Helping Osteoarthritis Patients to Walk With NSAID
Key facts
- Who runs it
- University Hospital, Clermont-Ferrand
- Where
- Clermont-Ferrand, FranceSee the site
- Trial code
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 55 people, planned
- Started
- 14 Dec 2023
- Expected to end
- Apr 2028
- Type of study
- Interventional
- Treatments tested
- therapeutic program including intermittent drug intake and multimodal rehabilitation program
- Record updated
- 27 February 2026
Who can take part
- Age
- 50 years to 70 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 23 criteriaShow less
Who can take part
- 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 4/10 on a numerical rating scale
- 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
Who cannot take part
- 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
- 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
- Concomitant topical or systemic NSAID treatment
- Concomitant insulin therapy
- Any absolute or relevant contraindication to NSAIDs or acetaminophen, according to the French drug agency
- Current cancer disease
- Autoimmune disease
- 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…)
- Planned intervention similar to those abovementioned, during the study period
- Immunosuppression
- Chronic strong opioid intake
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 50 and 70 years old?
Where in France
- CHU Clemront-FerrandClermont-Ferrand, FranceContact: Lise LaclautreTaking people
About the trial
What the trial wants to find out
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). NSAIDs are indeed known to act specifically on pain at movement, but their continuous intake would induce unacceptable side effects. To optimize the benefit/risk balance, the molecule to be chosen must fit to the patient's profile, and its intake should cover only the period of interest, i.e. planned walks. Our multimodal rehabilitation program will also include physical techniques such as appropriate footwear, a patient's education aiming at reducing fear/avoidance and spotting side effects of NSAIDs, and a prescription frame to avoid any overdosing.
Read full original descriptionShow less
This clinical study is a single-center, non-randomized, open label, one-arm trial, using drugs prescribed according to their label (i.e. osteoarthritis pain), pending a reinforced monitoring of side effects.
The primary endpoint is to evaluate efficacy and tolerance of a tailored and transient administration of NSAID within a rehabilitation walking program in patients with painful hip/knee osteoarthritis.
Secondary endpoints are to evaluate the adherence to the program and the factors influencing adherence; to identify the less well tolerated conditions of treatment (one condition being one molecule for one patient profile); to identify the factors of success among a set of baseline demographic, morphometric and psychometric variables; and to study the role of central sensitization (assessed by temporal summation) on the efficacy of treatment.
The group in the trial
- InterventionTreatment being tested
there is only one intervention arm and no control arm; the Bayesian analysis will be conducted under hypothetical estimates of superiority vs. control.
Treatment: therapeutic program including intermittent drug intake and multimodal rehabilitation program
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Rehabilitation Walking Program With the Help of a Transient Intake of Nonsteroidal Anti-inflammatory Drug for Patients With Painful Hip/Knee Osteoarthritis - A Pilot Cohort Study With Objectives of Short Walks in the Real Life.
- Fit questions
- Built from NCT05761015, who can take part
- Record updated
- 27 February 2026