeles	California	United States	90024

Sponsors and Collaborators

• University of California, Los Angeles

Investigators

• Principal Investigator: Marisa Chang, M.D., University of California, Los Angeles

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT00992108
• Other Study ID Numbers: 8295968
• First Posted: Oct 9, 2009
• Last Update Posted: Dec 29, 2016
• Last Verified: Nov 1, 2016

• Keywords provided by University of California, Los Angeles: Bruxism; Myofascial pain; EMG; Ultrasound; Masticatory myofascial face pain from bruxism and clenching
• Additional relevant MeSH terms: Facial Pain; Lidocaine

Study Results

Participant Flow

Arm/Group Title	Lidocaine	Botulinum
Arm/Group Description	lidocaine injection group lidocaine: 1cc 1%	chemodenervation: botulinum toxin
Period Title: Overall Study
STARTED	7	10
COMPLETED	7	9
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Lidocaine	Botulinum	Total
Arm/Group Description	lidocaine injection group lidocaine: 1cc 1%	chemodenervation: botulinum toxin	Total of all reporting groups
Overall Participants	7	10	17
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	57.14	44.7	49.82
Gender (Count of Participants)
Female	6 85.7%	8 80%	14 82.4%
Male	1 14.3%	2 20%	3 17.6%
Region of Enrollment (participants) [Number]
United States	7 100%	10 100%	17 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

participants who completed the 4-month follow-up

Arm/Group Title	Lidocaine	Botulinum
Arm/Group Description	lidocaine injection group lidocaine: 1cc 1%	chemodenervation: botulinum toxin
Measure Participants	7	9
Number [participants]	5 71.4%	7 70%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lidocaine	Botulinum
Arm/Group Description	lidocaine injection group lidocaine: 1cc 1%	chemodenervation: botulinum toxin
Measure Participants	7	10
Number [participants]	5 71.4%	6 60%

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Participants completing the 4-month follow-up

Arm/Group Title	Lidocaine	Botulinum
Arm/Group Description	lidocaine injection group lidocaine: 1cc 1%	chemodenervation: botulinum toxin
Measure Participants	7	9
Number [participants]	3 42.9%	4 40%

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Participants completing the 4-month follow-up

Arm/Group Title	Lidocaine	Botulinum
Arm/Group Description	lidocaine injection group lidocaine: 1cc 1%	chemodenervation: botulinum toxin
Measure Participants	7	9
Number [participants]	2 28.6%	0 0%

Adverse Events

Time Frame	4 months
Arm/Group Title	Lidocaine		Botulinum
Arm/Group Description	lidocaine injection group lidocaine: 1cc 1%		chemodenervation: botulinum toxin
All Cause Mortality
	Lidocaine		Botulinum
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Lidocaine		Botulinum
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Lidocaine		Botulinum
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/7 (14.3%)		2/10 (20%)
General disorders
Headache	1/7 (14.3%)	1	1/10 (10%)	1
Musculoskeletal and connective tissue disorders
facial muscle weakness	0/7 (0%)	0	1/10 (10%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.