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Helping Osteoarthritis Patients to Walk With NSAID

Study acronym: PERIPATEI
StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Notable Primary completion date: Jul 1, 2025 to Apr 2028
    • Study completion date: Nov 1, 2025 to Apr 2028
    • Collaborators revised (4)
    v5
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 1, 2023 to Dec 14, 2023
    • Site details revised
    v4
  3. Notable Start date: Mar 1, 2023 to Dec 1, 2023
    • Study title shortened, about 1 word
    v3
  4. Minor Re-verified, no change to tracked fieldsv2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05761015
Lead Sponsor University Hospital, Clermont-Ferrand
Collaborators: Fondation Apicil, SARL BOUCHARENC, Saint-Chély d'Apcher, France, Université d'Auvergne, NEURO-DOL (UMR 1107 INSERM / UCA)
Conditions
(from sponsor)
Osteoarthritis, Knee, Osteoarthritis, Hip, Chronic Pain
Related terms Chronic Pain, Osteoarthritis, Hip, Osteoarthritis, Knee
Enrollment 55 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov