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Study on the Effects of Botulinum Toxin in Patients with Jaw Muscle Pain (TMD)

Registered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for a condition known as myogenous temporomandibular disorders (TMD), which is a type of jaw muscle pain. The treatment being tested is botulinum toxin, commonly known for its use in reducing muscle tension. The purpose of the study is to explore how this treatment might change certain biological markers in the jaw muscles of patients with TMD.

Participants in the study will receive an injection of botulinum toxin directly into the jaw muscle. This is done to see if it can help reduce the pain and alter specific biological processes in the muscle. The study will also involve a comparison with a placebo to understand the true effects of the treatment. The treatment period is relatively short, lasting only a few days, and involves a single injection.

The study aims to observe changes in the jaw muscle's biological markers and pain levels after the treatment. These markers include gene expressions and other cellular changes that might be influenced by the botulinum toxin. The results will help determine if this treatment can effectively reduce jaw muscle pain and provide insights into the underlying mechanisms of TMD.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    An initial assessment is conducted to confirm eligibility for the trial. This includes verifying a diagnosis of myalgia or myofascial pain with referral, as per the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) axis I.

    Eligibility criteria include being female, aged 20 to 45 years, with a characteristic pain intensity greater than 40 out of 100, and experiencing pain upon digital palpation of at least one of the masseter muscles.

  2. Step 2

    Treatment administration

    The treatment involves the administration of botulinum toxin through an intramuscular injection. The specific dosage and frequency are determined by the study protocol and are administered by a healthcare professional.

  3. Step 3

    Monitoring and follow-up

    Regular monitoring is conducted to observe any changes in gene expressions, epigenetic signatures, and cell plasticity in the masseter muscle. This is a primary endpoint of the study.

    Secondary endpoints include assessing changes in jaw muscle pain intensity after treatment.

  4. Step 4

    Completion of trial

    The trial is estimated to conclude by March 31, 2025. Upon completion, data collected will be analyzed to determine the effects of the treatment.

Who can join the trial?

4 criteria

  • Must have a diagnosis of myalgia or myofascial pain with referral. This means experiencing muscle pain or pain in the tissues that connect muscles, as identified by specific criteria for jaw-related disorders.
  • Must be a female aged between 20 and 45 years.
  • Must have a characteristic pain intensity greater than 40 out of 100. This refers to how strong the pain feels, measured on a scale from 0 to 100.
  • Must experience pain when pressing on at least one of the masseter muscles. These are the muscles located at the sides of your jaw, used for chewing.

Who cannot join the trial?

4 criteria

  • Patients who are not female cannot participate in the study.
  • Patients who are under 18 years old cannot participate in the study.
  • Patients who do not have myogenous temporomandibular disorders (TMDM) cannot participate. This condition involves problems with the muscles around the jaw.
  • Patients who are considered part of a vulnerable population cannot participate. This means people who might need extra protection or care.
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Investigated drugs

Botulinum Toxin A is a medication used in this clinical trial to study its effects on patients with temporomandibular disorder (TMD) pain. The trial aims to see if this treatment can change gene expressions, epigenetic markers, and cell behavior in the masseter muscle, which is a muscle involved in jaw movement. Botulinum Toxin A is commonly known for its ability to relax muscles and is often used in various medical and cosmetic treatments to reduce muscle tension and pain.

What is already known about the treatment

Botulinum Toxin A – This medication is administered through injection directly into the affected muscles. It is currently being studied for its effects on myogenous temporomandibular disorders (TMDM) and is well-documented in medical literature for various uses. The main therapeutic indication for this trial is to alleviate pain associated with TMDM. At the molecular level, Botulinum Toxin A works by blocking the release of a neurotransmitter called acetylcholine, which reduces muscle contractions and pain. It is classified pharmacologically as a neurotoxin.

Investigated diseases

Myogenous Temporomandibular Disorders – This condition involves pain and dysfunction in the muscles that control jaw movement, particularly the masseter muscle. It is characterized by muscle tenderness, limited jaw movement, and pain that can radiate to the face, neck, or shoulders. The disorder often results from muscle overuse, stress, or misalignment of the jaw. Symptoms may include difficulty chewing, jaw locking, and a clicking or popping sound when opening or closing the mouth. Over time, the condition can lead to chronic discomfort and affect daily activities such as eating and speaking.
Trial detailsLast updated 14 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514739-12-00Protocol codeBTXclintrialv1Estimated enrolment100 patientsSponsorKarolinska Institutet

sourced from the EU Clinical Trials Register and site verification

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