ocal treatment of craniomandibular myofascial pain with the 5-HT3 receptor antagonist granisetron. A randomized and double-blind study. - Granisetron for myofascial pai
- Conditions
- Craniomandibular myalgia
- Registration Number
- EUCTR2005-006042-41-SE
- Lead Sponsor
- Karolinska Institutet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 40
Inclusion criteria are:
1) age > 18 years
2) a diagnosis of myofascial pain according to the research diagnostic criteria (RDC; Dworkin and LeResche, 1992)
3) craniofacial pain = 3 months with an average pain intensity of = 30 mm on a visual analogue scale (VAS) during one week prior to examination
4) pain upon digital palpation of the masseter and/or the temporalis muscle
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria are:
1) systemic inflammatory connective tissue diseases (e.g. rheumatoid arthritis, ankylosing spondylitis, psoriatric arthritis)
2) whiplash associated disorder (WAD)
3) fibromyalgia
4) neuropathic pain or neurological disorders (e.g. myasthenia gravis, oromandibular dystonia)
5) pain of dental origin
6) use of muscle relaxants
7) pregnancy or lactation
8) known hypersensitivity to granisetron.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The aim for the research project is to investigate if local treatment with granisetron reduces pain in patients with chronic craniomandibular myalgia. ;Secondary Objective: ;Primary end point(s): End point is when the last subject undergoing the trial has been on the last visit, 2 months after treatment.
- Secondary Outcome Measures
Name Time Method