Phase 3
N=75
Botulinum Toxin Versus Placebo Injections to Temporalis and Masseter Muscles
Pain, Head · Pain Syndrome · Temporomandibular Disorder · Myofascial Pain Syndrome · Myofascial Pain
Bottom Line
View on ClinicalTrials.gov: NCT03223298 ↗Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcome: Primary: Change in Jaw Pain as Reported by Patient on Visual Analog Scale (VAS) — 58; 54; -19; -14 score on a scale — p=0.80
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Botulinum toxin type A (Drug); 0.9% Sodium Chloride Injection (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Jaw Pain as Reported by Patient on Visual Analog Scale (VAS) |
58; 54; -19; -14; -18; -18 | 0.80 |
| SECONDARY Jaw Function as Measured by Jaw Function Limitation Scale |
0.38; 0.38; 0.38; 0.25; 0.25; 0.25 | 0.50 |
| SECONDARY Change in Jaw Function as Measured by Maximum Interincisal Opening (MIO) |
41; 42; 34; 34; 0; 2 | 0.30 |
| SECONDARY Change in Objectively Assessed Quality of Life as Measured by Short Form 36 |
100; 100; 0; 0; 0; 0 | 0.40 |
Summary
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
- 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
Data sourced from ClinicalTrials.gov (NCT03223298). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.