Actively Recruiting

Phase 4
Age: 50Years - 70Years
All Genders
NCT05761015

Helping Osteoarthritis Patients to Walk With NSAID

Led by University Hospital, Clermont-Ferrand · Updated on 2026-02-27

55

Participants Needed

1

Research Sites

224 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Clermont-Ferrand

Lead Sponsor

F

Fondation Apicil

Collaborating Sponsor

AI-Summary

What this Trial Is About

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. 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.

CONDITIONS

Official Title

Helping Osteoarthritis Patients to Walk With NSAID

Who Can Participate

Age: 50Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Uni- or bilateral idiopathic hip or knee osteoarthritis with Kellgren-Lawrence grade 2 or higher on recent X-ray
  • Osteoarthritis pain lasting at least 3 months
  • Walking pain intensity of at least 4 on a 10-point scale
  • Walking less than 3 times per week for at least 20 minutes or 1000 meters each time
  • Ability to understand and follow the study protocol and complete questionnaires
Not Eligible

You will not qualify if you...

  • Pregnancy or breastfeeding
  • Under legal protection
  • Body weight less than 40 kg or underweight
  • Body weight greater than 120 kg or obesity
  • Unable to walk or requiring support devices other than sticks, crutches, orthoses, or knee pads
  • Secondary osteoarthritis from other diseases (rheumatism, septic arthritis, osteonecrosis, hemochromatosis, gout, acromegaly)
  • Other general bone diseases (Paget, Reiter's disease)
  • Other significant painful diseases besides osteoarthritis (neuropathic pain, fibromyalgia)
  • Recent or planned surgery or interventions affecting osteoarthritis pain during the study
  • Recent start of new analgesic treatments including systemic steroids
  • Planned physiotherapy or cognitive behavioral therapy during the study
  • Current cancer
  • Immunosuppression or autoimmune disease
  • Use of topical or systemic NSAIDs during the study
  • Chronic strong opioid use
  • Insulin therapy
  • Any contraindication to NSAIDs or acetaminophen according to the French drug agency

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

CHU Clemront-Ferrand

Clermont-Ferrand, France

Actively Recruiting

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Research Team

L

Lise Laclautre

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Helping Osteoarthritis Patients to Walk With NSAID | DecenTrialz