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Completed

NCT Number: NCT01995019

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Orofacial pain unit, Malar Hospital Eskilstuna, Eskilstuna, Södermanland County, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methylprednisolone

Drug

1 ml single dose Intra-articular Depo-Medrol 40 mg/ml

Other names: Depo-Medrol 40 mg/ml

Physiologic saline

Drug

1 ml intra-articular placebo

Other names: Sham substance

Primary outcomes

  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 outcomes

  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?"

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Official study title

PhaseIV Study of Intra-articular Methylprednisolone in TMJ Arthralgia

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Nov 26, 2013
Registry last updated
May 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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