Botulinum Toxin Versus Placebo Injections to Temporalis and Masseter Muscles

Launched by WEILL MEDICAL COLLEGE OF CORNELL UNIVERSITY · Jul 18, 2017

Keywords

ClinConnect Summary

Myofascial pain is classically used to describe pain experienced in the masticatory muscles and its associated structures (Freund 1999). It afflicts nearly 10% of Americans (Freund 2000). There have been many described treatments such as the use of oral appliances, non-steroidal anti-inflammatory medications, physiotherapy, behavioral therapy and counseling, acupuncture, and botulinum toxin injections (Freund 2000). However, no single treatment has been found to be significantly superior to the others (Freund 2000).

This is a randomized, double-blind, placebo-controlled multicenter study. ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18-65 years of age
• • Ability to give informed consent
• • Myofascial pain of masticatory muscles as defined according to the RDC/TMD criteria
• • Baseline pain measured by the subject ≥3.5/10 on visual analog scale
• Exclusion Criteria:
• • Baseline pain measured by the subject \<3.5/10 on visual analog scale
• • Central/Neuropathic pain disorder affecting the masticatory muscles
• • Temporomandibular Joint Arthralgia that is more severe than the myofascial pain disorder affecting the masticatory muscles
• • Previous Temporomandibular Joint Surgery
• • Systemic arthropathies
• • Fibromyalgia
• • Allergy to study medications
• • Traumatic injury of masticatory muscles or temporomandibular joint within last 12 months
• • Mandibular fracture within last 12 months
• • Pregnancy or breast feeding
• • Cervical radiculopathy or surgery
• • Prior botox injection in the masticatory muscles
• • Initiation of additional treatment of MPD within the past 3 months