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

NCT02230371 | Completed Phase 4

• 2 other identifiers: NC32005-006042-41
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Myofascial Pain; Temporomandibular Disorders

Keywords

Myofascial pain; TMD; 5-HT3; Granisetron; Placebo-controlled; Patients; Randomized; Double-blind

Outcome Measures

Primary Outcomes (2)

• Pain intensity

  Change of the median weekly pain intensity compared to baseline A 100-mm VAS is used for each day of the week

  8 weeks after treatment

• Pain intensity

  Change of the median weekly pain intensity compared to baseline A 100-mm VAS is used for each day of the week

  6 months after treatment

Secondary Outcomes (7)

• Physical and emotional functioning

  8 weeks after treatment

• Physical and emotional functioning

  6 months after treatment

• Adverse events

  1 week after the first injection

• Adverse events

  1 week after the second injection

• Adverse events

  1 week after the third injection

Other Outcomes (2)

• Changes in pressure pain threshold

  8 weeks after treatment

• Changes in pressure pain threshold

  6 months after treatment

Study Arms (2)

Granisetron

EXPERIMENTAL

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

Control (placebo)

PLACEBO COMPARATOR

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)

Interventions

Granisetron DRUG

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.

Also known as: Kytril (Roche)

Granisetron

Control (placebo) DRUG

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.

Also known as: Isotonic saline 9%

Control (placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Folktandvården Stockholms län AB: collaborator

Study Sites (1)

Karolinska Institutet, Department of Dental Medicine

Huddinge, 141 04, Sweden

Location

Related Publications (10)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Christidis N, Omrani S, Fredriksson L, Gjelset M, Louca S, Hedenberg-Magnusson B, Ernberg M. Repeated tender point injections of granisetron alleviate chronic myofascial pain--a randomized, controlled, double-blinded trial. J Headache Pain. 2015;16:104. doi: 10.1186/s10194-015-0588-3. Epub 2015 Dec 3.

  PMID: 26634569 DERIVED

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Granisetron

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Nikolaos Christidis, PhD, DDS

  Karolinska Institutet, Department of Dental Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor, PhD, DDS, Senior Consultant

Study Record Dates

• First Submitted: August 27, 2014
• First Posted: September 3, 2014
• Study Start: March 1, 2007
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 24, 2021

Record last verified: 2021-03

Locations

SE (1)