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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.


Detailed Summary:

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.


Sponsor: Uppsala University

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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?"



Original Secondary Outcome: Same as current

Information By: Uppsala University

Dates:
Date Received: November 20, 2013
Date Started: December 10, 2013
Date Completion:
Last Updated: May 18, 2017
Last Verified: May 2017