Study on the Effect of Granisetron on Myofascial Pain in the Orofacial Muscles

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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 muscles

The study hypothesis is that local administration of granisetron reduces pain and allodynia/hyperalgesia in patients with chronic myofascial pain in the orofacial muscles and that this effect of granisetron on pain is larger than the effect from placebo

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Karolinska Institutet
• Collaborator: Folktandvården Stockholms län AB
• Treatments: Granisetron

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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