Status:
COMPLETED
Study on the Effect of Granisetron on Myofascial Pain in the Orofacial Muscles
Lead Sponsor:
Karolinska Institutet
Collaborating Sponsors:
Folktandvården Stockholms län AB
Conditions:
Myofascial Pain
Temporomandibular Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The aim of this study is to to investigate if local treatment with intramuscular injections of granisetron are effective in alleviating pain in patients with chronic myofascial pain in the orofacial m...
Detailed Description
This randomized, placebo-controlled, double blind trial (RCT) is carried out during the period of May 2006 to December 2014 as a multicenter study. The two participating centers are the Section of Oro...
Eligibility Criteria
Inclusion
- age ≥ 18 years
- a diagnosis of myofascial pain according to the research diagnostic criteria for TMD Axis I (RDC/TMD)
- duration of TMD pain ≥ 3 months
- self-assessed average myofascial-TMD pain intensity of ≥ 30 mm on a 100-mm visual analogue scale (VAS) during one week prior to examination
- familiar pain upon digital palpation of the masseter and/or the temporalis muscles.
- The patients remain included with one or several co-diagnoses of; a) disc displacement with or without reduction, b) osteoarthrosis in the any of the temporomandibular joints (TMJ), and c) episodic or chronic tension type headache
Exclusion
- diagnosed systemic muscular or joint diseases (e.g. fibromyalgia, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis)
- whiplash associated disorder
- neuropathic pain or neurological disorders (e.g. myasthenia gravis, orofacial dystonia)
- history of psychiatric disorders
- pain of dental origin
- use of muscle relaxants or any medication that might influence the response to pain
- pregnancy or lactation
- known hypersensitivity to granisetron
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02230371
Start Date
March 1 2007
End Date
December 1 2014
Last Update
March 24 2021
Active Locations (1)
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1
Karolinska Institutet, Department of Dental Medicine
Huddinge, Sweden, 141 04