NCT01995019

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2013

Typical duration for phase_4

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 26, 2013

Completed
14 days until next milestone

Study Start

First participant enrolled

December 10, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2017

Completed
Last Updated

May 19, 2017

Status Verified

May 1, 2017

Enrollment Period

3.3 years

First QC Date

November 20, 2013

Last Update Submit

May 18, 2017

Conditions

ArthralgiaTMJ

Keywords

ArthralgiaTemporomandibular jointcorticosteroidsinjectionintra-articular

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • VAS pain score change at jaw rest

    4 weeks

  • Instrument measures

    4 weeks

  • Adverse events

    4 weeks

Study Arms (2)

Physiologic saline

PLACEBO COMPARATOR

Sodium chloride 9 mg/ml liquid for parental use

Drug: Methylprednisolone

Methylprednisolone

EXPERIMENTAL

Depo-Medrol 40 mg/ml, single dose, injection, intra-articular

Drug: Physiologic saline

Interventions

MethylprednisoloneDRUG

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

Also known as: Depo-Medrol 40 mg/ml
Physiologic saline
Physiologic salineDRUG

1 ml intra-articular placebo

Also known as: Sham substance
Methylprednisolone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18 or above
  • the diagnosis arthralgia in one TMJ
  • understands Swedish both verbally and in written
  • signed informed concent

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Orofacial pain unit, Malar Hospital Eskilstuna

Eskilstuna, Södermanland County, 631 88, Sweden

Location

Dental specialist clinic Kaniken

Uppsala, Uppland, 75148, Sweden

Location

Specialist clinic Stomatognathic physiology

Gothenburg, VastraGotaland, 40233, Sweden

Location

Specialist center

Uddevalla, VastraGotaland, 45180, Sweden

Location

Orofacial pain unit, Västmanland Hospital Västerås

Västerås, Västmanland County, 72185, Sweden

Location

Orofacial pain unit, Dental Specialist Education Center

Örebro, 70111, Sweden

Location

Orofacial pain unit Eastman Institute

Stockholm, 113 24, Sweden

Location

MeSH Terms

Conditions

Arthralgia

Interventions

MethylprednisoloneMethylprednisolone Acetate

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Göran Isacsson, DDS

    Orofacial pain unit, Västmanland Hospital Västerås

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2013

First Posted

November 26, 2013

Study Start

December 10, 2013

Primary Completion

March 15, 2017

Study Completion

March 15, 2017

Last Updated

May 19, 2017

Record last verified: 2017-05

Locations

SE(7)