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NCT00992108 · ClinicalTrials.gov registry record · Phase 4
Efficacy of Botulinum Toxin Versus Lidocaine in Treating Masticatory Myofascial Face Pain Using Ultrasound and EMG Guided Techniques
A Phase 4 study, sponsored by University of California, Los Angeles.
- Terminated
- Registry status
- Phase 4
- Development phase
- 17
- Enrollment target
NCT00992108 is a Phase 4 study that was terminated before completion, run by University of California, Los Angeles. The registered enrollment target is 17 participants.
The verdict
NCT00992108, a Phase 4 study, was terminated before completion, sponsored by University of California, Los Angeles.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 17 participants
- Enrollment target
Study 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 b
Interventions
- DRUG lidocaine
- DRUG chemodenervation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2009-10 |
| Est. Completion | 2010-10 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00992108
The ClinicalTrials.gov registry entry for NCT00992108 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which lidocaine is the first listed.
NCT00992108 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00992108 about?
NCT00992108 is a clinical study titled "Efficacy of Botulinum Toxin Versus Lidocaine in Treating Masticatory Myofascial Face Pain Using Ultrasound and EMG Guided Techniques". 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 ra...
What is the current status of trial NCT00992108?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 17 participants. The study started on 2009-10. Estimated completion is 2010-10.
What interventions are being tested in trial NCT00992108?
The interventions under investigation include: lidocaine (DRUG), chemodenervation (DRUG).
Who is sponsoring clinical trial NCT00992108?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
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