Botulinumtoxin A as a Treatment for Myalgia and Myofacial Pain in Patient With Temporomandibulardisorders
Recruiting
Phase 3
Interventional Study
Temporomandibular Disorder
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 50
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 90 (estimated)
- Sponsor
- Region Stockholm · Government
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About This Trial
Both patients and remitters ask for treatment with Botulinumtoxin A (BTX) with the hope that it will be an effective aid for pain, but little is known regarding if the effect is dose dependent.
The aim of this project is to investigate if injections with BTX in the masseter- and temporal muscle is an efficient treatment in patient with myogenous temporomandibular disorders (TMD) and if the effect…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Has given a written consent
* Diagnose of myalgia, myofacial pain or myofascial pain with referred pain according
* Average pain due to NRS ≥ 3 for more than three months
* Palpationpain in masseter or temporalis.
* Eventual treatment for orofacial pain \> three months ago.
* …
Contacts