Status:

UNKNOWN

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

Lead Sponsor:

Region Örebro County

Collaborating Sponsors:

Region Västmanland

Landstinget i Värmland

Conditions:

Myalgia

Myofascial Pain

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

Investigating the effect of a single intramuscular injection with botulinum toxin (BTX) compared to NaCl in patients with jaw muscle myalgia. This investigation is designed as an double blind multice...

Detailed Description

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, j...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

July 1 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2021

Estimated Enrollment :

48 Patients enrolled

Trial Details

Trial ID

NCT04426123

Start Date

July 1 2020

End Date

December 31 2021

Last Update

June 11 2020

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