Helping Osteoarthritis Patients to Walk With NSAID

NCT05761015 | Recruiting Phase 4

• 1 other identifier: RBHP 2022 DUALE
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip; Chronic Pain

Keywords

Osteoarthritis, Knee; Osteoarthritis, Hip; pain at movement; nonsteroidal anti-inflammatory drug; acetaminophen; paracetamol; personalized medicine; pharmacovigilance

Outcome Measures

Primary Outcomes (1)

• Success

  success of the therapeutic program (defined by a 30%-increase (or more) of the monthly number of target moves from the baseline observation values, with no treatment discontinuation for NSAID side effects)

  V1 (pre-intervention visit) + 12 weeks

Secondary Outcomes (13)

• Self-declared physical activity (efficacy outcome)

  V1 (pre-intervention visit)

• Self-declared physical activity (efficacy outcome)

  V1 (pre-intervention visit) + 6 weeks

• Self-declared physical activity (efficacy outcome)

  V1 (pre-intervention visit) + 12 weeks

• Actual physical activity (efficacy outcome)

  V1 (pre-intervention visit)

• Actual physical activity (efficacy outcome)

  V1 (pre-intervention visit)+ 6 weeks

Other Outcomes (23)

• impairment of renal function (tolerance outcome)

  V0 (inclusion)

• impairment of renal function (tolerance outcome)

  V1 (pre-intervention visit) + 6 weeks

• impairment of renal function (tolerance outcome)

  V1 (pre-intervention visit)+ 12 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

there is only one intervention arm and no control arm; the Bayesian analysis will be conducted under hypothetical estimates of superiority vs. control.

Drug: therapeutic program including intermittent drug intake and multimodal rehabilitation program

Interventions

therapeutic program including intermittent drug intake and multimodal rehabilitation program DRUG

The prescribed NSAID molecule shall be chosen according to the patient's risk profile: * gastric/duodenal risk: age \>65, history of ulcer with remission, history of inflammatory event, current low-dose acetylsalicylic acid treatment ; * cardiovascular risk (according to Agostino scale \& SCORE); The molecule with therefore be: * no risk: niflumic acid, 250 mg per intake; * gastric/duodenal risk only: diclofenac, 50-100 mg per intake, plus lansoprazole; * cardiovascular risk only: ketoprofen, 50-100 mg per intake; * double risk: ibuprofen, 200-400 mg per intake, plus lansoprazole. For the walk test, the highest dose of diclofenac or ketoprofen will be used. Then, the patient will be free to half the dose if pain relief is achieved so. One gram of acetaminophen will be added to any NSAID intake. The number of intakes will be limited to twice a day (morning and evening) and to 10 times a week.

Intervention

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Fondation Apicil: collaborator
• Plateforme d'Investigation Clinique, INSERM CIC1405, CHU de Clermont-Ferrand, France: collaborator
• Médecine Physique et Réadaptation, CHU de Clermont-Ferrand, France: collaborator
• Médecine du Sport et Explorations Fonctionnelles, CHU de Clermont-Ferrand, France: collaborator
• Rhumatologie, CHU de Clermont-Ferrand, France: collaborator
• Direction de la Recherche Clinique et des Innovations, CHU de Clermont-Ferrand, France: collaborator
• SARL BOUCHARENC, Saint-Chély d'Apcher, France: collaborator
• Université Clermont-Auvergne, France: collaborator
• NEURO-DOL (UMR 1107 INSERM / UCA): collaborator

Study Sites (1)

CHU Clemront-Ferrand

Clermont-Ferrand, France

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip; Chronic Pain

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lise Laclautre

CONTACT

04 73 75 11 95; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: cohort

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 9, 2023
• Study Start: December 14, 2023
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)