Patient Walking Rehabilitation Program with osteoarthritis of the hip or knee helped by a one-off anti-inflammatory treatment (pilot cohort study with short walking objectives) - PERIPATEI

Phase 1

Recruiting

• Conditions: Idiopathic osteoarthritis of the hip or knee; MedDRA version: 20.0Level: LLTClassification code: 10003416Term: Arthrosis Class: 10028395; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]

• Registration Number: CTIS2022-502018-10-00
• Lead Sponsor: niversity Hospital Of Clermont-Ferrand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-30
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

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

Exclusion Criteria

­Pregnant or breastfeeding woman, ­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), ­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, ­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, ­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, ­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, ­Chronic pain (especially neuropathic) concomitant with joint pain, considered severe enough to be an obstacle to walking, ­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, ­History of haemorrhage or gastrointestinal perforation during previous treatment with NSAIDs, Active peptic ulcer, history of peptic ulcer or recurrent bleeding (2 or more distinct episodes of documented bleeding or ulceration)., 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, Uncontrolled high blood pressure, ­Weight < 40 kg or body mass index (BMI) < 19 kg.m–2, Congestive heart failure (EF < 40%), Insulin-requiring diabetes, Known bleeding disorder, Alcohol dependence or known drug use (e.g. non-prescription opioids, amphetamines, cannabis, cocaine, phencyclidine, etc.)., 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)., Hypersensitivity to paracetamol, Hypersensitivity to proton pump inhibitors, if protocol-specified clinical conditions indicate such treatment, According

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified