Occasional anti-inflammatory pills during a walking program for hip or knee osteoarthritis

Who can take part

• Patient, man or woman aged 50 to 70, suffering from uni- or bilateral idiopathic osteoarthritis of the hip or knee, whose diagnosis is confirmed by compliance with the radio-clinical criteria of the American College of Rheumatology (Altman et al., 1986): Joint pain felt for at least half the time during the last 3 months prior to inclusion /Morning stiffness lasting less than 30 minutes or joint crackling / Kellgren and Lawrence stage ≥ 2 attested by an available x-ray
• Walking pain rated at least 4 on a scale of 0 (no pain) to 10 (worst imaginable pain), associated with consequent limitation of walking ability (declarative)
• Weekly number of significant trips (walking of at least 20 minutes or 1000 meters) < 3
• Ability to comply with protocol requirements and provide informed consent to participate in research
• Comprehension and fluent writing of the French language
• Coverage by a Social Security scheme

Who cannot take part

• ­Forecast during the period of the initiation study of a non-pharmacological analgesic treatment different from that proposed by the protocol, such as physiotherapy, behavioral therapy (self-management of pain, hypnosis, sophrology, meditation, mindfulness)
• ­Interventional surgery on one or more joints concerned, in the 6 months preceding the scheduled inclusion during the study period
• ­Arthroscopy of one or more joints concerned, within 3 months prior to inclusion or scheduled during the study period
• Other major surgery scheduled during the study period
• ­Chronic pain (especially neuropathic) concomitant with joint pain, considered severe enough to be an obstacle to walking
• ­History of haemorrhage or gastrointestinal perforation during previous treatment with NSAIDs
• Alcohol dependence or known drug use (e.g. non-prescription opioids, amphetamines, cannabis, cocaine, phencyclidine, etc.)
• Regular concomitant treatment with NSAIDs (taking an anti-aggregating dose of aspirin is possible and will influence the patient's risk classification)
• ­Concomitant topical NSAID treatment (can be suspended for the duration of the study)
• ­ Provision during the period of the initiation study of a pharmacological analgesic treatment different from that proposed by the protocol, including systemic corticosteroid
• ­Causal pathology of the suspected or proven arthropathy, such as: inflammatory rheumatism, septic arthritis, recent osteonecrosis, hemochromatosis, Wilson's disease, gout, acromegaly
• ­Other general osteo-articular pathology such as Paget's or Reiter's disease
• ­Hypersensitivity to one of the excipients of a treatment provided for in the protocol, which cannot be replaced by an equivalent formulation
• ­ History of hypersensitivity reactions such as: angioedema, asthma, bronchospasm, nasal polyps, rhinitis, urticaria, or other allergic reactions triggered by taking NSAIDs or acetylsalicylic acid
• Active peptic ulcer, history of peptic ulcer or recurrent bleeding (2 or more distinct episodes of documented bleeding or ulceration)
• Congestive heart failure (EF < 40%)
• Insulin-requiring diabetes
• Known bleeding disorder
• Hypersensitivity to paracetamol
• Hypersensitivity to proton pump inhibitors, if protocol-specified clinical conditions indicate such treatment
• According to the NSAID indicated by the clinical conditions provided for in the protocol: ibuprofen: evolving haemorrhage / diclofenac: ischemic heart disease, peripheral arterial disease and/or history of cerebrovascular accident (including transient ischemic attack)
• Presence of any medical condition deemed incompatible with the study by the investigator
• Severe hepatocellular insufficiency, or liver transplantation, or plasma levels of hepatic transaminases exceeding two and a half times the upper limit of normal according to laboratory standards
• Renal impairment defined by an estimated creatinine clearance < 60 mL/min (MDRD) or renal transplantation, or serum creatinine exceeding one and a half times the upper limit of the normal according to laboratory standards
• Concomitant treatment that cannot be suspended during the trial: any agent known to be nephrotoxic / acetylsalicylic acid at anti-inflammatory doses (≥ 1g/dose and/or ≥ 3g/d), and at analgesic or antipyretic doses (≥ 500mg/dose and/or < 3g/d) / anticoagulant (AVK or AOD) / lithium / methotrexate, pemetrexed / ciclosporin, tacrolimus / tenofovir, disoproxil / glucocorticoid / deferasirox / pentoxifylline / potassium-sparing diuretics, potassium / According to the NSAID indicated by the clinical conditions provided for in the protocol : ketoprofen: cardiac glycosides, nicorandil ; diclofenac: digoxin, cytochrome CYP2C9 inhibitors, phenytoin, quinolones
• ­Pregnant or breastfeeding woman
• ­ Use of a unicompartmental unloading hinged orthosis (indicated for pain predominant in a femoro-tibial compartment of the knee) initiated during the 2 months preceding inclusion, or scheduled during the study period (continuation of older use is possible)
• ­Intra-articular injection of glucocorticoid into the affected joint(s), during the 2 months preceding inclusion, or scheduled during the study period
• ­Visco-supplementation in one or more joints concerned, during the 2 months preceding inclusion, or scheduled during the study period
• ­Intramuscular injection of glucocorticoid during the month preceding inclusion
• ­Possible progressive hematological or cancerous pathology (with the exception of a basal cell carcinoma for which total excision was recently performed)
• ­Immunodepression
• Person under guardianship, curatorship or safeguard of justice, or deprived of freedoms
• Uncontrolled high blood pressure
• ­Weight < 40 kg or body mass index (BMI) < 19 kg.m–2
• Regular intake of strong or substitute opioids (occasional intake of a strong opioid, or regular intake of tramadol or a weak opioid and paracetamol combination is possible)
• ­Weight > 130 kg or body mass index (BMI) > 35 kg.m–2
• Participation in another clinical trial, or in a period of exclusion from another clinical trial
• ­Ambulation not possible
• ­Use of walking aids other than: cane, crutch, orthosis, knee brace
• ­Introduction during the month preceding the inclusion of a new analgesic treatment, pharmacological or not