Helping Osteoarthritis Patients to Walk With NSAID

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age50-70
SponsorUniversity Hospital, Clermont-Ferrand

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Pregnancy or breastfeeding

Legal protection

Body weight < 40 kg or underweight

Body weight >120 kg or obesity

Trial design

Treatments tested in this trial

  • therapeutic program including intermittent drug intake and multimodal rehabilitation program

Treatment groups

55 Participants
are divided into 1 treatment group

Sponsors and collaborators

University Hospital, Clermont-Ferrand

Lead sponsor

Fondation Apicil

Collaborator

SARL BOUCHARENC, Saint-Chély d'Apcher, France

Collaborator

Université Clermont-Auvergne, France

Collaborator

NEURO-DOL (UMR 1107 INSERM / UCA)

Collaborator