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Study on Clostridium Botulinum Neurotoxin Type A for Treating Myalgia and Myofascial Pain in Patients with Temporomandibular Disorders

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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 temporomandibular disorder (TMD), a condition that affects the jaw joint and muscles controlling jaw movement. The treatment being tested is an injection of Clostridium botulinum neurotoxin type A, commonly known as Botulinumtoxin A, which is a muscle relaxant. This study aims to determine if these injections can effectively reduce muscle pain in patients with TMD and whether the effectiveness depends on the dose given.

Participants in the study will receive injections of Botulinumtoxin A in specific jaw muscles, namely the masseter and temporal muscles, which are involved in chewing and jaw movement. The study will observe changes in pain levels and assess if different doses of the treatment have varying effects on pain relief. Additionally, the study will look at how the treatment impacts the quality of life, jaw function, and any psychosocial changes in participants.

The study will be conducted over a period, with participants being monitored for changes in their condition. The primary focus is on how pain levels change and whether the dose of Botulinumtoxin A matters for pain relief. Secondary observations will include improvements in quality of life and jaw function, as well as any psychosocial changes experienced by the participants. The study is expected to provide valuable insights into the treatment of myogenous TMD, which is a type of TMD caused by muscle issues.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be informed about the trial's purpose, which is to evaluate the effectiveness of botulinumtoxin A injections for treating muscle-related jaw disorders.

    The patient will be required to meet specific criteria, such as being female, aged 18-45, and having a diagnosis of muscle pain related to jaw disorders.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to evaluate the patient's pain levels and jaw function. This will involve measuring pain using a numerical rating scale and assessing jaw movement.

  3. Step 3

    Treatment administration

    The patient will receive injections of botulinumtoxin A into the masseter and temporal muscles. The dosage and frequency will be determined based on the study protocol.

    The treatment aims to reduce pain and improve jaw function. The effect of different doses will be evaluated to determine if the dose impacts pain relief.

  4. Step 4

    Follow-up assessments

    Regular follow-up assessments will be conducted to monitor changes in pain levels and jaw function. These assessments will help determine the effectiveness of the treatment.

    The patient's quality of life and psychosocial changes will also be evaluated during these follow-ups.

  5. Step 5

    Completion of the study

    The study is expected to conclude by the end of 2025. At this point, a final assessment will be conducted to evaluate the overall outcomes of the treatment.

    The primary focus will be on changes in pain levels and whether the dose of botulinumtoxin A had a significant impact on pain relief.

Who can join the trial?

9 criteria

  • Must be a female.
  • Age should be between 18-45 years.
  • Must have a diagnosis of myalgia (muscle pain), myofacial pain (pain in the muscles and the sheath of tissue that surrounds the muscles), or myofascial pain with referred pain (pain that spreads to other areas) according to specific guidelines called DC/TMD.
  • Must have an average pain level of 3 or more on a scale called NRS for more than three months.
  • Must have received treatment for orofacial pain (pain in the face and mouth area) more than three months ago.
  • Must use adequate contraceptives and have a negative pregnancy test.
  • Can still participate even if they have one or more of the following additional conditions:
    • Disc displacement with or without reduction according to DC/TMD (a condition where the disc in the jaw joint moves out of place).
    • Degenerative joint disease (a condition where the joints wear down over time).
    • Arthralgia (joint pain).

Who cannot join the trial?

4 criteria

  • Only females can participate in this study. Males are not eligible.
  • Participants must be within a specific age range. If you are outside this range, you cannot join the study.
  • If you have any other medical conditions that might interfere with the study, you may be excluded.
  • Individuals considered part of a vulnerable population are not eligible. This means people who might need special protection or care.
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Investigated drugs

Botulinum Toxin A is used in this clinical trial to treat myalgia and myofascial pain in patients with temporomandibular disorders (TMD). The medication is injected into the masseter and temporal muscles to see if it can effectively reduce pain and improve muscle function. The study also aims to determine if the effectiveness of the treatment depends on the amount of the medication used.

What is already known about the treatment

Botulinumtoxin A – This medication is administered through injections directly into the muscles, specifically targeting the masseter and temporal muscles. It is currently being studied in clinical trials as a treatment for myalgia and myofascial pain associated with temporomandibular disorders (TMD). The main therapeutic indication is to alleviate pain and improve muscle function in patients with TMD. At the molecular level, Botulinumtoxin A works by blocking the release of a neurotransmitter called acetylcholine, which reduces muscle contractions and relieves pain. It is classified pharmacologically as a neurotoxin.

Investigated diseases

Temporomandibular Disorder – Temporomandibular disorder (TMD) refers to a group of conditions affecting the temporomandibular joint (TMJ), muscles of mastication, and related structures. It often results in pain or discomfort in the jaw, face, and neck, as well as difficulties in jaw movement. Symptoms may include clicking or popping sounds in the jaw, headaches, and earaches. The disorder can be caused by various factors, including stress, teeth grinding, or injury. Over time, TMD can lead to chronic pain and restricted jaw movement. The condition can vary in severity and may fluctuate over time.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504033-44-00Protocol codeBTXclinicaltrialEAEstimated enrolment1 patientSponsorRegion Stockholm Folktandvarden

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