<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02230371</url>
  </required_header>
  <id_info>
    <org_study_id>NC3</org_study_id>
    <secondary_id>2005-006042-41</secondary_id>
    <nct_id>NCT02230371</nct_id>
  </id_info>
  <brief_title>Study on the Effect of Granisetron on Myofascial Pain in the Orofacial Muscles</brief_title>
  <official_title>The Serotonin Receptor Type 3 Antagonist Granisetron as a New Treatment Approach for Patients With Chronic Myofascial Pain in the Orofacial Muscles</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Folktandvården Stockholms län AB</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to to investigate if local treatment with intramuscular injections&#xD;
      of granisetron are effective in alleviating pain in patients with chronic myofascial pain in&#xD;
      the orofacial muscles&#xD;
&#xD;
      The study hypothesis is that local administration of granisetron reduces pain and&#xD;
      allodynia/hyperalgesia in patients with chronic myofascial pain in the orofacial muscles and&#xD;
      that this effect of granisetron on pain is larger than the effect from placebo&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This randomized, placebo-controlled, double blind trial (RCT) is carried out during the&#xD;
      period of May 2006 to December 2014 as a multicenter study. The two participating centers are&#xD;
      the Section of Orofacial Pain and Jaw Function, Department of Dental Medicine, Karolinska&#xD;
      Institutet, Sweden and Department of Clinical Oral Physiology at the Eastman Institute,&#xD;
      Folktandvården Stockholms län AB, Stockholm, Sweden. The patients are divided randomly into&#xD;
      two groups that receive either granisetron or placebo. The randomization is performed by&#xD;
      computer (www.randomization.com) by a research assistant not participating in data&#xD;
      collection.&#xD;
&#xD;
      The study comprise seven visits; V1) Screening for study participation, V2) First treatment,&#xD;
      V3) Second treatment, V4) Third treatment, and V5 to V7) Follow-ups at 1, 2 and 12 months&#xD;
      (Fig. Y1) V1 (baseline) include a general health questionnaire, the RDC/TMD Axis II&#xD;
      questionnaires (25), the McGill Pain Questionnaire (MPQ) (27), pain drawings of the lateral&#xD;
      side of the head (each side separately), and a 1-week pain diary. In addition, a clinical&#xD;
      examination according to the RDC/TMD Axis I is performed, including registration of the&#xD;
      maximum voluntary mouth opening capacity (MUMO), and also registration of the pressure pain&#xD;
      threshold (PPT) as well as blood sampling.&#xD;
&#xD;
      V2-V4 include a shortened clinical examination according to RDC including registration of&#xD;
      MUMO and PPT, treatment with intramuscular injections of study substance and a 1-week pain&#xD;
      diary. At V3 and V4 a patient's global assessment of treatment outcome questionnaire is also&#xD;
      included.&#xD;
&#xD;
      V5-V7 include the RDC/TMD Axis II questionnaires, the McGill Pain Questionnaire (MPQ), pain&#xD;
      drawings of the lateral side of the head (each side separately), a 1-week pain diary, a&#xD;
      patient's global assessment of treatment outcome questionnaire, a clinical examination&#xD;
      according to the RDC/TMD Axis I including registration of MUMO and PPT, and registration of&#xD;
      adverse events.&#xD;
&#xD;
      Three orofacial pain specialists (N.C., L.F., B.H.M.) and one dentist attending a specialist&#xD;
      training program (S.O.) will be calibrated in the RDC/TMD examination technique to a gold&#xD;
      standard examiner (M.E.) during one day, and will perform the study. They and the patients&#xD;
      are blinded to group assignment (i.e. study substance) during the entire trial and the&#xD;
      substances used will not be revealed until the last patient has undergone the last follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2007</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain intensity</measure>
    <time_frame>8 weeks after treatment</time_frame>
    <description>Change of the median weekly pain intensity compared to baseline A 100-mm VAS is used for each day of the week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain intensity</measure>
    <time_frame>6 months after treatment</time_frame>
    <description>Change of the median weekly pain intensity compared to baseline A 100-mm VAS is used for each day of the week</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physical and emotional functioning</measure>
    <time_frame>8 weeks after treatment</time_frame>
    <description>Assessed with Axis II of the RDC/TMD (research diagnostic criteria for temporomandibular disorders), including the questionnaires:&#xD;
Graded Chronic Pain Scale SCL-90R</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical and emotional functioning</measure>
    <time_frame>6 months after treatment</time_frame>
    <description>Assessed with Axis II of the RDC/TMD (research diagnostic criteria for temporomandibular disorders), including the questionnaires:&#xD;
Graded Chronic Pain Scale SCL-90R</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>1 week after the first injection</time_frame>
    <description>Any possible adverse event is registered</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>1 week after the second injection</time_frame>
