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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

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.


Condition or disease Intervention/treatment Phase
Arthralgia TMJ Drug: Methylprednisolone Drug: Physiologic saline Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PhaseIV Study of Intra-articular Methylprednisolone in TMJ Arthralgia
Actual Study Start Date : December 10, 2013
Actual Primary Completion Date : March 15, 2017
Actual Study Completion Date : March 15, 2017


Arm Intervention/treatment
Placebo Comparator: Physiologic saline
Sodium chloride 9 mg/ml liquid for parental use
Drug: Methylprednisolone
1 ml single dose Intra-articular Depo-Medrol 40 mg/ml
Other Name: Depo-Medrol 40 mg/ml

Experimental: Methylprednisolone
Depo-Medrol 40 mg/ml, single dose, injection, intra-articular
Drug: Physiologic saline
1 ml intra-articular placebo
Other Name: Sham substance




Primary Outcome Measures :
  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 Outcome Measures :
  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?"




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01995019


Locations
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Sweden
Orofacial pain unit, Malar Hospital Eskilstuna
Eskilstuna, Södermanland, Sweden, 631 88
Dental specialist clinic Kaniken
Uppsala, Uppland, Sweden, 75148
Specialist clinic Stomatognathic physiology
Goteborg, VastraGotaland, Sweden, 40233
Specialist center
Uddevalla, VastraGotaland, Sweden, 45180
Orofacial pain unit, Västmanland Hospital Västerås
Västerås, Västmanland, Sweden, 72185
Orofacial pain unit Eastman Institute
Stockholm, Sweden, 113 24
Orofacial pain unit, Dental Specialist Education Center
Örebro, Sweden, 70111
Sponsors and Collaborators
Uppsala University
Investigators
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Principal Investigator: Göran Isacsson, DDS Orofacial pain unit, Västmanland Hospital Västerås
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Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT01995019    
Other Study ID Numbers: Artralgia1
2013-003365-34 ( EudraCT Number )
First Posted: November 26, 2013    Key Record Dates
Last Update Posted: May 19, 2017
Last Verified: May 2017
Keywords provided by Uppsala University:
Arthralgia
Temporomandibular joint
corticosteroids
injection
intra-articular
Additional relevant MeSH terms:
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Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents