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

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

Tracking Information
First Submitted Date  ICMJE November 20, 2013
First Posted Date  ICMJE November 26, 2013
Last Update Posted Date May 19, 2017
Actual Study Start Date  ICMJE December 10, 2013
Actual Primary Completion Date March 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2013)
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 Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2013)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Arthralgia of the Temporomandibular Joint. Pain Relief Following One Intra-articular Injection of Methylprednisolone
Official Title  ICMJE 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 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Arthralgia
  • TMJ
Intervention  ICMJE
  • Drug: Methylprednisolone
    1 ml single dose Intra-articular Depo-Medrol 40 mg/ml
    Other Name: Depo-Medrol 40 mg/ml
  • Drug: Physiologic saline
    1 ml intra-articular placebo
    Other Name: Sham substance
Study Arms  ICMJE
  • Placebo Comparator: Physiologic saline
    Sodium chloride 9 mg/ml liquid for parental use
    Intervention: Drug: Methylprednisolone
  • Experimental: Methylprednisolone
    Depo-Medrol 40 mg/ml, single dose, injection, intra-articular
    Intervention: Drug: Physiologic saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 18, 2017)
56
Original Estimated Enrollment  ICMJE
 (submitted: November 20, 2013)
64
Actual Study Completion Date  ICMJE March 15, 2017
Actual Primary Completion Date March 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01995019
Other Study ID Numbers  ICMJE Artralgia1
2013-003365-34 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Uppsala University
Study Sponsor  ICMJE Uppsala University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Göran Isacsson, DDS Orofacial pain unit, Västmanland Hospital Västerås
PRS Account Uppsala University
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP