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Arthralgia | Arthralgia of the Temporomandibular Joint. Pain Relief Following One Intra-articular Injection of Methylprednisolone

Arthralgia research study

What is the primary objective of this study?

The hypothesis is that a single dose intra-articular injection of corticosteroids are effective in relieving temporomandibular arthralgia pain. The purpose of the study is therefore to evaluate the effect of a single dose intra-articular methylprednisolone vs. placebo in a month perspective on subjects with unilateral arthralgia of the TMJ.

Who is eligible to participate?

Inclusion Criteria: - age 18 or above - the diagnosis arthralgia in one TMJ - understands Swedish both verbally and in written - signed informed concent Exclusion Criteria: - TMJ sounds in terms of clicking (crepitation allowed)) - polyarthritis/connective tissue disease - bilateral TMJ arthralgia - fibromyalgia or other generalized pain - ongoing infection - ongoing dental treatment - intra-articular corticosteroid injection of a TMJ the past 6 months - previous surgery of the affected TMJ - complex psychiatric/psychologic status - institutionalized living including prisoners - staff at the investigational clinic - hypersensitive to local anesthetics - hypersensitive to methylprednisolone - hemophilia - methemoglobinemia - nursing - compromized health status according to the judgment of the investigator - concommitant use of the drugs cyclosporine, erythromycin, pentobarbital, itraconazole, ketoconazole, Rifampicin, Acetylsalicylic acid, Oral anticoagulant - mentally retarded

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Arthralgia

TMJ

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Methylprednisolone1 ml single dose Intra-articular Depo-Medrol 40 mg/ml

Drug:Physiologic saline1 ml intra-articular placebo

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Physiologic salineSodium chloride 9 mg/ml liquid for parental use

MethylprednisoloneDepo-Medrol 40 mg/ml, single dose, injection, intra-articular

Study Status

Completed

Start Date: December 10, 2013

Completed Date: March 15, 2017

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: VAS pain score change at maximal mouth opening

Secondary Outcome: VAS pain score change at jaw rest

Study sponsors, principal investigator, and references

Principal Investigator: Göran Isacsson, DDS

Lead Sponsor: Uppsala University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01995019

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