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

Uppsala University

Status and phase: Completed; Phase 4

Conditions: TMJ; Arthralgia

Treatments: Drug: Physiologic saline; Drug: Methylprednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT01995019

Artralgia1

2013-003365-34 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 2 patient groups, including a placebo group

Physiologic saline

Placebo Comparator group

Description:

Sodium chloride 9 mg/ml liquid for parental use

Treatment:

Drug: Methylprednisolone

Methylprednisolone

Experimental group

Description:

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

Treatment:

Drug: Physiologic saline