Clinical trial NCT01995019: Arthralgia of the Temporomandibular Joint. Pain Relief Following One Intra-articular Injection of Methylprednisolone
Official title: PhaseIV Study of Intra-articular Methylprednisolone in TMJ Arthralgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arthralgia
TMJ
Keywords: Arthralgia
Temporomandibular joint
corticosteroids
injection
intra-articular
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2013-11-26
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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, erythromycin, pentobarbital, itraconazole, ketoconazole, Rifampicin, Acetylsalicylic acid, Oral anticoagulant
* mentally retarded

Primary outcomes:
measure: VAS pain score change at maximal mouth opening
timeFrame: 4 weeks
Secondary outcomes:
measure: VAS pain score change at jaw rest
timeFrame: 4 weeks
measure: Instrument measures
timeFrame: 4 weeks
measure: Adverse events
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Eskilstuna
country: Sweden
facility: Orofacial pain unit, Malar Hospital Eskilstuna
state: Södermanland
city: Uppsala
country: Sweden
facility: Dental specialist clinic Kaniken
state: Uppland
city: Goteborg
country: Sweden
facility: Specialist clinic Stomatognathic physiology
state: VastraGotaland
city: Uddevalla
country: Sweden
facility: Specialist center
state: VastraGotaland
city: Västerås
country: Sweden
facility: Orofacial pain unit, Västmanland Hospital Västerås
state: Västmanland
city: Stockholm
country: Sweden
facility: Orofacial pain unit Eastman Institute
city: Örebro
country: Sweden
facility: Orofacial pain unit, Dental Specialist Education Center
Study officials:
affiliation: Orofacial pain unit, Västmanland Hospital Västerås
name: Göran Isacsson, DDS
role: PRINCIPAL_INVESTIGATOR
References: