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Study on Pain Relief Using Botulinum Toxin in Thumb Osteoarthritis for Patients with Carpometacarpal Joint Issues

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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 treatment for osteoarthritis of the thumb, specifically in the joint at the base of the thumb known as the carpometacarpal joint. The treatment being tested is an injection of botulinum toxin, which is a substance that can help reduce muscle activity and pain. The specific product used in this study is called XEOMIN, which contains a type of botulinum toxin known as Clostridium botulinum neurotoxin type A. The study will compare the effects of this treatment to a placebo to see if it is more effective in reducing pain.

The purpose of the study is to determine if the botulinum toxin injection can improve pain in people with thumb osteoarthritis over a period of three months. Participants in the study will receive an injection directly into the affected joint. The study will monitor changes in pain levels using a simple scale where participants rate their pain from 0 (no pain) to 10 (worst imaginable pain). This will help researchers understand how effective the treatment is in managing pain associated with this type of osteoarthritis.

Throughout the study, participants will be asked to report their pain levels at different times to track any improvements. The goal is to see if the botulinum toxin injection provides better pain relief compared to the placebo. This research could lead to new ways of managing pain for those suffering from osteoarthritis of the thumb, potentially improving their quality of life.

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
Initial visit
Upon joining the study, you will attend an initial visit. During this visit, your eligibility will be confirmed based on specific criteria, such as age and the severity of your thumb osteoarthritis.
You will undergo a physical examination and provide a medical history. An X-ray of your wrist will be reviewed to assess the condition of your thumb joint.
Step 2
Baseline assessment
A baseline assessment will be conducted to measure your current level of pain using a tool called the Visual Analogue Scale (VAS). This scale ranges from 0 to 10, where 0 means no pain and 10 means the worst pain imaginable.
This assessment helps to establish a starting point for evaluating changes in your pain levels throughout the study.
Step 3
Treatment administration
You will receive an intra-articular injection in the thumb joint. This means the injection will be administered directly into the joint space.
The injection will contain either the active substance, botulinum toxin type A, or a placebo. The purpose is to compare the effects of the active treatment against a non-active substance.
Step 4
Follow-up visits
You will attend follow-up visits at regular intervals to monitor your progress and any changes in your pain levels.
During these visits, the Visual Analogue Scale (VAS) will be used again to measure your pain. This will help determine the effectiveness of the treatment over time.
Step 5
Final assessment
At the end of the study period, a final assessment will be conducted. This will include a comprehensive evaluation of your pain levels and any other relevant health changes.
The results will be compared to the baseline assessment to determine the overall impact of the treatment on your thumb osteoarthritis.

Who can join the trial?

5 criteria

Patient must be over 18 years old.
Patient must have a condition called rhizarthrosis, which is a type of osteoarthritis affecting the base of the thumb. This should be confirmed by a doctor and an X-ray showing at least two of the following: bone spurs (osteophytes), narrowing of the joint space, hardening of the bone under the cartilage (subchondral sclerosis), or small cysts in the bone (geodes).
Patient must have had an X-ray of the wrist to assess the severity of the condition. This X-ray should include different views: front, side, and a special view called Kapandji incidence.
Patient must have a pain level greater than 4 on a scale called the Visual Analog Scale (VAS), which is a way to measure pain intensity.
Patient must have tried and not found relief from standard treatments, including level 1 and 2 pain relievers (analgesics), anti-inflammatory drugs, and supportive devices like braces or splints.

Who cannot join the trial?

9 criteria

Patients with any other type of arthritis in the hand, except for **osteoarthritis of the first carpometacarpal joint**.
Patients who have had a **botulinum toxin** injection in the hand in the last 6 months. Botulinum toxin is a substance used to reduce muscle activity.
Patients with a known allergy to **botulinum toxin**.
Patients who are pregnant or breastfeeding.
Patients with a history of **neuromuscular disorders**. These are conditions that affect the nerves and muscles.
Patients currently participating in another clinical trial.
Patients who have had surgery on the affected joint in the last 6 months.
Patients with severe **joint deformity** in the affected area. Joint deformity means the joint is not in its normal shape.
Patients with **severe pain** that cannot be managed with standard pain relief methods.

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Centre Hospitalier Universitaire De Nice
Nice, France

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Investigated drugs

Botulinum Toxin is a medication used in this clinical trial to help reduce pain in the thumb joint caused by osteoarthritis. It is injected directly into the joint area. The goal of using botulinum toxin is to see if it can provide better pain relief compared to not using it. This medication works by blocking certain nerve signals that cause muscles to contract, which may help reduce pain and improve movement in the affected joint.

Clostridium Botulinum Neurotoxin Type A (150Kd), Free Of Complexing Proteins

What is already known about the treatment

Botulinum toxin – This medication is administered through an injection directly into the joint, specifically targeting the thumb's carpometacarpal joint affected by osteoarthritis. Currently, botulinum toxin is being studied in clinical trials to assess its effectiveness in reducing pain associated with this type of arthritis. The main therapeutic use being investigated is pain relief in osteoarthritis of the thumb joint. At the molecular level, botulinum toxin works by blocking nerve signals that cause muscle contractions, which can help reduce pain and improve joint function. It is classified pharmacologically as a neurotoxin.

Investigated diseases

Osteoarthritis of the first carpometacarpal joint – This condition affects the joint at the base of the thumb, where the thumb meets the wrist. It is characterized by the degeneration of cartilage, leading to pain and stiffness in the joint. Over time, the joint may become swollen and lose its normal shape, causing difficulty in thumb movement. As the disease progresses, individuals may experience reduced grip strength and difficulty performing tasks that require pinching or grasping. The condition is often associated with repetitive use or stress on the joint. It is a common form of arthritis, particularly in older adults.