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

Study Overview
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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.

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.

Official Title
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PhaseIV Study of Intra-articular Methylprednisolone in TMJ Arthralgia

Conditions
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Arthralgia, TMJ

Intervention / Treatment
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* Drug: Methylprednisolone
* Drug: Physiologic saline


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Physiologic saline<br>Sodium chloride 9 mg/ml liquid for parental use | Drug: Methylprednisolone<br>* 1 ml single dose Intra-articular Depo-Medrol 40 mg/ml<br>* Other names: Depo-Medrol 40 mg/ml;|
| Experimental: Methylprednisolone<br>Depo-Medrol 40 mg/ml, single dose, injection, intra-articular | Drug: Physiologic saline<br>* 1 ml intra-articular placebo<br>* Other names: Sham substance;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS pain score change at maximal mouth opening | 100 mm analog Visual Analog Scale with endpoints No pain and Worst pain imaginable The intra-individual change of the VAS pain score between baseline and end of study | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS pain score change at jaw rest | 100 mm analog Visual Analog Scale with endpoints No pain and Worst pain imaginable The intra-individual change of the VAS pain score between baseline and end of study | 4 weeks | 
| Instrument measures | JFLS GCPS PHQ-9 PGIC | 4 weeks | 
| Adverse events | Spontaneously reported by the subject or observed by the study staff from the baseline visit until the evaluation visit. Reported by the subject in response to open questioning at visits/phone calls from the baseline visit until the evaluation visit Have you had any health problems since your last visit/contact? | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthralgia, Temporomandibular joint, corticosteroids, injection, intra-articular