2022-502018-10-00招募中4 期
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
University Hospital Of Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2023年1月18日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- For a given individual, the main criterion is the success of the therapeutic program, defined by an increase of at least 30% in the monthly number of target movements compared to the month of basal observation, in the absence of treatment discontinuation. NSAIDs for intolerance
研究概览
简要总结
Study the efficacy and tolerance of the reasoned and punctual intake of a non-steroidal anti-inflammatory drug (NSAID), as part of a walking rehabilitation program for patients suffering from osteoarthritis of the hip or knee.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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 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)
- •Regular concomitant treatment with NSAIDs (taking an anti-aggregating dose of aspirin is possible and will influence the patient's risk classification)
- •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
- •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
- •Presence of any medical condition deemed incompatible with the study by the investigator
- •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
- •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
结局指标
主要结局
For a given individual, the main criterion is the success of the therapeutic program, defined by an increase of at least 30% in the monthly number of target movements compared to the month of basal observation, in the absence of treatment discontinuation. NSAIDs for intolerance
For a given individual, the main criterion is the success of the therapeutic program, defined by an increase of at least 30% in the monthly number of target movements compared to the month of basal observation, in the absence of treatment discontinuation. NSAIDs for intolerance
次要结局
未报告次要终点
研究者
Lise Laclautre
Scientific
University Hospital Of Clermont-Ferrand
研究点 (1)
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