Phase 3
Completed N=75
Botulinum Toxin Versus Placebo Injections to Temporalis and Masseter Muscles
Pain, Head · Pain Syndrome · temporomandibular disorder · Postoperative Pain
Source: ClinicalTrials.gov NCT03223298 ↗
Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcomePrimary: Change in Jaw Pain as Reported by Patient on Visual Analog Scale (VAS) — 58; 54; -19; -14 score on a scale — p=0.80
◆ Published Evidence
Emerging
8citations · ~4 / year
Does the Use of Botulinum Toxin in Treatment of Myofascial Pain Disorder of the Masseters and Temporalis Muscles Reduce Pain, Improve Function, or Enhance Quality of Life?
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.
Linked Publications
-
Does the Use of Botulinum Toxin in Treatment of Myofascial Pain Disorder of the Masseters and Temporalis Muscles Reduce Pain, Improve Function, or Enhance Quality of Life?
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 |
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) and the linked publication. 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. Informational only — not medical advice.