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Pain relief following a single dose metylprednisolon vs. placebo injected to the jaw joint in patientens with chronic joint pain. A randomized controlled blinded multicenter study.

Pain relief following an intra-articular single dose metylprednisolon vs. placebo on temporomandibular joint artralgia patientens. A randomized controlled blinded multicenter study. - Metylprednisolon temporomandibular joint

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2013-003365-34-SE
Enrollment
Unknown
Registered
2013-08-27
Start date
2013-10-25
Completion date
Unknown
Last updated
2013-11-04

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

Conditions

Artralgia of the jaw joint

Interventions

Trade Name: Depo-Medrol 40 mg/ml injektionsvätska, suspension Pharmaceutical Form: Suspension for injection Pharmaceutical form of the placebo: Solution for injection Route of administration of the pl

Sponsors

Specialisttandvårdskliniken Västmanlands sjukhus Västerås
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: age 18 or above the diagnosis artralgia in one jaw joint understands Swedish verbally and in written signed informed concent 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 14

Exclusion criteria

Exclusion criteria: noise from affekted joint( clicking or crepitation) polyarthitis/connective tissue disease bilateral artralgia of jaw joint fibromylagia or other generalized pain ongoing virus or bacterial infection ongoing major restaurations in the mouth corticosteroid injection in affekted jaw joint past 6 months previous sugical intervention of affected jaw joint complex psychiatric or psychological condition hypersensitive to local anesthetics hypersensitive to metylprednisolone hemofilia

Design outcomes

Primary

MeasureTime frame
Secondary Objective: The secondary objectivs are to evaluate the relief of jaw pain at rest, mouth opening, jaw function, the consequences of pain and the emotional influence following the treatment. Also the variability of pain 3 days before and 5 days after the treatment as well as during 3 days before end of a one month evaluation period is tracked.;Primary end point(s): The differnce in VAS-rated pain intensity at maximal mouth opening from baseline to end of study;Timepoint(s) of evaluation of this end point: After a month;Main Objective: The primary objective is to evaluate the relief of pain at maximal mouth opening following a single dose intra-articular metylprednisolon (Depo-Medrol®) vs. placebo in patients with artralgia of the temporomandibular joint

Secondary

MeasureTime frame
Secondary end point(s): The differnce in VAS-rated pain intensity at jaw rest from baseline to end of study Maximal opening without pain Maximal opening with pain Maximal assisted mouth opening Instruments JFLS GCPS PHQ-9 PGIC;Timepoint(s) of evaluation of this end point: After a month

Countries

Sweden

Contacts

Public ContactGöran Isacsson

Specialisttandvårdskliniken Västmanlands sjukhus Västerås

goran.isacsson@ltv.se+46767766506

Outcome results

None listed

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