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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