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Study on Metformin for Pain Relief 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 clinical trial is focused on studying the effects of a medication called Metformin on patients with hand osteoarthritis. Osteoarthritis is a condition that causes pain and stiffness in the joints, and in this study, the focus is on the joints of the hand. Metformin is a medication commonly used to treat diabetes, but researchers are exploring its potential benefits for reducing pain in hand osteoarthritis.

The purpose of the study is to compare the effects of Metformin with a placebo, which is a substance that looks like the medication but contains no active ingredients. Participants in the study will be randomly assigned to receive either Metformin or the placebo. The study will last for 16 weeks, during which participants will take the medication or placebo and have their finger joint pain assessed. The main goal is to see if Metformin can help reduce pain in the hand joints compared to the placebo.

Throughout the study, participants will have their pain levels measured using a simple scale to track any changes. This will help researchers understand if Metformin can be an effective treatment for hand osteoarthritis. The study aims to provide valuable information on whether Metformin can offer relief for those suffering from this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, a diagnosis of hand osteoarthritis is confirmed by a medical doctor. The diagnosis must meet specific criteria, including hand pain, aching, or stiffness on most days in the previous four weeks, and at least three additional features such as hard tissue enlargement or joint deformity.
Step 2
Randomization
Participants are randomly assigned to receive either metformin or a placebo. The placebo is a tablet with no active ingredients.
Step 3
Treatment phase
Participants take the assigned medication orally. If assigned to the metformin group, the dosage is 500 mg in the form of film-coated tablets.
The treatment lasts for 16 weeks, during which participants are required to take the medication as instructed.
Step 4
Assessment of pain
The main objective is to assess the change in finger joint pain of the target hand. This is measured using a visual analogue scale (VAS) after 16 weeks of treatment.
Step 5
End of treatment evaluation
At the end of the 16-week treatment period, participants attend a visit in week 17 to evaluate the change in finger joint pain from the baseline.

Who can join the trial?

9 criteria

The participant must be at least 18 years old.
The participant must have a diagnosis of hand osteoarthritis (OA). This will be confirmed by a doctor at the start of the study.
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The participant must meet the American College of Rheumatology (ACR) criteria for hand OA, which includes:
- Hand pain, aching, or stiffness on most days in the past 4 weeks.
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  At least 3 of the following features:
  - Hard tissue enlargement in at least 2 of the 10 selected joints. These joints are specific finger joints.
  - Hard tissue enlargement in at least 2 of the 10 DIP joints (these are joints near the tips of the fingers).
  - Fewer than 3 swollen metacarpophalangeal (MCP) joints (these are the knuckle joints).
  - Deformity in at least 1 of the 10 selected joints.
  - The participant must have an average finger pain score of 4 or higher on a scale from 0 to 10 over the past 30 days, where 10 is the worst pain.
  - The participant must be metformin naive, meaning they have not taken metformin before.

Who cannot join the trial?

4 criteria

Patients who are not experiencing pain in their finger joints.
Individuals who are not diagnosed with **Osteoarthritis**, which is a condition that affects the joints, causing pain and stiffness.
People who are not within the specified age range for the study.
Participants who are part of a vulnerable population, meaning they might need special protection or care.

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Verified sites

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Verified
Bispebjerg Hospital
Copenhagen, Denmark
Responsive
Region Midtjylland
Aarhus, Denmark

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Investigated drugs

Metformin is a medication commonly used to treat type 2 diabetes. In this clinical trial, it is being tested to see if it can help reduce finger joint pain in patients with hand osteoarthritis. The trial aims to measure the change in pain levels after 16 weeks of treatment with metformin.

Metformin Hydrochloride

What is already known about the treatment

Metformin – Metformin is typically administered orally in tablet form. It is widely recognized in medical literature as a treatment for type 2 diabetes, but it is currently being explored for its potential benefits in treating osteoarthritis, particularly in reducing finger joint pain. The main therapeutic indication in this context is osteoarthritis. Metformin works by decreasing glucose production in the liver and improving insulin sensitivity, which may have anti-inflammatory effects that could benefit joint health. It is classified as a biguanide in pharmacology.

Investigated diseases

Osteoarthritis – Osteoarthritis is a common joint disorder that primarily affects the cartilage, which is the protective tissue at the ends of bones. As the cartilage wears down over time, it can lead to pain, swelling, and reduced motion in the affected joints. The disease often progresses slowly, with symptoms worsening over the years. It most commonly affects joints in the hands, knees, hips, and spine. People with osteoarthritis may experience stiffness, especially in the morning or after resting. The condition can lead to the development of bone spurs and a grating sensation during joint movement.