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

Last updated: May 18, 2017
Sponsor: Uppsala University
Overall Status: Completed

Phase

4

Condition

Muscle Pain

Arthritis And Arthritic Pain

Treatment

N/A

Clinical Study ID

NCT01995019
Artralgia1
2013-003365-34
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • age 18 or above

  • the diagnosis arthralgia in one TMJ

  • understands Swedish both verbally and in written

  • signed informed concent

Exclusion

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

Study Design

Total Participants: 56
Study Start date:
December 10, 2013
Estimated Completion Date:
March 15, 2017

Study Description

This is a randomized blinded multicenter controlled study on 64 subjects (18 years or older) with the diagnosis of unilateral arthralgia of the TMJ.

The subject visit the clinic at three occasions; one enrollment visit, one baseline treatment visit and one evaluation visit one month after baseline.

One week after baseline a follow-up telephone call is made with the purpose to track adverse events.

Pain questionaries are completed morning, lunch and dinnertime during three days before treatment, five days after treatment and three days proceeding the evaluation visit.

The study ís planned to commence 10th December 2013 and last patient out 15th January 2015.

Connect with a study center

  • Orofacial pain unit, Malar Hospital Eskilstuna

    Eskilstuna, Södermanland 631 88
    Sweden

    Site Not Available

  • Dental specialist clinic Kaniken

    Uppsala, Uppland 75148
    Sweden

    Site Not Available

  • Specialist clinic Stomatognathic physiology

    Goteborg, VastraGotaland 40233
    Sweden

    Site Not Available

  • Specialist center

    Uddevalla, VastraGotaland 45180
    Sweden

    Site Not Available

  • Orofacial pain unit, Västmanland Hospital Västerås

    Västerås, Västmanland 72185
    Sweden

    Site Not Available

  • Orofacial pain unit Eastman Institute

    Stockholm, 113 24
    Sweden

    Site Not Available

  • Orofacial pain unit, Dental Specialist Education Center

    Örebro, 70111
    Sweden

    Site Not Available

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