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

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ClinicalTrials.gov Identifier: NCT02230371
Recruitment Status : Completed
First Posted : September 3, 2014
Last Update Posted : September 4, 2015
Sponsor:
Collaborator:
Folktandvården Stockholms län AB
Information provided by (Responsible Party):
Nikolaos Christidis, Karolinska Institutet

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 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


Condition or disease Intervention/treatment Phase
Myofascial Pain Temporomandibular Disorders Drug: Granisetron Drug: Control (placebo) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : March 2007
Actual Primary Completion Date : May 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Granisetron

Arm Intervention/treatment
Experimental: Granisetron
Granisetron (Kytril®; 1 mg/mL, Roche, Stockholm, Sweden) is injected into a maximum of six muscle sites in each patient. The most painful sites to palpation of the masticatory muscles is chosen, either in the same muscle (maximum 3 sites per muscle) or in a different. The injected volume into each site is0.5 mL, hence the maximum dose of granisetron a patient can receive is 3 mg per treatment. This is repeated after one and two weeks.
Drug: Granisetron
If the patient does not have any pain after the first or second injection of granisetron (Kytril®; 1 mg/mL, Roche, Stockholm, Sweden), there will be no more injections but the patient will still come for the follow ups.
Other Name: Kytril (Roche)

Placebo Comparator: Control (placebo)
Placebo (isotonic saline (NaCl); 0.9 mg/mL, Fresenius Kabi, Uppsala, Sweden) is injected into a maximum of six muscle sites in each patient. The most painful sites to palpation of the masticatory muscles is chosen, either in the same muscle (maximum 3 sites per muscle) or in a different. The injected volume into each site is 0.5 mL. This is repeated after one and two weeks.
Drug: Control (placebo)
If the patient does not have any pain after the first or second injection of granisetron (isotonic saline (NaCl); 0.9 mg/mL, Fresenius Kabi, Uppsala, Sweden), there will be no more injections but the patient will still come for the follow ups.
Other Name: Isotonic saline 9%




Primary Outcome Measures :
  1. Pain intensity [ Time Frame: 8 weeks after treatment ]
    Change of the median weekly pain intensity compared to baseline A 100-mm VAS is used for each day of the week

  2. Pain intensity [ Time Frame: 6 months after treatment ]
    Change of the median weekly pain intensity compared to baseline A 100-mm VAS is used for each day of the week


Secondary Outcome Measures :
  1. Physical and emotional functioning [ Time Frame: 8 weeks after treatment ]

    Assessed with Axis II of the RDC/TMD (research diagnostic criteria for temporomandibular disorders), including the questionnaires:

    Graded Chronic Pain Scale SCL-90R


  2. Physical and emotional functioning [ Time Frame: 6 months after treatment ]

    Assessed with Axis II of the RDC/TMD (research diagnostic criteria for temporomandibular disorders), including the questionnaires:

    Graded Chronic Pain Scale SCL-90R


  3. Adverse events [ Time Frame: 1 week after the first injection ]
    Any possible adverse event is registered

  4. Adverse events [ Time Frame: 1 week after the second injection ]
    Any possible adverse event is registered

  5. Adverse events [ Time Frame: 1 week after the third injection ]
    Any possible adverse event is registered

  6. Adverse events [ Time Frame: 8 weeks after the third injection ]
    Any possible adverse event is registered

  7. Adverse events [ Time Frame: 6 months after the third injection ]
    Any possible adverse event is registered


Other Outcome Measures:
  1. Changes in pressure pain threshold [ Time Frame: 8 weeks after treatment ]
    Assessed with a digital algometer (Somedic Sales, Hörby, Sweden)

  2. Changes in pressure pain threshold [ Time Frame: 6 months after treatment ]
    Assessed with a digital algometer (Somedic Sales, Hörby, Sweden)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02230371


Locations
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Sweden
Karolinska Institutet, Department of Dental Medicine
Huddinge, Sweden, 141 04
Sponsors and Collaborators
Karolinska Institutet
Folktandvården Stockholms län AB
Investigators
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Principal Investigator: Nikolaos Christidis, PhD, DDS Karolinska Institutet, Department of Dental Medicine
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nikolaos Christidis, Assistant professor, PhD, DDS, Senior Consultant, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02230371    
Other Study ID Numbers: NC3
2005-006042-41 ( EudraCT Number )
First Posted: September 3, 2014    Key Record Dates
Last Update Posted: September 4, 2015
Last Verified: September 2015
Keywords provided by Nikolaos Christidis, Karolinska Institutet:
Myofascial pain
TMD
5-HT3
Granisetron
Placebo-controlled
Patients
Randomized
Double-blind
Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Muscular Diseases
Musculoskeletal Diseases
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Joint Diseases
Stomatognathic Diseases
Granisetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action