Actively Recruiting
The Efficacy and Safety of Intramuscular Methylprednisolone in Patients With Hand OsteoArthritis
Led by Sint Maartenskliniek · Updated on 2026-01-28
212
Participants Needed
1
Research Sites
157 weeks
Total Duration
On this page
Sponsors
S
Sint Maartenskliniek
Lead Sponsor
Z
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to determine the efficacy and safety of intramuscular methylprednisolone in patients with hand osteoarthritis. The main question it aims to answer is what the difference is in hand pain 4 weeks after the first injection with methylplrednisolone. This main goal will be assessed in the first 16 weeks, the RCT phase. Researchers will compare 120mg methylprednisolone with 40mg methylprednisolone and placebo to see if there is a difference in hand pain after 4 weeks. Participants will be asked to visit the hospital for: * injection of the study material * ultrasound assessment * physical examination like joint assessments and grip strenght * examination of blood * x-ray of the hand In phase 2, from week 16 to 48, an open label phase focusing on treatment strategy and safety. In this phase all participants may receive intramuscular methylprednisolone on demand at the dosage of 120mg only if they fulfil the following conditions: hand pain \> 30mm on a VAS (0-100mm) and a minimum of 16 weeks interval between two consecutive injections. Therefore, a maximum of two injections could be received during this period. Irrespective of that, all participants will be followed-up until week 48 when the end-of-study visit will take place.
CONDITIONS
Official Title
The Efficacy and Safety of Intramuscular Methylprednisolone in Patients With Hand OsteoArthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with interphalangeal hand osteoarthritis based on EULAR criteria and radiographs less than 6 months old
- Age 16 years or older
- Hand pain greater than 40mm on a 100mm visual analogue scale
- Previous failure of at least one conventional pain medication (excluding paracetamol)
You will not qualify if you...
- Chronic inflammatory rheumatic diseases
- Infectious diseases
- Known osteoporosis
- Known diabetes
- Previous diagnosis of fibromyalgia
- Known myasthenia gravis
- Previous surgical interventions on the hand
- Contraindications for methylprednisolone including current gastric or duodenal ulcers, current infections, liver cirrhosis, pregnancy or breastfeeding, known non-response or intolerance
- Use of interacting medications as per Dutch Medication Surveillance System
- Unable to read or write Dutch
- Neurological diagnoses including epilepsy or risk of psychiatric disorder
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sint Maartenskliniek
Ubbergen, Gelderland, Netherlands, 6574 NA
Actively Recruiting
Research Team
C
Calin Popa, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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