Validation of experimental pain models as translational for craniofacial myalgia with respect to the influence of 5-HT, glutamate, cortisol and estradiol level

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-000746-32-SE

Enrollment

240

Registered

2008-02-29

Start date

2008-04-23

Completion date

Unknown

Last updated

2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with craniomandibular myalgia (CM), i.e. with pain in the masster muscle and a diagnosis of myofascial pain according to the RDC/TMD criteria, and healthy subjects of both sexes, over 18 years of age are included.

Interventions

Trade Name: Kytril Pharmaceutical Form: Injection* Pharmaceutical form of the placebo: Injection* Route of administration of the placebo: Intramuscular use Trade Name: Ketalar Pharmaceutical Form: I

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy subjects: - age over 18 - good general health Patients: - age over 18 - the diagnosis myofascial pain according to the RDC/TMD-criteria - pain from the masseter muscle Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Healthy subjects: - pain from the masseter muscle and/or the anterior tibial muscle All: - use of analgesics, anti-inflammatory drugs or muskelrelaxerants during 3 days - systemic inflammatory diseases (such as rheumatoid arthritis, psoriatic arthritis, ankylotic spondylitis) - whiplash associated disorder - fibromyalgia - neuropatic pain or neurologic disease (such as myastena gravis, craniomandibular dystonia) - toothache - pregnancy or lactation - known allergic reaction to granisetron or ketamine

Design outcomes

Primary

Measure	Time frame
Main Objective: The overall aim for the research project is to gain better understanding of the pathophysiology behind chronic craniomandibular myalgia (CM) by using different experimental pain models and validate them as translational. Special emphasis is directed towards pain modulation and the involvement by 5-HT and glutamate in relation to gender and stress level.;Secondary Objective: ;Primary end point(s): Our primary end point is when the last subject undergoing the trial has been on the last visit.	—

Measure

Time frame

Main Objective: The overall aim for the research project is to gain better understanding of the pathophysiology behind chronic craniomandibular myalgia (CM) by using different experimental pain models and validate them as translational. Special emphasis is directed towards pain modulation and the involvement by 5-HT and glutamate in relation to gender and stress level.;Secondary Objective: ;Primary end point(s): Our primary end point is when the last subject undergoing the trial has been on the last visit.

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Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026