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Search / Trial NCT04426123

Masseter Myofascial Pain Relief Following an Intra-muscular Injection With Botulinum Toxin Type A.

Launched by REGION ÖREBRO COUNTY · Jun 8, 2020

Trial Information

Current as of May 03, 2025

Unknown status

Keywords

ClinConnect Summary

Temporomandibular disorders (TMD) is the second most common musculoskeletal condition (after chronic low back pain) and refer to pain and dysfunction in the temporomandibular system and its muscles, joints, and associated structures. The prevalence of TMD is 4-15% among adults where myalgia is the most common form of TMD.

Diagnostic Criteria for temporomandibular disorders (DC/TMD) was introduced in 2014 and is used worldwide for classifying TMD. Myalgia is the second group of disorders of DC/TMD and is defined by pain in a masticatory structure that is modified by jaw movement, function, ...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • age \> 18 years
  • \> 3-month complaints of jaw/face pain
  • the diagnose myalgia according to DC/TMD
  • understands Swedish verbally and in writing
  • in writing give his/her consent to participate
  • Exclusion Criteria:
  • polyarthritis/connective tissue disease
  • fibromyalgia or other generalized pain
  • neurological disorders
  • whiplash associated disorders
  • ongoing virus or bacterial infection
  • ongoing dental treatment
  • botulinum toxin injection in the jaw or face past six months
  • complex psychiatric/psychological profile, institutional residence
  • employee at the trial clinic, internal resident
  • hypersensitivity to botulinum toxin, human albumin
  • serious health conditions according to the examiner's assessment
  • in the presence of infection at the proposed injection site(s)
  • pregnancy or lactating
  • fertile women not on contraception

About Region örebro County

Region Örebro County is a leading healthcare organization dedicated to advancing medical research and improving patient care through innovative clinical trials. Committed to fostering collaboration between researchers, healthcare professionals, and the community, Region Örebro County facilitates a wide range of studies aimed at evaluating new treatments and interventions across various medical fields. By prioritizing patient safety and ethical standards, the region aims to contribute valuable insights that enhance medical knowledge and improve health outcomes for populations both locally and globally.

Locations

Patients applied

0 patients applied

Trial Officials

Göran Isacsson, Assoc. Prof.

Study Director

Region Stockholm

Mohamad Schumann, DDS

Study Director

Västerås

Daniel Ovesson, DDS

Study Director

Karlstad

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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