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