    <description>Any possible adverse event is registered</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>1 week after the third injection</time_frame>
    <description>Any possible adverse event is registered</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>8 weeks after the third injection</time_frame>
    <description>Any possible adverse event is registered</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>6 months after the third injection</time_frame>
    <description>Any possible adverse event is registered</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Changes in pressure pain threshold</measure>
    <time_frame>8 weeks after treatment</time_frame>
    <description>Assessed with a digital algometer (Somedic Sales, Hörby, Sweden)</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in pressure pain threshold</measure>
    <time_frame>6 months after treatment</time_frame>
    <description>Assessed with a digital algometer (Somedic Sales, Hörby, Sweden)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Myofascial Pain</condition>
  <condition>Temporomandibular Disorders</condition>
  <arm_group>
    <arm_group_label>Granisetron</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control (placebo)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Granisetron</intervention_name>
    <description>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.</description>
    <arm_group_label>Granisetron</arm_group_label>
    <other_name>Kytril (Roche)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Control (placebo)</intervention_name>
    <description>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.</description>
    <arm_group_label>Control (placebo)</arm_group_label>
    <other_name>Isotonic saline 9%</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age ≥ 18 years&#xD;
&#xD;
          -  a diagnosis of myofascial pain according to the research diagnostic criteria for TMD&#xD;
             Axis I (RDC/TMD)&#xD;
&#xD;
          -  duration of TMD pain ≥ 3 months&#xD;
&#xD;
          -  self-assessed average myofascial-TMD pain intensity of ≥ 30 mm on a 100-mm visual&#xD;
             analogue scale (VAS) during one week prior to examination&#xD;
&#xD;
          -  familiar pain upon digital palpation of the masseter and/or the temporalis muscles.&#xD;
&#xD;
          -  The patients remain included with one or several co-diagnoses of; a) disc displacement&#xD;
             with or without reduction, b) osteoarthrosis in the any of the temporomandibular&#xD;
             joints (TMJ), and c) episodic or chronic tension type headache&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  diagnosed systemic muscular or joint diseases (e.g. fibromyalgia, rheumatoid&#xD;
             arthritis, ankylosing spondylitis, psoriatic arthritis)&#xD;
&#xD;
          -  whiplash associated disorder&#xD;
&#xD;
          -  neuropathic pain or neurological disorders (e.g. myasthenia gravis, orofacial&#xD;
             dystonia)&#xD;
&#xD;
          -  history of psychiatric disorders&#xD;
&#xD;
          -  pain of dental origin&#xD;
&#xD;
          -  use of muscle relaxants or any medication that might influence the response to pain&#xD;
&#xD;
          -  pregnancy or lactation&#xD;
&#xD;
          -  known hypersensitivity to granisetron&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nikolaos Christidis, PhD, DDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet, Department of Dental Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Karolinska Institutet, Department of Dental Medicine</name>
      <address>
        <city>Huddinge</city>
        <zip>141 04</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <reference>
    <citation>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):265-270. doi: 10.1016/j.pain.2004.10.016.</citation>
    <PMID>15661432</PMID>
  </reference>
  <reference>
    <citation>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. doi: 10.1097/AJP.0b013e318058abb1.</citation>
    <PMID>17575485</PMID>
  </reference>
  <reference>
    <citation>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. doi: 10.1016/s0304-3959(99)00221-3.</citation>
    <PMID>10666539</PMID>
  </reference>
  <reference>
    <citation>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. doi: 10.1016/s0304-3959(99)00233-x.</citation>
    <PMID>10692600</PMID>
  </reference>
  <reference>
    <citation>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. doi: 10.1016/s0024-3205(99)00250-7.</citation>
    <PMID>10447217</PMID>
  </reference>
  <reference>
    <citation>Farber L, Stratz T, Bruckle W, Spath M, Pongratz D, Lautenschlager J, Kotter I, Zoller B, Peter HH, Neeck G, Alten R, Muller 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. doi: 10.1080/030097400446643.</citation>
    <PMID>11028832</PMID>
  </reference>
  <reference>
    <citation>Spath M, Stratz T, Neeck G, Kotter I, Hammel B, Amberger CC, Haus U, Farber L, Pongratz D, Muller W. Efficacy and tolerability of intravenous tropisetron in the treatment of fibromyalgia. Scand J Rheumatol. 2004;33(4):267-70. doi: 10.1080/03009740410005818.</citation>
    <PMID>15370724</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>15515414</PMID>
  </reference>
  <reference>
    <citation>Muller 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.</citation>
    <PMID>15515413</PMID>
