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

• ClinicalTrials.gov Identifier: NCT01995019
• Recruitment Status: Completed
• First Posted: November 26, 2013
• Last Update Posted: May 19, 2017
• Sponsor: Uppsala University
• Information provided by (Responsible Party): Uppsala University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Arthralgia; TMJ	Drug: Methylprednisolone; Drug: Physiologic saline	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: PhaseIV Study of Intra-articular Methylprednisolone in TMJ Arthralgia
• Actual Study Start Date: December 10, 2013
• Actual Primary Completion Date: March 15, 2017
• Actual Study Completion Date: March 15, 2017

Arms and Interventions

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 Name: 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 Name: Sham substance

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. 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
2. Instrument measures [ Time Frame: 4 weeks ]
   JFLS GCPS PHQ-9 PGIC
3. 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?"

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Sweden

Orofacial pain unit, Malar Hospital Eskilstuna

Eskilstuna, Södermanland, Sweden, 631 88

Dental specialist clinic Kaniken

Uppsala, Uppland, Sweden, 75148

Specialist clinic Stomatognathic physiology

Goteborg, VastraGotaland, Sweden, 40233

Specialist center

Uddevalla, VastraGotaland, Sweden, 45180

Orofacial pain unit, Västmanland Hospital Västerås

Västerås, Västmanland, Sweden, 72185

Orofacial pain unit Eastman Institute

Stockholm, Sweden, 113 24

Orofacial pain unit, Dental Specialist Education Center

Örebro, Sweden, 70111

Sponsors and Collaborators

Uppsala University

Investigators

• Principal Investigator: Göran Isacsson, DDS; Orofacial pain unit, Västmanland Hospital Västerås

More Information

• Responsible Party: Uppsala University
• ClinicalTrials.gov Identifier: NCT01995019
• Other Study ID Numbers: Artralgia1; 2013-003365-34 ( EudraCT Number )
• First Posted: November 26, 2013
• Last Update Posted: May 19, 2017
• Last Verified: May 2017

Keywords provided by Uppsala University:

Arthralgia; Temporomandibular joint; corticosteroids; injection; intra-articular

Additional relevant MeSH terms:

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuroprotective Agents; Protective Agents; Antineoplastic Agents, Hormonal; Antineoplastic Agents