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

Primary Purpose

Arthralgia, TMJ

Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Methylprednisolone
Physiologic saline
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthralgia focused on measuring Arthralgia, Temporomandibular joint, corticosteroids, injection, intra-articular

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Orofacial pain unit, Malar Hospital Eskilstuna
  • Dental specialist clinic Kaniken
  • Specialist clinic Stomatognathic physiology
  • Specialist center
  • Orofacial pain unit, Västmanland Hospital Västerås
  • Orofacial pain unit Eastman Institute
  • Orofacial pain unit, Dental Specialist Education Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Physiologic saline

Methylprednisolone

Arm Description

Sodium chloride 9 mg/ml liquid for parental use

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Instrument measures
JFLS GCPS PHQ-9 PGIC
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?"

Full Information

First Posted
November 20, 2013
Last Updated
May 18, 2017
Sponsor
Uppsala University
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1. Study Identification

Unique Protocol Identification Number
NCT01995019
Brief Title
Arthralgia of the Temporomandibular Joint. Pain Relief Following One Intra-articular Injection of Methylprednisolone
Official Title
PhaseIV Study of Intra-articular Methylprednisolone in TMJ Arthralgia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
December 10, 2013 (Actual)
Primary Completion Date
March 15, 2017 (Actual)
Study Completion Date
March 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthralgia, TMJ
Keywords
Arthralgia, Temporomandibular joint, corticosteroids, injection, intra-articular

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physiologic saline
Arm Type
Placebo Comparator
Arm Description
Sodium chloride 9 mg/ml liquid for parental use
Arm Title
Methylprednisolone
Arm Type
Experimental
Arm Description
Depo-Medrol 40 mg/ml, single dose, injection, intra-articular
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Other Intervention Name(s)
Depo-Medrol 40 mg/ml
Intervention Description
1 ml single dose Intra-articular Depo-Medrol 40 mg/ml
Intervention Type
Drug
Intervention Name(s)
Physiologic saline
Other Intervention Name(s)
Sham substance
Intervention Description
1 ml intra-articular placebo
Primary Outcome Measure Information:
Title
VAS pain score change at maximal mouth opening
Description
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
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
VAS pain score change at jaw rest
Description
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
Time Frame
4 weeks
Title
Instrument measures
Description
JFLS GCPS PHQ-9 PGIC
Time Frame
4 weeks
Title
Adverse events
Description
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?"
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Göran Isacsson, DDS
Organizational Affiliation
Orofacial pain unit, Västmanland Hospital Västerås
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orofacial pain unit, Malar Hospital Eskilstuna
City
Eskilstuna
State/Province
Södermanland
ZIP/Postal Code
631 88
Country
Sweden
Facility Name
Dental specialist clinic Kaniken
City
Uppsala
State/Province
Uppland
ZIP/Postal Code
75148
Country
Sweden
Facility Name
Specialist clinic Stomatognathic physiology
City
Goteborg
State/Province
VastraGotaland
ZIP/Postal Code
40233
Country
Sweden
Facility Name
Specialist center
City
Uddevalla
State/Province
VastraGotaland
ZIP/Postal Code
45180
Country
Sweden
Facility Name
Orofacial pain unit, Västmanland Hospital Västerås
City
Västerås
State/Province
Västmanland
ZIP/Postal Code
72185
Country
Sweden
Facility Name
Orofacial pain unit Eastman Institute
City
Stockholm
ZIP/Postal Code
113 24
Country
Sweden
Facility Name
Orofacial pain unit, Dental Specialist Education Center
City
Örebro
ZIP/Postal Code
70111
Country
Sweden

12. IPD Sharing Statement

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

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