Study on the Effect of Granisetron on Myofascial Pain in the Orofacial Muscles
Information source: Karolinska Institutet
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Myofascial Pain; Temporomandibular Disorders
Intervention: Granisetron (Drug); Control (placebo) (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Karolinska Institutet Official(s) and/or principal investigator(s): Nikolaos Christidis, PhD, DDS, Principal Investigator, Affiliation: Karolinska Institutet, Department of Dental Medicine
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
Clinical Details
Official title: The Serotonin Receptor Type 3 Antagonist Granisetron as a New Treatment Approach for Patients With Chronic Myofascial Pain in the Orofacial Muscles
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Pain intensityPain intensity
Secondary outcome: Physical and emotional functioningPhysical and emotional functioning Adverse events Adverse events Adverse events Adverse events Adverse events
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 Orofacial Pain and Jaw Function, Department of Dental Medicine,
Karolinska Institutet, Sweden and Department of Clinical Oral Physiology at the Eastman
Institute, Folktandvården Stockholms län AB, Stockholm, Sweden. The patients are divided
randomly into two groups that receive either granisetron or placebo. The randomization is
performed by computer (www. randomization. com) by a research assistant not participating in
data collection.
The study comprise seven visits; V1) Screening for study participation, V2) First treatment,
V3) Second treatment, V4) Third treatment, and V5 to V7) Follow-ups at 1, 2 and 12 months
(Fig. Y1) V1 (baseline) include a general health questionnaire, the RDC/TMD Axis II
questionnaires (25), the McGill Pain Questionnaire (MPQ) (27), pain drawings of the lateral
side of the head (each side separately), and a 1-week pain diary. In addition, a clinical
examination according to the RDC/TMD Axis I is performed, including registration of the
maximum voluntary mouth opening capacity (MUMO), and also registration of the pressure pain
threshold (PPT) as well as blood sampling.
V2-V4 include a shortened clinical examination according to RDC including registration of
MUMO and PPT, treatment with intramuscular injections of study substance and a 1-week pain
diary. At V3 and V4 a patient's global assessment of treatment outcome questionnaire is also
included.
V5-V7 include the RDC/TMD Axis II questionnaires, the McGill Pain Questionnaire (MPQ), pain
drawings of the lateral side of the head (each side separately), a 1-week pain diary, a
patient's global assessment of treatment outcome questionnaire, a clinical examination
according to the RDC/TMD Axis I including registration of MUMO and PPT, and registration of
adverse events.
Three orofacial pain specialists (N. C., L. F., B. H.M.) and one dentist attending a specialist
training program (S. O.) will be calibrated in the RDC/TMD examination technique to a gold
standard examiner (M. E.) during one day, and will perform the study. They and the patients
are blinded to group assignment (i. e. study substance) during the entire trial and the
substances used will not be revealed until the last patient has undergone the last
follow-up.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Karolinska Institutet, Department of Dental Medicine, Huddinge 141 04, Sweden
Additional Information
Related publications: Christidis N, Kopp S, Ernberg M. The effect on mechanical pain threshold over human muscles by oral administration of granisetron and diclofenac-sodium. Pain. 2005 Feb;113(3):265-70. Christidis N, Nilsson A, Kopp S, Ernberg M. Intramuscular injection of granisetron into the masseter muscle increases the pressure pain threshold in healthy participants and patients with localized myalgia. Clin J Pain. 2007 Jul-Aug;23(6):467-72. Ernberg M, Lundeberg T, Kopp S. Effect of propranolol and granisetron on experimentally induced pain and allodynia/hyperalgesia by intramuscular injection of serotonin into the human masseter muscle. Pain. 2000 Feb;84(2-3):339-46. Ernberg M, Lundeberg T, Kopp S. Pain and allodynia/hyperalgesia induced by intramuscular injection of serotonin in patients with fibromyalgia and healthy individuals. Pain. 2000 Mar;85(1-2):31-9. Ernberg M, Hedenberg-Magnusson B, Alstergren P, Kopp S. The level of serotonin in the superficial masseter muscle in relation to local pain and allodynia. Life Sci. 1999;65(3):313-25. Färber L, Stratz T, Brückle W, Späth M, Pongratz D, Lautenschläger J, Kötter I, Zöller B, Peter HH, Neeck G, Alten R, Müller W. Efficacy and tolerability of tropisetron in primary fibromyalgia--a highly selective and competitive 5-HT3 receptor antagonist. German Fibromyalgia Study Group. Scand J Rheumatol Suppl. 2000;113:49-54. Späth M, Stratz T, Neeck G, Kötter I, Hammel B, Amberger CC, Haus U, Färber L, Pongratz D, Müller W. Efficacy and tolerability of intravenous tropisetron in the treatment of fibromyalgia. Scand J Rheumatol. 2004;33(4):267-70. Ettlin T. Trigger point injection treatment with the 5-HT3 receptor antagonist tropisetron in patients with late whiplash-associated disorder. First results of a multiple case study. Scand J Rheumatol Suppl. 2004;119:49-50. Müller W, Stratz T. Local treatment of tendinopathies and myofascial pain syndromes with the 5-HT3 receptor antagonist tropisetron. Scand J Rheumatol Suppl. 2004;119:44-8.
Starting date: March 2007
Last updated: March 30, 2015
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