RecruitingNAINTERVENTIONAL

Knee Osteoarthritis and Spa Therapy

This study is investigating an 18-day spa treatment program for people living with knee osteoarthritis. The main goal is to find out if this treatment, which uses natural mineral waters in Santenay, France, can help reduce common problems like pain and stiffness in the knee. We also want to see if it makes daily activities easier and generally improves how people feel about their lives. We'll compare people taking part in this spa program to a group from a previous study who received standard care, like pain relief and exercise advice. All participants in this new study will receive the 18-day spa treatment and have check-ups when they start and six months later. This research aims to understand if spa therapy could be a valuable option for managing knee osteoarthritis.

At a glance

Status

Recruiting

Phase

Sponsor

CEN Biotech

Enrolment target

Start

14 Oct 2024

Estimated completion

31 Dec 2026

Knee Osteoarthritis Knee Osteoarthritis (OA)

What is this study about?

If you live with knee osteoarthritis, you know how painful and stiff your knees can get, making everyday tasks difficult. This study is designed to explore whether a specific 18-day spa treatment program, known as balneotherapy, can make a real difference. Balneotherapy involves various therapies using natural mineral water from Santenay in France, and it's thought to help with conditions like arthritis.

The main purpose of this research is to see if this spa program can ease your knee pain, reduce stiffness, and generally help you move around more easily. Ultimately, the researchers want to understand if this kind of treatment can improve your overall quality of life when you have knee osteoarthritis. This isn't just about feeling a bit better; it's about seeing if the changes are significant enough to really help manage your condition.

To figure this out, we'll be looking at people who participate in the spa program and comparing their progress to information gathered from a previous study. That older study involved people with knee osteoarthritis who received standard care, such as painkillers and advice on exercises. By comparing these two groups, researchers hope to get a clearer picture of how effective the spa treatment is compared to what's already available.

Key takeaways

This study evaluates an 18-day spa treatment for knee osteoarthritis.
It aims to reduce pain and stiffness, and improve quality of life.
The treatment uses natural mineral water in Santenay, France.
You will have check-ups at the start, 3 months, and 6 months.
Compares spa treatment to standard care for knee problems.
Open to individuals aged 50-80 with certain osteoarthritis types.

Who may be eligible?

This study is looking for people aged 50 to 80, both men and women, who have knee osteoarthritis. To be considered, an X-ray of your knee taken in the last three years should show signs of osteoarthritis (stages 2 to 4). Your knee pain and stiffness should also affect your daily activities to a certain degree. You'll need to be willing to actually go through with the 18-day spa treatment in Santenay, France, and have valid health insurance.

There are some reasons why you might not be able to join. For example, if you have other serious health problems like certain heart, liver, or kidney conditions, or an active infection or cancer. You also can't take part if you have other types of chronic pain such as rheumatoid arthritis or fibromyalgia, as this study focuses specifically on knee osteoarthritis.

Also, if you've had a spa treatment for anything in the past six months, or injections in your knee (steroids in the last 3 months, hyaluronic acid in the last 6 months), you won't be able to join. If you're planning knee surgery soon, live too far from Santenay, or can't commit to the study visits, you won't be eligible. Women who could become pregnant must be using effective birth control consistently throughout the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 50 and 80 years old?
Do you have knee osteoarthritis confirmed by an X-ray in the last 3 years (stages 2-4)?
Are your knee pain and stiffness affecting your daily activities?
Are you prepared to travel to Santenay, France for an 18-day spa treatment?
Have you not had an intra-articular steroid injection in your knee in the last 3 months, or hyaluronic acid in the last 6 months?
Are you able to read and understand French?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive an 18-day course of balneotherapy treatment. This involves various therapies using natural mineral water from Santenay. Before starting the treatment, and again six months after it begins, you'll have a medical check-up with a doctor involved in the study. There will also be a shorter check-in by phone or online three months after starting.

During these visits, the doctor will collect some information about your knee condition, or you might fill out some questionnaires yourself to describe your pain and how easily you can move. You'll also be given advice on exercises that are suitable for people with knee osteoarthritis, similar to the advice given in previous studies. Your weight and your ability to be physically active will also be monitored throughout the study. The total duration of your participation, from your first visit to your final follow-up, will be about seven months.

Potential risks and benefits

Participating in this study might offer potential benefits, such as a reduction in your knee pain and stiffness, making it easier for you to move and improving your overall quality of life through the spa treatment. However, as with any medical treatment or study, there could be some risks. These are generally related to the spa treatments themselves, such as potential reactions to the water or therapies, although serious risks are uncommon and contraindications are carefully checked. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Valvital - Thermes de Santenay
Verified postcode
Santenay, France· Recruiting

Common questions

What exactly is 'balneotherapy'?

Balneotherapy is a type of therapy that uses natural mineral water, often from springs, for bathing and other treatments to help various health conditions, in this case, knee osteoarthritis.

Where does this spa treatment take place?

The spa treatment program will take place in Santenay, a town in the Burgundy region of France.

Will I have to pay for the spa treatment?

The study description indicates that participants will receive the 18-day balneotherapy program. As typical for clinical trials, treatment related to the study is usually covered for participants, but you should confirm this with the study team.

How long will I be involved in the study?

From your first visit before the spa treatment to your final check-up, you will be involved for about seven months.

What if I can't speak French?

The study states that you must be able to read or understand French, so this specific study might not be suitable if you only speak English.

How to find out more

Christine JUHEL, Ph.D

christine.juhel@groupecen.com +33380680511 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.