Helping osteoarthritis patients walk with NSAIDs
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.
This study is testing a new program that combines special exercises and occasional use of pain relief medications to help people with hip or knee osteoarthritis walk better.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 50 Years to 70 Years |
| Sex | All |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Locations | 1 site (Clermont-Ferrand) |
| Trial ID | NCT05761015 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to improve walking ability in patients with painful hip or knee osteoarthritis through a multimodal rehabilitation program combined with intermittent use of nonsteroidal anti-inflammatory drugs (NSAIDs). The study involves a single-center, non-randomized, open-label design where participants will undergo assessments and interventions over a 12-week period. Patients will receive tailored footwear, education on managing pain and side effects, and will track their pain and activity levels throughout the study. The goal is to optimize pain relief while minimizing the risks associated with continuous NSAID use.
Who should consider this trial
Good fit: Ideal candidates are individuals with unilateral or bilateral hip or knee osteoarthritis experiencing moderate pain while walking.
Not a fit: Patients with secondary osteoarthritis or those unable to walk without support devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the quality of life for osteoarthritis patients by improving their ability to walk with reduced pain.
How similar studies have performed: While the use of NSAIDs in osteoarthritis management is common, this specific multimodal approach is novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Clermont-Ferrand
- CHU Clemront-Ferrand — Clermont-Ferrand, France (Recruiting)
Study contacts
- Study coordinator: Lise Laclautre
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: 04 73 75 11 95
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.