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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.

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU Clemront-Ferrand
RECRUITING
Clermont-ferrand
Contact Information
Primary
Lise Laclautre
promo_interne_drci@chu-clermontferrand.fr
04 73 75 11 95
Time Frame
Start Date: 2023-12-14
Estimated Completion Date: 2028-04
Participants
Target number of participants: 55
Treatments
Experimental: Intervention
there is only one intervention arm and no control arm; the Bayesian analysis will be conducted under hypothetical estimates of superiority vs. control.
Related Therapeutic Areas
Sponsors
Collaborators: Plateforme d'Investigation Clinique, INSERM CIC1405, CHU de Clermont-Ferrand, France, Direction de la Recherche Clinique et des Innovations, CHU de Clermont-Ferrand, France, Fondation Apicil, NEURO-DOL (UMR 1107 INSERM / UCA), SARL BOUCHARENC, Saint-Chély d'Apcher, France, Rhumatologie, CHU de Clermont-Ferrand, France, Médecine Physique et Réadaptation, CHU de Clermont-Ferrand, France, Médecine du Sport et Explorations Fonctionnelles, CHU de Clermont-Ferrand, France, Université Clermont-Auvergne, France
Leads: University Hospital, Clermont-Ferrand

This content was sourced from clinicaltrials.gov