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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
56
1 ml single dose Intra-articular Depo-Medrol 40 mg/ml
1 ml intra-articular placebo
Orofacial pain unit, Malar Hospital Eskilstuna
Eskilstuna, Södermanland County, Sweden
Dental specialist clinic Kaniken
Uppsala, Uppland, Sweden
Specialist clinic Stomatognathic physiology
Gothenburg, VastraGotaland, Sweden
Specialist center
Uddevalla, VastraGotaland, Sweden
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
Time frame: 4 weeks
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
Time frame: 4 weeks
Instrument measures
JFLS GCPS PHQ-9 PGIC
Time frame: 4 weeks
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?"
Time frame: 4 weeks
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Västerås, Västmanland County, Sweden
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Orofacial pain unit Eastman Institute
Stockholm, Sweden