NCT01995019

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

PhaseIV Study of Intra-articular Methylprednisolone in TMJ Arthralgia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Uppsala University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arthralgia
• TMJ

Interventions

Type	Name	Description
DRUG	Methylprednisolone	1 ml single dose Intra-articular Depo-Medrol 40 mg/ml
DRUG	Physiologic saline	1 ml intra-articular placebo

Timeline

• Start date: 2013-12-10
• Primary completion: 2017-03-15
• Completion: 2017-03-15
• First posted: 2013-11-26
• Last updated: 2017-05-19

Locations

7 sites across 1 country: Sweden