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

Overview

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 Title of Study: “PhaseIV Study of Intra-articular Methylprednisolone in TMJ Arthralgia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: March 15, 2017

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.

Interventions

  • Drug: Methylprednisolone
    • 1 ml single dose Intra-articular Depo-Medrol 40 mg/ml
  • Drug: Physiologic saline
    • 1 ml intra-articular placebo

Arms, Groups and Cohorts

  • Placebo Comparator: Physiologic saline
    • Sodium chloride 9 mg/ml liquid for parental use
  • Experimental: Methylprednisolone
    • Depo-Medrol 40 mg/ml, single dose, injection, intra-articular

Clinical Trial Outcome Measures

Primary Measures

  • VAS pain score change at maximal mouth opening
    • Time Frame: 4 weeks
    • 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

Secondary Measures

  • VAS pain score change at jaw rest
    • Time Frame: 4 weeks
    • 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
  • Instrument measures
    • Time Frame: 4 weeks
    • JFLS GCPS PHQ-9 PGIC
  • Adverse events
    • Time Frame: 4 weeks
    • 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?”

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Uppsala University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Göran Isacsson, DDS, Principal Investigator, Orofacial pain unit, Västmanland Hospital Västerås

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