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New treatment option for Osteoarthritis, Knee
Official title Helping Osteoarthritis Patients to Walk With NSAID
ClinicalTrials.gov ID: NCT05761015
What this study is testing
What is therapeutic program including intermittent drug intake and multimodal rehabilitation program?
therapeutic program including intermittent drug intake and multimodal rehabilitation program is an investigational medicine, given as a twice-daily pill taken by mouth, being studied as a potential treatment for osteoarthritis, knee.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- There is a lack of effective analgesic treatments to help walking patients with painful hip/knee osteoarthritis. Our team therefore imagined a new strategy lying on a multimodal rehabilitation walking program with the help of a transient intake of nonsteroidal anti-inflammatory drug (NSAID).
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 70
You may be able to join if
- Uni- or bilateral hip or knee idiopathic osteoarthrosis (ACR criteria, Kellgren-Lawrence grade 2 or more on recent X-ray), responsible for pain since...
- Less than 3 relevant walks (at least 20 minutes or 1000 km) a week.
- Ability to understand and to follow the protocol, and to answer the questionnaires
You likely can't join if
- Pregnancy or breastfeeding
- Legal protection
- Body weight \< 40 kg or underweight
- Body weight \>120 kg or obesity
- Unability to walk, or unability to walk without support devices (sticks, crutches, orthoses and knee pads are allowed)
- Secondary osteoarthrosis (rheumatism, septic arthritis, recent osteonecrosis, hemochromatosis, gout, acromegalia…).
See the full eligibility criteria
- Uni- or bilateral hip or knee idiopathic osteoarthrosis (ACR criteria, Kellgren-Lawrence grade 2 or more on recent X-ray), responsible for pain since 3 at least months, and pain at walking which intensity is at least...
- Less than 3 relevant walks (at least 20 minutes or 1000 km) a week.
- Ability to understand and to follow the protocol, and to answer the questionnaires
- Pregnancy or breastfeeding
- Legal protection
- Body weight \< 40 kg or underweight
- Body weight \>120 kg or obesity
- Unability to walk, or unability to walk without support devices (sticks, crutches, orthoses and knee pads are allowed)
- Secondary osteoarthrosis (rheumatism, septic arthritis, recent osteonecrosis, hemochromatosis, gout, acromegalia…).
- Concomitant general bone disease (Paget, Reiter…).
- Concomitant and relevant painful disease else than due to osteoarthrosis (e.g. neuropathic pain, fibromyalgia…)
- Previous recent intervention (e.g. surgery, arthroscopy, joint infiltration) expected to relief osteoarthrosis pain throughout the study period.
- Planned intervention similar to those abovementioned, during the study period.
- Recent initiation of any new analgesic treatment (including systemic steroids).
- Planned initiation of any program expected to relief osteoarthrosis pain during the study period, such as physiotherapy, cognitive behavioral therapy…).
- Planned major surgery during the study period.
- Current cancer disease.
- Immunosuppression.
- Autoimmune disease.
- Concomitant topical or systemic NSAID treatment.
- Chronic strong opioid intake.
- Concomitant insulin therapy.
- Any absolute or relevant contraindication to NSAIDs or acetaminophen, according to the French drug agency
The study team makes the final eligibility decision.
Where it's taking place
- Clermont-Ferrand, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Clermont-Ferrand, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.