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Study on Painful Thumb Osteoarthritis: Comparing Triamcinolone Acetonide, Sodium Chloride, and Occupational Therapy for Patients with Inflammatory Thumb Joint Pain

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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 treatments for osteoarthritis in the base joint of the thumb, known as the first carpometacarpal joint. Osteoarthritis is a condition that causes pain and swelling in the joints. The study will explore the effectiveness of different treatments, including an injection of a medication called Kenacort-T, which contains the active ingredient triamcinolone acetonide, and a saline solution, which is a mixture of water and sodium chloride. Additionally, the study will evaluate the benefits of occupational therapy, which involves exercises and techniques to improve hand function.

The purpose of the study is to determine if the steroid injections are more effective than saline injections after four weeks and to compare the results of all three treatments after twelve weeks. Participants will receive one of these treatments through an injection directly into the affected joint. The study will monitor changes in pain and joint function over time, using simple scales to measure pain levels and other symptoms.

Participants will be observed over a period of several weeks to assess how their symptoms change with each treatment. The study aims to provide valuable information on which treatment might offer the best relief for those suffering from painful thumb base osteoarthritis. This information could help guide future treatment options for patients with this condition.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the trial, an initial assessment is conducted to confirm eligibility. This includes verifying age between 40-85 years, confirming osteoarthritis in the first carpometacarpal joint through radiographs or ultrasound, and assessing pain levels in the joint.
Step 2
Treatment allocation
Participants are randomly assigned to one of three treatment groups: intraarticular corticosteroid injections, saline injections, or a multimodal occupational therapy intervention.
Step 3
Treatment administration
For those receiving injections, the treatment involves an intra-articular injection into the joint. The corticosteroid used is triamcinolone acetonide (Kenacort-T 40 mg/ml), and the saline solution is sodium chloride (Natriumklorid Fresenius Kabi 9 mg/ml).
Step 4
Follow-up assessments
Follow-up assessments occur at various intervals: 4 weeks, 12 weeks, 24 weeks, and 104 weeks. These assessments measure changes in pain, joint function, and overall disease activity using a Numeric Rating Scale (NRS) and other evaluation tools.
Step 5
Primary outcome evaluation
The primary outcome is evaluated by assessing changes in thumb base joint pain during activities over the last 24 hours, measured at 4 weeks and 12 weeks.
Step 6
Secondary outcome evaluation
Secondary outcomes include changes in pain in finger joints, grip strength, use of pain relief medications, and patient satisfaction. These are assessed at multiple time points throughout the trial.
Step 7
Completion of trial
The trial is estimated to conclude by October 2027. Final assessments will be conducted to evaluate long-term effects and any adverse events experienced during the trial.

Who can join the trial?

5 criteria

Men and women between 40-85 years of age
Have **osteoarthritis** in the target CMC-1 joint, which is confirmed by X-rays or an ultrasound. **Osteoarthritis** is a condition that affects the joints, causing pain and stiffness.
Have **inflammation** in the target CMC-1 joint, confirmed by an ultrasound showing a grey scale synovitis grade of 1-3. **Inflammation** is the body's response to injury or irritation, often causing redness, warmth, swelling, and pain.
Experience pain in the target CMC-1 joint with a score of at least 3 on a 0-10 **Numeric Rating Scale (NRS)** at rest or during activities, both at pre-screening and screening. The **Numeric Rating Scale** is a way to measure pain intensity, where 0 means no pain and 10 means the worst possible pain.
Assessed as eligible for the proposed use of **Kenacort-T**, a medication used in the treatment.

Who cannot join the trial?

10 criteria

Patients who have had surgery on the affected joint in the past 6 months cannot participate.
Patients with an infection in the affected joint are not eligible.
Patients who have received a corticosteroid injection in the affected joint within the last 3 months are excluded.
Patients with a known allergy to corticosteroids or any component of the injection cannot join the study.
Patients with a history of severe allergic reactions, known as anaphylaxis, to any medication are not eligible. Anaphylaxis is a serious and rapid allergic reaction that can be life-threatening.
Patients who are currently participating in another clinical trial are not allowed to join this study.
Patients with a condition that, in the opinion of the investigator, would interfere with the study results or the patient's safety are excluded.
Pregnant or breastfeeding women cannot participate in the study.
Patients with uncontrolled diabetes or other uncontrolled medical conditions are not eligible. Uncontrolled means the condition is not being managed well with treatment.
Patients with a history of drug or alcohol abuse in the past year are excluded.

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Helse Stavanger HF
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Stavanger, Norway

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Investigated drugs

Corticosteroid Injections
are used in this trial to reduce inflammation and pain in the joint. They are injected directly into the affected area to provide relief from symptoms associated with osteoarthritis.
Saline Injections
are used as a comparison treatment in this trial. They involve injecting a saltwater solution into the joint, which does not have active therapeutic effects but helps to evaluate the effectiveness of the corticosteroid injections.
Occupational Therapy Intervention
is a non-drug treatment included in the trial. It involves various techniques and exercises designed to improve hand function and reduce pain in patients with osteoarthritis of the thumb joint.

What is already known about the treatment

Corticosteroid Injections
These are administered directly into the joint through an injection. Currently, corticosteroid injections are widely used in medicine for their anti-inflammatory properties and are well-documented in medical literature. They are primarily indicated for reducing pain and inflammation in conditions like osteoarthritis, particularly in the first carpometacarpal joint. At the molecular level, corticosteroids work by suppressing the immune response and reducing the production of inflammatory chemicals. They are classified as anti-inflammatory agents.
Saline Injections
These are also administered directly into the joint through an injection. Saline injections are often used as a placebo in clinical trials and are well-documented in medical literature for this purpose. They are used in this trial to compare the efficacy of other treatments for osteoarthritis in the first carpometacarpal joint. Saline itself does not have a therapeutic effect but is used to provide a baseline for comparison. It is classified as a non-therapeutic agent in this context.

Investigated diseases

Osteoarthritis in the first carpometacarpal joint – This condition involves the degeneration of cartilage in the joint at the base of the thumb, leading to pain and stiffness. It is a common form of arthritis that affects the hands, particularly in older adults. As the cartilage wears down, bones may rub against each other, causing discomfort and reduced range of motion. Over time, the joint may become swollen and tender, and activities that require thumb movement can become challenging. The progression of the disease can lead to changes in joint structure, such as the development of bone spurs. This condition can significantly impact hand function and daily activities.