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
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|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
Placebo Comparator: Physiologic saline
Sodium chloride 9 mg/ml liquid for parental use
1 ml single dose Intra-articular Depo-Medrol 40 mg/ml
Other Name: Depo-Medrol 40 mg/ml
Depo-Medrol 40 mg/ml, single dose, injection, intra-articular
Drug: Physiologic saline
1 ml intra-articular placebo
Other Name: Sham substance
- 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
- 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?"
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
|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|
|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|
|Principal Investigator:||Göran Isacsson, DDS||Orofacial pain unit, Västmanland Hospital Västerås|