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

PhaseIV Study of Intra-articular Methylprednisolone in TMJ Arthralgia

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.

Study Overview

• Status: Completed
• Conditions: Arthralgia; TMJ
• Intervention / Treatment: Drug: Methylprednisolone; Drug: Physiologic saline

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 4

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 113 24
    • Orofacial pain unit Eastman Institute
  • Örebro, Sweden, 70111
    • Orofacial pain unit, Dental Specialist Education Center
  • Södermanland
    • Eskilstuna, Södermanland, Sweden, 631 88
      • Orofacial pain unit, Malar Hospital Eskilstuna
  • Uppland
    • Uppsala, Uppland, Sweden, 75148
      • Dental specialist clinic Kaniken
  • VastraGotaland
    • Goteborg, VastraGotaland, Sweden, 40233
      • Specialist clinic Stomatognathic physiology
    • Uddevalla, VastraGotaland, Sweden, 45180
      • Specialist center
  • Västmanland
    • Västerås, Västmanland, Sweden, 72185
      • Orofacial pain unit, Västmanland Hospital Västerås

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Uppsala University
• Investigators: Principal Investigator: Göran Isacsson, DDS, Orofacial pain unit, Västmanland Hospital Västerås

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2013
• Primary Completion (Actual): March 15, 2017
• Study Completion (Actual): March 15, 2017

Study Registration Dates

• First Submitted: November 20, 2013
• First Submitted That Met QC Criteria: November 20, 2013
• First Posted (Estimate): November 26, 2013

Study Record Updates

• Last Update Posted (Actual): May 19, 2017
• Last Update Submitted That Met QC Criteria: May 18, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Arthralgia; corticosteroids; injection; intra-articular; Temporomandibular joint
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
• Other Study ID Numbers: Artralgia1; 2013-003365-34 (EudraCT Number)