Study on Metformin for Pain Relief in Patients with Hand Osteoarthritis

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What is this study about?

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.

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.

2 randomization

Participants are randomly assigned to receive either metformin or a placebo. The placebo is a tablet with no active ingredients.

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.

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.

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 Study?

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.
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.
- 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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Bispebjerg Hospital	Copenhagen	Denmark

Other Sites

Site Name	City	Country	Status
Region Midtjylland	Aarhus	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	01.02.2024

Trial locations

Investigated drugs:

Metformin Hydrochloride

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.

Investigated diseases:

Nodal osteoarthritis

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.

Trial ID:

2023-509181-38-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Metformin for Pain Relief in Patients with Hand Osteoarthritis

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