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

Information source: Uppsala University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Arthralgia; TMJ

Intervention: Methylprednisolone (Drug); Physiologic saline (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Uppsala University

Official(s) and/or principal investigator(s):
Göran Isacsson, DDS, Principal Investigator, Affiliation: Orofacial pain unit, Västmanland Hospital Västerås

Overall contact:
Göran Isacsson, Ass prof,DDS, Phone: +46 2117 54 85, Email: goran.isacsson@ltv.se


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.

Clinical Details

Official title: PhaseIV Study of Intra-articular Methylprednisolone in TMJ Arthralgia

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: VAS pain score change at maximal mouth opening

Secondary outcome:

VAS pain score change at jaw rest

Instrument measures

Adverse events

Detailed 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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, erytromycin, pentobarbital, itraconazole,

ketoconazole, Rifampicin, Acetylsalicylic acid, Oral anticoagulant

- mentally retarded

Locations and Contacts

Göran Isacsson, Ass prof,DDS, Phone: +46 2117 54 85, Email: goran.isacsson@ltv.se

Orofacial pain unit Eastman Institute, Stockholm 113 24, Sweden; Not yet recruiting
Britt Hedenberg-Magnusson, DDS, dr med, Phone: +468-7298983, Email: britt.hedenberg-magnusson@ftv.sll.se

Orofacial pain unit, Dental Specialist Education Center, Örebro 70111, Sweden; Recruiting
Göran Isacsson, DDS, ass prof, Phone: +4619-6024070, Email: dan.strom@orebvroll.se
Dan Ström, DDS, ass prof, Principal Investigator

Orofacial pain unit, Malar Hospital Eskilstuna, Eskilstuna, Södermanland 631 88, Sweden; Recruiting
Bengt Adern, DDS, Phone: +46 16104651, Email: bengt.adern@dll.se
Bengt Adern, DDS, Principal Investigator

Dental specialist clinic Kaniken, Uppsala, Uppland 75148, Sweden; Not yet recruiting
Erik Lindfors, DDS, Phone: +46 18611 6382, Email: erik.lindfors@lul.se

Specialist clinic Stomatognathic physiology, Goteborg, VastraGotaland 40233, Sweden; Recruiting
Christina Mejersjo, DDS, dr odont, Phone: +46 104417580, Email: christina.mejersjo@vgregion.se

Specialist center, Uddevalla, VastraGotaland 45180, Sweden; Recruiting
Dan Strom, DDS, DDS, Phone: +46 104419001, Email: dan.strom@vgregion.se

Orofacial pain unit, Västmanland Hospital Västerås, Västerås, Västmanland 72185, Sweden; Recruiting
Goran Isacsson, Assoc Prof, Phone: +4621175485, Email: goran.isacsson@ltv.se
Göran Isacsson, DDS,ass prof, Principal Investigator

Additional Information

Starting date: December 2013
Last updated: December 12, 2014

Page last updated: August 23, 2015

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