Helping Osteoarthritis Patients to Walk With NSAID
RecruitingPhase 4NCT05761015
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- 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.
- Interventions
- Drug: therapeutic program including intermittent drug intake and multimodal rehabilitation program
- Sponsor
- University Hospital, Clermont-Ferrand
- Collaborators
- Fondation Apicil; SARL BOUCHARENC, Saint-Chély d'Apcher, France; Université d'Auvergne; NEURO-DOL (UMR 1107 INSERM / UCA)
- Start date
- 2023-12-14
- Primary completion
- 2028-04
- Sex
- All
- Age range
- from 50 Years to 70 Years
- Results posted
- No results posted in this snapshot
- Countries
- France
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Exclusion Criteria: * 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…). * 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. * Planned intervention similar to those abovementioned, during 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. * Current cancer disease. * Immunosuppression. * Autoimmune disease. * Concomitant topical or systemic NSAID treatment. * Chronic strong opioid intake. * Concomitant insulin therapy. * Any absolute or relevant contraindication to NSAIDs or acetaminophen, according to the French drug agency
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05761015