Helping Osteoarthritis Patients to Walk With NSAID
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.
Timeline
- Start
- 2023-12-14
- Primary completion
- 2028-04
- Completion
- 2028-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Diclofenac | Other / unclassified | 50 mg | Oral |
| Subject | Diclofenac | Other / unclassified | 100 mg | Oral |
| Subject | Ibuprofen | Small molecule | 200 mg | Oral |
| Subject | Ibuprofen | Small molecule | 400 mg | Oral |
| Subject | Ketoprofen | Small molecule | 50 mg | Oral |
| Subject | Ketoprofen | Small molecule | 100 mg | Oral |
| Subject | niflumic acid | Small molecule | 250 mg | Oral |
| Background | Acetaminophen | Small molecule | 1000 mg | — |
| Background | Lansoprazole | Other / unclassified | — | — |