Intramuscular methylprednisolone for relieving hand osteoarthritis pain
The Efficacy and Safety of Intramuscular Methylprednisolone in Patients With Hand OsteoArthritis - the IMHOA Trial
This trial will test whether one or two doses of intramuscular methylprednisolone (120 mg or 40 mg) reduce hand pain more than a placebo in people with hand osteoarthritis.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 212 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Sint Maartenskliniek Academic / other |
| Locations | 1 site (Ubbergen, Gelderland) |
| Trial ID | NCT07371572 on ClinicalTrials.gov |
What this trial studies
This Phase 3 randomized, placebo-controlled trial compares a single intramuscular injection of 120 mg methylprednisolone, 40 mg methylprednisolone, or placebo with the primary outcome of change in hand pain at 4 weeks. The randomized controlled phase runs for 16 weeks with scheduled hospital visits for injection, ultrasound, joint examinations, grip strength testing, blood tests, and hand x-rays. From week 16 to 48 participants enter an open-label phase in which they may receive 120 mg methylprednisolone on demand if their hand pain exceeds 30 mm on a 100 mm visual analogue scale. Safety and treatment strategy outcomes will be followed throughout the 48-week period.
Who should consider this trial
Good fit: People aged 16 or older with interphalangeal hand osteoarthritis by EULAR criteria, recent radiographs (≤6 months) showing osteophytes or joint space narrowing concordant with symptoms, hand pain greater than 40 mm on a 100 mm VAS, and prior insufficient response to at least one conventional pain medication are the intended participants.
Not a fit: Patients with excluded comorbidities (chronic inflammatory rheumatic disease, infection, known osteoporosis, diabetes, fibromyalgia, myasthenia gravis), prior hand surgery, those with milder pain, or those who meet other exclusion criteria are unlikely to benefit or be eligible for this trial.
Why it matters
Potential benefit: If effective, intramuscular methylprednisolone could provide short-term reduction in hand pain and improve function for people with hand osteoarthritis.
How similar studies have performed: Local steroid injections for osteoarthritis have produced short-term pain relief in other studies, but the use of intramuscular methylprednisolone for hand osteoarthritis is less well studied at this scale.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with interphalangeal hand OA (according to the EULAR classification criteria 2023) based on patient report (age, morning stiffness) and radiographs of ≤6 months old (osteophytes, JSN (joint space narrowing) and symptom-structure concordance (present if majority (≥50%) of the symptomatic joints demonstrate radiographic findings)). * Age ≥ 16 years * Have hand pain \>40mm on a 100mm visual analogue scale (VAS) * Have previously experienced failure of at least one conventional type of pain medication, (self-reported of insufficient effect from topical or oral NSAID, etc. with exclusion of paracetamol) Exclusion Criteria: * Comorbidity * Chronic inflammatory (rheumatic) diseases * Infectious diseases * Known Osteoporosis * Known Diabetes * Previous diagnosis of fibromyalgia * Known myasthenia gravis * Previous surgical interventions on the hand (e.g. carpal tunnel syndrome, etc.) * Use of other Medication: In order to maximize the generalizability of the study interactions between methylprednisolone and co-medication is only prohibited when the Dutch Medication Surveillance System (Z-index) gives a signal for this interaction. * Patients with a contraindication for MP * Current Gastric and duodenal ulcers * Current infections * Liver cirrhosis * Pregnant or breastfeeding * Known non-response or intolerance for MP * Not able to read or write the Dutch language * Neurological diagnosis * Epilepsy * Risk of psychiatric disorder
Where this trial is running
Ubbergen, Gelderland
- Sint Maartenskliniek — Ubbergen, Gelderland, Netherlands (Recruiting)
Study contacts
- Study coordinator: Calin Popa, Dr.
- Email: c.popa@maartenskliniek.nl
- Phone: 0243659276
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.