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

Arthralgia Clinical Trial

Official title:

PhaseIV Study of Intra-articular Methylprednisolone in TMJ Arthralgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01995019
• Other study ID #: Artralgia1
• Secondary ID: 2013-003365-34
• Status: Completed
• Phase: Phase 4
• First received: November 20, 2013
• Last updated: May 18, 2017
• Start date: December 10, 2013
• Est. completion date: March 15, 2017

Study information

• Verified date: May 2017
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: March 15, 2017
• Est. primary completion date: March 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthralgia
• TMJ

Intervention

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

Locations

Country	Name	City	State
Sweden	Orofacial pain unit, Malar Hospital Eskilstuna	Eskilstuna	Södermanland
Sweden	Specialist clinic Stomatognathic physiology	Goteborg	VastraGotaland
Sweden	Orofacial pain unit, Dental Specialist Education Center	Örebro
Sweden	Orofacial pain unit Eastman Institute	Stockholm
Sweden	Specialist center	Uddevalla	VastraGotaland
Sweden	Dental specialist clinic Kaniken	Uppsala	Uppland
Sweden	Orofacial pain unit, Västmanland Hospital Västerås	Västerås	Västmanland

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Instrument measures	JFLS GCPS PHQ-9 PGIC	4 weeks
Secondary	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