Study on Walking Rehabilitation for Hip or Knee Osteoarthritis Using Ketoprofen and Drug Combination for Patients with Osteoarthritis

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What is this study about?

This clinical trial focuses on patients with osteoarthritis of the hip or knee, a condition that causes joint pain and stiffness. The study aims to evaluate the effectiveness and safety of using a non-steroidal anti-inflammatory drug (NSAID) as part of a walking rehabilitation program. The medications being studied include ketoprofen (marketed as PROFENID), paracetamol (also known as DOLIPRANE), niflumic acid (NIFLURIL), lansoprazole (LANSOPRAZOLE MYLAN PHARMA), ibuprofen (IBUPROFENE ARROW), and diclofenac epolamine (FLECTOR). These medications are taken orally in various forms such as capsules, tablets, and solutions.

The purpose of the study is to determine if taking an NSAID can help improve walking ability in patients with osteoarthritis. Participants will be involved in a walking rehabilitation program, where they will take one of the study medications or a placebo. The study will monitor the participants’ progress over a period of time to see if there is an improvement in their ability to walk and manage pain. The goal is to see if there is at least a 30% increase in the number of walking activities compared to the start of the study.

Participants will be asked to take the medication as directed and report any changes in their symptoms or any side effects they experience. The study will last for up to 12 weeks, during which time participants will be regularly assessed to track their progress. The findings from this study could help improve treatment options for people with osteoarthritis of the hip or knee, potentially leading to better management of pain and improved mobility.

1 initial assessment

Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes verifying the diagnosis of osteoarthritis of the hip or knee through medical history and x-ray results.

Participants must be between 50 to 70 years old and experience joint pain rated at least 4 out of 10, with limited walking ability.

2 baseline observation

A baseline observation period will be established to record the current level of physical activity. This involves tracking the number of significant walking trips, defined as walking for at least 20 minutes or 1000 meters, which should be less than three times per week.

3 medication administration

Participants will receive a one-off anti-inflammatory treatment to assist with the walking rehabilitation program. The medications used may include ketoprofen, paracetamol, niflumic acid, lansoprazole, ibuprofen, or diclofenac epolamine, all administered orally.

The specific medication, dosage, and frequency will be determined by the study protocol and communicated to each participant individually.

4 walking rehabilitation program

Participants will engage in a structured walking rehabilitation program. The goal is to increase the monthly number of target movements by at least 30% compared to the baseline observation month.

The program will include short walking objectives tailored to each participant’s capabilities and progress.

5 monitoring and evaluation

Throughout the trial, participants will be monitored for the efficacy and tolerance of the treatment. Regular evaluations will be conducted to assess progress and any potential side effects.

The primary endpoint is the success of the therapeutic program, defined by the increase in walking activity without discontinuation of the treatment due to intolerance.

6 completion of trial

Upon completion of the trial, participants will undergo a final assessment to evaluate the overall outcomes of the walking rehabilitation program and the impact of the anti-inflammatory treatment.

Feedback and results will be shared with participants, contributing to the study’s findings on managing osteoarthritis of the hip or knee.

Who Can Join the Study?

Patient must be a man or woman aged between 50 and 70 years old.
Patient must have idiopathic osteoarthritis of the hip or knee. This means the cause of the arthritis is unknown.
The diagnosis must be confirmed by specific criteria, including:
- Joint pain felt for at least half the time during the last 3 months.
- Morning stiffness lasting less than 30 minutes or joint crackling sounds.
- X-ray showing a Kellgren and Lawrence stage of 2 or higher. This is a way to measure the severity of osteoarthritis.
Patient must experience walking pain rated at least 4 on a scale from 0 (no pain) to 10 (worst imaginable pain), which limits their ability to walk.
Patient must walk less than 3 significant trips per week, where a significant trip is walking for at least 20 minutes or 1000 meters.
Patient must be able to follow the study requirements and agree to participate by providing informed consent.
Patient must understand and be able to write in French fluently.
Patient must be covered by a Social Security scheme.

Who Cannot Join the Study?

Patients who have a different type of arthritis than idiopathic osteoarthritis of the hip or knee. Idiopathic means the cause of the condition is unknown.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.
Patients who cannot safely take non-steroidal anti-inflammatory drugs (NSAIDs). These are medications often used to reduce pain and inflammation.
Patients who are not participating in a walking rehabilitation program.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
CHU Gabriel-Montpied	Clermont Ferrand	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	14.12.2023

Trial locations

Investigated drugs:

Non-Steroidal Anti-Inflammatory Drug (NSAID): This medication is used to help reduce inflammation and pain in the body. In this trial, it is given as a one-time treatment to help patients with osteoarthritis of the hip or knee. The goal is to see if taking this medication can make it easier for patients to participate in a walking rehabilitation program. By reducing pain and swelling, the medication may help improve the ability to walk and perform daily activities.

Idiopathic Osteoarthritis of the Hip or Knee – Idiopathic osteoarthritis of the hip or knee is a degenerative joint disease characterized by the breakdown of cartilage in the hip or knee joints. This condition leads to pain, stiffness, and reduced mobility in the affected joint. As the disease progresses, the cartilage wears away, causing bones to rub against each other, which can result in swelling and further pain. Over time, the joint may become deformed, and bone spurs may develop. The progression of the disease can vary, with some individuals experiencing a slow decline in joint function, while others may have more rapid deterioration. The exact cause of idiopathic osteoarthritis is unknown, but it is often associated with aging and wear and tear on the joints.

Trial ID:

2022-502018-10-00

Protocol code:

RBHP 2022 DUALE

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Walking Rehabilitation for Hip or Knee Osteoarthritis Using Ketoprofen and Drug Combination for Patients with Osteoarthritis

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