Image

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

Recruiting
18-50 years
Female
Phase 3

Powered by AI

Overview

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.

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.

Eligibility

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.
  • Adequate contraceptives and a negative pregnancy test.

Patients will still be included even if they have one or more co-diagnoses

  • Discdisplacement with or without reduction
  • Degenerative joint disease
  • Arthralgia

Exclusion Criteria:

  • Treatment with BTX during the last 12 months
  • Treatment for orofacial pain within the last 3 months.
  • Systemic inflammatory diseases (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis)
  • Widespread pain e.g., fibromyalgia
  • Neuropathic pain
  • Neurologic disease (myasthenia gravis)
  • Pain of dental origin
  • Use of muscle relaxants, or aminoglycoside antibiotics
  • Pregnancy or nursing
  • Hypersensitivity to BTX
  • Neuropsychiatric conditions.
  • Difficulties understanding the Swedish language

Study details
    Temporomandibular Disorder

NCT06941636

Region Stockholm

16 October 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.