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Study of intramuscular methylprednisolone acetate to treat pain in patients with hand osteoarthritis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with Hand Osteoarthritis, a condition that causes pain and stiffness in the hand joints. The research examines the effectiveness of methylprednisolone acetate, a medication that helps reduce inflammation and pain, when given as an injection into the muscle. The study compares two different doses of the medication (40mg and 120mg) against a placebo to determine how well it works for reducing hand pain.

The medication will be given as a single intramuscular injection, which means it is injected directly into a muscle. Some patients will receive the actual medication (Depo-Medrol), while others will receive sodium chloride solution as a placebo. The study will track how participants' hand pain changes over time, particularly during the first four weeks after the injection.

Throughout the study, which lasts 48 weeks, researchers will monitor various aspects of the participants' condition, including pain levels, hand function, and quality of life. They will also look at changes in joint structure and inflammation to better understand how the treatment works. This research aims to find out if this type of injection could be an effective treatment option for people with hand osteoarthritis who haven't found sufficient relief from other pain medications.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment visit
You will receive an intramuscular injection of either:
- 120mg methylprednisolone acetate, or
- 40mg methylprednisolone acetate, or
- placebo (salt solution)
The type of injection you receive will be randomly assigned
Step 2
4-week assessment
Your hand pain level will be measured using a digital scale from 0 to 100
Your ability to grip objects will be tested
You will complete questionnaires about your hand function and quality of life
Step 3
Follow-up period
Regular assessments will continue for 48 weeks
Your hand function and pain levels will be monitored
Images of your hand joints will be taken
Blood samples will be collected to measure inflammation markers
Step 4
Final assessment
A final evaluation of your hand condition will be performed
All measurements from the previous visits will be repeated
The total duration of your participation will be 48 weeks

Who can join the trial?

7 criteria

Must be diagnosed with interphalangeal hand osteoarthritis (joint inflammation in the fingers) confirmed by:
- Patient-reported symptoms including age and morning stiffness
- X-ray images taken within the last 6 months showing bone spurs and reduced joint space
- At least half of painful joints must show changes on X-rays
- Must be 45 years of age or older
- Must have hand pain rated higher than 40 on a 100-point pain scale, where 0 means no pain and 100 means worst possible pain
- Must have previously tried at least one standard pain medication (like topical or oral anti-inflammatory drugs) that did not provide enough pain relief
  - This does not include paracetamol (acetaminophen) treatment
  - Both men and women can participate

Who cannot join the trial?

15 criteria

Age below 18 or above 75 years
Previous hand surgery in the last 6 months
Active skin infection (presence of bacteria or fungi causing skin problems) in the hand area
Current treatment with oral corticosteroids (anti-inflammatory medications)
Known allergy to methylprednisolone or similar medications
Presence of other types of arthritis besides hand osteoarthritis
Pregnant or breastfeeding women
Uncontrolled diabetes (high blood sugar levels that are not well managed)
Active or recent hand injury
Current participation in other clinical trials
Severe mental health conditions that could affect participation
Unable to follow study procedures or complete questionnaires
History of chronic pain conditions affecting the hands
Immunosuppression (weakened immune system)
Recent steroid injections in the hands (within last 3 months)

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Verified sites

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Gelre Hospitals
Verified
Zutphen, The Netherlands
Leids Universitair Medisch Centrum (LUMC)
Responsive
Leiden, The Netherlands

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Investigated drugs

Methylprednisolone acetate is a corticosteroid medication that is injected into the muscle (intramuscular injection). It helps reduce inflammation and pain in patients with hand osteoarthritis. This medication works by suppressing the immune system's inflammatory response, which can help decrease pain, swelling, and stiffness in the joints of the hand.

What is already known about the treatment

Methylprednisolone - A potent corticosteroid medication administered through intramuscular injection, particularly used in treating inflammatory conditions such as hand osteoarthritis. This synthetic glucocorticoid works by suppressing the immune system and reducing inflammation, which helps alleviate pain and swelling in affected joints. The medication belongs to the class of corticosteroids and is typically administered in clinical settings under medical supervision, with dosages ranging from 40mg to 120mg depending on the severity of symptoms. Research has shown its effectiveness in providing rapid relief from acute inflammatory conditions, making it a valuable treatment option for patients with severe hand osteoarthritis who haven't responded adequately to conventional therapies.

Investigated diseases

Hand Osteoarthritis - A degenerative joint disease that affects the hands, particularly the joints in the fingers and thumb. The condition develops when the smooth cartilage that covers the ends of bones in the joints gradually wears away, leading to friction between bones. As the disease progresses, the joints become stiff, painful, and may develop bony growths called nodes. The condition can cause the fingers to become swollen and the grip strength to decrease. Hand osteoarthritis typically develops slowly over time and can affect one or both hands.