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Effects by botulinum toxin in patients with jaw muscle pai

Phase 1
Conditions
Myogenous temporomandibular disorders (TMDM)
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Registration Number
CTIS2024-514739-12-00
Lead Sponsor
Karolinska Institutet
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
Not specified
Target Recruitment
40
Inclusion Criteria

A diagnosis of myalgia or myofascial pain with referral according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) axix I, Female aged 20 – 45 years, A characteristic pain intensity of > 40/100, Pain upon digital palpation of at least one of the masseter muscles

Exclusion Criteria

Difficulties understanding the Swedish language, Known allergy to botulinum toxin or antibiotics, Use of muscle relaxants, antidepressant, neuropsychiatric, or anticoagulant drugs, Use of analgesic or anti-inflammatory medication during the 48 hours preceding biopsy, Previous treatment with BTX during the last 12 months, Infection at the injection site, Systemic inflammatory connective tissue diseases (e.g. rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis) c) widespread pain (e.g. fibromyalgia), Widespread pain (e.g. fibromyalgia), Neuromuscular disorders (e.g. craniomandibular dystonia, myasthenia gravis), Diagnosed or severe psychiatric disease (e.g. schizophrenia, bipolar disorder), Neuropathic pain, Pain of dental origin, History of trauma to the face, head or neck (incl. orthognathic surgery), Pregnancy or nursing

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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