methylprednisolone
Drug1 ml single dose Intra-articular Depo-Medrol 40 mg/ml
Other names: Depo-Medrol 40 mg/ml
NCT Number: NCT01995019
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Orofacial pain unit, Malar Hospital Eskilstuna, Eskilstuna, Södermanland County, Sweden
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1 ml single dose Intra-articular Depo-Medrol 40 mg/ml
Other names: Depo-Medrol 40 mg/ml
1 ml intra-articular placebo
Other names: Sham substance
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
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
Time frame: 4 weeks
JFLS GCPS PHQ-9 PGIC
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?"
Uppsala University
Other
PhaseIV Study of Intra-articular Methylprednisolone in TMJ Arthralgia
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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