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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-10

Study Completion Date

2017-03-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Arthralgia TMJ

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Physiologic saline

Sodium chloride 9 mg/ml liquid for parental use

Group Type PLACEBO_COMPARATOR

Methylprednisolone

Intervention Type DRUG

1 ml single dose Intra-articular Depo-Medrol 40 mg/ml

Methylprednisolone

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

Group Type EXPERIMENTAL

Physiologic saline

Intervention Type DRUG

1 ml intra-articular placebo

Interventions

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Methylprednisolone

1 ml single dose Intra-articular Depo-Medrol 40 mg/ml

Intervention Type DRUG

Physiologic saline

1 ml intra-articular placebo

Intervention Type DRUG

Other Intervention Names

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Depo-Medrol 40 mg/ml Sham substance

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No