  </reference>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>August 27, 2014</study_first_submitted>
  <study_first_submitted_qc>August 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>March 23, 2021</last_update_submitted>
  <last_update_submitted_qc>March 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Nikolaos Christidis</investigator_full_name>
    <investigator_title>Assistant professor, PhD, DDS, Senior Consultant</investigator_title>
  </responsible_party>
  <keyword>Myofascial pain</keyword>
  <keyword>TMD</keyword>
  <keyword>5-HT3</keyword>
  <keyword>Granisetron</keyword>
  <keyword>Placebo-controlled</keyword>
  <keyword>Patients</keyword>
  <keyword>Randomized</keyword>
  <keyword>Double-blind</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myofascial Pain Syndromes</mesh_term>
    <mesh_term>Temporomandibular Joint Disorders</mesh_term>
    <mesh_term>Temporomandibular Joint Dysfunction Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Granisetron</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02230371
org study id: NC3
secondary id: 2005-006042-41
nct id: NCT02230371
lead sponsor: 
collaborator: 
has dmc: No
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
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Pain intensity
time frame: 8 weeks after treatment
description: Change of the median weekly pain intensity compared to baseline A 100-mm VAS is used for each day of the week
measure: Pain intensity
time frame: 6 months after treatment
description: Change of the median weekly pain intensity compared to baseline A 100-mm VAS is used for each day of the week
measure: Physical and emotional functioning
time frame: 8 weeks after treatment
description: Assessed with Axis II of the RDC/TMD (research diagnostic criteria for temporomandibular disorders), including the questionnaires:
Graded Chronic Pain Scale SCL-90R
measure: Physical and emotional functioning
time frame: 6 months after treatment
description: Assessed with Axis II of the RDC/TMD (research diagnostic criteria for temporomandibular disorders), including the questionnaires:
Graded Chronic Pain Scale SCL-90R
measure: Adverse events
time frame: 1 week after the first injection
description: Any possible adverse event is registered
measure: Adverse events
time frame: 1 week after the second injection
description: Any possible adverse event is registered
measure: Adverse events
time frame: 1 week after the third injection
description: Any possible adverse event is registered
measure: Adverse events
time frame: 8 weeks after the third injection
description: Any possible adverse event is registered
measure: Adverse events
time frame: 6 months after the third injection
description: Any possible adverse event is registered
measure: Changes in pressure pain threshold
time frame: 8 weeks after treatment
description: Assessed with a digital algometer (Somedic Sales, Hörby, Sweden)
measure: Changes in pressure pain threshold
time frame: 6 months after treatment
description: Assessed with a digital algometer (Somedic Sales, Hörby, Sweden)
arm group label: Granisetron
arm group type: Experimental
description: 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.
arm group label: Control (placebo)
arm group type: Placebo Comparator
description: 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.
intervention type: Drug
intervention name: Granisetron
description: 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.
arm group label: Granisetron
other name: Kytril (Roche)
intervention type: Drug
intervention name: Control (placebo)
description: 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.
arm group label: Control (placebo)
other name: Isotonic saline 9%
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nikolaos Christidis, PhD, DDS
role: Principal Investigator
affiliation: Karolinska Institutet, Department of Dental Medicine
facility: 
country: Sweden
citation: 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):265-270. doi: 10.1016/j.pain.2004.10.016.
PMID: 15661432
citation: 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. doi: 10.1097/AJP.0b013e318058abb1.
PMID: 17575485
citation: 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. doi: 10.1016/s0304-3959(99)00221-3.
PMID: 10666539
citation: 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. doi: 10.1016/s0304-3959(99)00233-x.
PMID: 10692600
citation: 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. doi: 10.1016/s0024-3205(99)00250-7.
PMID: 10447217
citation: Farber L, Stratz T, Bruckle W, Spath M, Pongratz D, Lautenschlager J, Kotter I, Zoller B, Peter HH, Neeck G, Alten R, Muller 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. doi: 10.1080/030097400446643.
PMID: 11028832
citation: Spath M, Stratz T, Neeck G, Kotter I, Hammel B, Amberger CC, Haus U, Farber L, Pongratz D, Muller W. Efficacy and tolerability of intravenous tropisetron in the treatment of fibromyalgia. Scand J Rheumatol. 2004;33(4):267-70. doi: 10.1080/03009740410005818.
PMID: 15370724
citation: 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.
PMID: 15515414
citation: Muller 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.
PMID: 15515413
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Nikolaos Christidis
investigator title: Assistant professor, PhD, DDS, Senior Consultant
mesh term: Myofascial Pain Syndromes
mesh term: Temporomandibular Joint Disorders
mesh term: Temporomandibular Joint Dysfunction Syndrome
mesh term: Granisetron