Botulinum Toxin Versus Placebo Injections to Temporalis and Masseter Muscles

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byGwendolyn S Reeve, DMD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Weill Medical College of Cornell University

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study aims to determine whether the injection of botulinum toxin A or placebo (unpreserved 0.9% sodium chloride) into the masseter and temporalis muscles provides pain relief and improved jaw function in those who suffer from myofascial pain disorder. The study hypothesis is that botulinum toxin A injection is superior to placebo. The specific research questions are: 1. Is the injection of botulinum toxin A superior to placebo for the improvement in pain? 2. Is the injection of botulinum toxin A superior to placebo for the improvement in function or quality of life (QOL)? 3. Are there any adverse effects that result from injection of botulinum toxin A or placebo into the masseters and temporalis muscles? Limited data exists to support the use of botulinum toxin A in the management of myofascial pain disorder of the masticatory region. Botulinum toxin A is not FDA approved for intra-muscular injection within the masticatory region. Its use in the masticatory region is considered off-label but performed without significant known complications. This study will provide the opportunity to quantitate and qualitate any complications in a large prospective sample of patients.

Eligibility Criteria

Inclusion Criteria

You have the ability to give informed consent.

Pain in one or more of the masticatory muscles.

You have a baseline pain of 3.5/10 or more on a visual analog scale.

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Treatment Details

Interventions

0.9% Sodium Chloride Injection (Procedure)
Botulinum toxin type A (Neurotoxin)

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Botulinum Toxin Type AExperimental Treatment1 Intervention

The intramuscular injections will be performed with the patient awake in the oral and maxillofacial surgery clinic. Three injection sites into bilateral masseter muscles and two injection sites into bilateral temporalis muscles will be identified by having the patient clench. The sites will be marked with a surgical pen prior to injections. The skin at the injection sites will be cleaned with an alcohol swab. Via a 1cc TB syringe and a 30-gauge needle, the subject will then receive 100 units of reconstituted botulinum toxin A. 37.5 units will be injected into each masseter muscle and 12.5 units into each temporalis muscle. A written post-operative instruction sheet will be provided to all patients.

Group II: 0.9% Sodium Chloride InjectionPlacebo Group1 Intervention

The intramuscular injections will be performed with the patient awake in the oral and maxillofacial surgery clinic. Three injection sites into bilateral masseter muscles and two injection sites into bilateral temporalis muscles will be identified by having the patient clench. The sites will be marked with a surgical pen prior to injections. The skin at the injection sites will be cleaned with an alcohol swab. Via a 1cc TB syringe and a 30-gauge needle, the subject will then receive unpreserved 0.9% sodium chloride. A written post-operative instruction sheet will be provided to all patients.

Botulinum toxin type A is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Xeomin for: