Efficacy of Botulinum Toxin Versus Lidocaine in Treating Masticatory Myofascial Face Pain Using Ultrasound and EMG Guided Techniques
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| ClinicalTrials.gov Identifier: NCT00992108 |
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Recruitment Status :
Terminated
(Lack of eligible patients willing and able to participate)
First Posted : October 9, 2009
Results First Posted : December 29, 2016
Last Update Posted : December 29, 2016
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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 Type : | Interventional (Clinical Trial) |
| 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 : | October 2009 |
| Actual Primary Completion Date : | October 2010 |
| Actual Study Completion Date : | October 2010 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Lidocaine
lidocaine injection group
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Drug: lidocaine
1cc 1% |
| Experimental: Botulinum |
Drug: chemodenervation
botulinum toxin |
- Clinical Response as Assessed by >20% Change From Baseline in the Jaw Functional Limitation Scale (JFLS) Global Score [ Time Frame: 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."
- Clinical Response as Assessed by >20% Change From Baseline in the Jaw Functional Limitation Scale (JFLS) Global Score [ Time Frame: 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."
- Clinical Response as Assessed by >20% Change From Baseline in the Pressure Pain Threshold [ Time Frame: 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).
- Clinical Response as Assessed by >20% Change From Baseline in Jaw Opening [ Time Frame: baseline, 4 months ]maximum mandibular range of motion scores (measured as the maximum interincisal distance and compensating for occlusion)
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00992108
| United States, California | |
| Westwood Associates | |
| Los Angeles, California, United States, 90024 | |
| Principal Investigator: | Marisa Chang, M.D. | University of California, Los Angeles |
| Responsible Party: | University of California, Los Angeles |
| ClinicalTrials.gov Identifier: | NCT00992108 History of Changes |
| Other Study ID Numbers: |
8295968 |
| First Posted: | October 9, 2009 Key Record Dates |
| Results First Posted: | December 29, 2016 |
| Last Update Posted: | December 29, 2016 |
| Last Verified: | November 2016 |
Keywords provided by University of California, Los Angeles:
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Bruxism Myofascial pain EMG Ultrasound Masticatory myofascial face pain from bruxism and clenching |
Additional relevant MeSH terms:
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Facial Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Lidocaine Botulinum Toxins Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs |
Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Acetylcholine Release Inhibitors Cholinergic Agents Neurotransmitter Agents |