NCT06941636

Botulinumtoxin A as a Treatment for Myalgia and Myofacial Pain in Patient With Temporomandibulardisorders

Botulinumtoxin A as a Treatment for Myalgia and Myofacial Pain in Patient With Temporomandibulardisorders - a Quality Study Associated to a New Treatment Routine

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Region Stockholm · Other Government
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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 of BTX is dose dependent.

Detailed description

The primary goal with this study is to expand treatment modalities for patient with myogenous TMD, and to develop clinical protocols with adequate doses for myogenous TMD. A secondary goal is to study if there are differences in treatment effect between sub-groups of myogenous TMD for more personalised pain-treatment. Hypothesis The investigators hypothesis is that application of BTX into the masseter and temporalis muscle will reduce pain and increase quality of life in patients with myogenous TMD, and that the reduction of pain is only to a certain degree due to the dose. High doses of BTX does not necessarily entail increased reduction of pain or better quality of life. The investigators also hypotheses that the effect may differ in sub-groups of myogenous TMD.

Conditions

• Temporomandibular Disorder

Interventions

Type	Name	Description
DRUG	5U/0,1 ml Botulinum toxin A	Botox® 100 U (AbbVie) will be dissolved in 2 milliliters of room-temperature sterile isotonic saline, resulting in a solution concentration of 5 U/0.1 mL. Each patient will receive a total dose of 50 U, administered bilaterally into the masseter and temporalis muscles.
DRUG	10U/0,1 ml Botulinum toxin A	Botox® 100 U (AbbVie) will be dissolved in 1 milliliters of room-temperature sterile isotonic saline, resulting in a solution concentration of 10 U/0.1 mL. Each patient will receive a total dose of 100 U, administered bilaterally into the masseter and temporalis muscles.

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-04-24
• Last updated: 2025-04-24

Locations

1 site across 1 country: Sweden