Helping Osteoarthritis Patients to Walk With NSAID

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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.

Eligibility

Primary outcome measure(s)

• Success — V1 (pre-intervention visit) + 12 weeks
  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)

Trial sites (1)

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