By InvitationNot Applicable

Botulinum Toxin in the Management of Temporo-mandibular Related Myalgia: a Prospective Study

Netherlands30 participantsStarted 2024-01-26

Plain-language summary

The aim of this study was to evaluate the clinical course in terms of pain, function and quality of life of patients with TMD-related myalgia during six months after receiving BTX-A injections. The research question was: What are the outcomes in pain, quality of life and function of patients with TMD-related myalgia receiving BTX-A during 6 months? The hypothesis to be tested was that patients receiving a BTX-A injection due to TMD-related myalgia will have a reduction in pain and increase in quality of life and function after one, three- and six- months.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * TMD-related myalgia in accordance with the DC/TMD; * Accepted BTX-A injections as treatment; * Age ≥ 18 years; * Understanding of the Dutch language to fill in the questionnaires. Exclusion Criteria: * Systemic inflammatory and connective tissue diseases (e.g., rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis); * Surgery in the TMJ area \< 12 months ago; * Pain of dental origin; * Limited cognitive functioning (not allowed to make medical decisions); * Use of muscle relaxants, or aminoglycoside antibiotics; * A history of allergic reactions to BTX; * Pregnancy and lactation.

What they're measuring

Change from baseline in the mean pain rated with the VAS at 1, 3 and 6 months

Timeframe: Baseline, 1, 3 and 6 months

Trial details

NCT IDNCT06677216

SponsorDiakonessenhuis, Utrecht

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-12-31

View on ClinicalTrials.gov More TMD/Orofacial Pain trials