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

NCT06677216 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2024-11-06

No results posted yet for this study

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.

Conditions

  • TMD/Orofacial Pain
  • Myalgia of Mastication Muscle
  • Botulinum Toxin, Type a

Interventions

PROCEDURE

Botulinum Toxin, Type A

All participants will receive a solution of BTX-A (Xeomin, Merz Pharma GmbH, Frankfurt am Main, Germany) in the masseter and temporalis muscles (total of 100 units reconstituted with 4cc unpreserved 0.9% sodium chloride). The injection will be provided by the same maxillofacial surgeon. The participants are asked to clench their teeth to determine the site of the most intense muscle activity in the masseter and temporal muscles with palpation. Intramuscular BTX-A injections are administered on both sides at the location of the most intense muscle activity of the masseter (80 units) and temporalis (20 units).

Sponsors & Collaborators

  • Fysiotherapie Utrecht Oost B.V.

    collaborator UNKNOWN

  • Diakonessenhuis, Utrecht

    lead OTHER

Principal Investigators

  • Maurits HT de Ruiter, Dr. · Diakonessenhuis, Utrecht

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-26
Primary Completion
2024-12-31
Completion
2025-02-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06677216 on ClinicalTrials.gov