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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Changes in pain and impact of doses on pain relief [Срок оценки: Six months]

Вторичные конечные точки (4)

• Changes in quality of life according to The Oral Healthy Impact profile questionnaire (OHIP-5) [Срок оценки: 6 months]
• Maximum jaw opening in millimeter, with and without pain will be compared to asess treatment outcomes. [Срок оценки: 6 months]
• Changes i pressure pain threshold (PPT) [Срок оценки: 6 months]
• Changes in psychological factors [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Швеция · 1 центр

• Eastman institute Folktandvården Region Stockholm — Stockholm

Идентификаторы

NCT: NCT06941636 · 2023-504033-44-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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