Fernandes G S, Sarmanova A, Warner S, Harvey H, Akin-Akinyosoye K, Richardson H, Frowd N, Marshall L, Stocks J, Hall M, Valdes A M, Walsh D, Zhang W, Doherty M
Academic Rheumatology, Division of Rheumatology, Orthopedics and Dermatology, School of Medicine, University of Nottingham, Nottingham City Hospital, Nottingham, NG5 1PB, United Kingdom.
Arthritis Research UK Centre for Sports, Exercise and Osteoarthritis, University of Nottingham, Nottingham, NG7 2UH, United Kingdom.
BMC Musculoskelet Disord. 2017 Sep 21;18(1):404. doi: 10.1186/s12891-017-1761-4.
The incidence, progression and related risk factors for recent-onset knee pain (KP) remain uncertain. This study aims to examine the natural history of KP including incidence and progression and to identify possible phenotypes and their associated risk factors.
A prospective community-based cohort of men and women aged 40 years or over within the East Midlands region (UK) will be recruited via a postal questionnaire from their general practices. The questionnaire will enquire about: presence and onset of KP; pain severity (0–10 numerical rating scale (NRS)); pain catastrophizing and neuropathic-like pain (NP) using the painDETECT questionnaires (definite NP scores ≥19–38); risk factors for KP and/ or osteoarthritis (OA) (age, body mass index, constitutional knee alignment, nodal OA, index: ring finger length (2D4D) ratio); quality of life (SF12); and mental health (Hospital Anxiety and Depression Scale). Clinical assessments will be undertaken in a sample of 400 participants comprising three groups: early KP (≤3 year’s duration), established KP (>3 years) and no KP. Assessments will include knee radiographs (standing semi-flexed and 30(0) skyline views); knee ultrasound (synovial effusion, hypertrophy, and Doppler activity); quantitative sensory testing; muscle strength (quadriceps, hip abductor, and hand-grip); balance; gait analysis (GAITrite); and biomarker sampling. A repeat questionnaire will be sent to responders at years 1 and 3. The baseline early KP group will undergo repeat assessments at year 1 (apart from radiographs) and year 3 (with radiographs). Any incident KP individuals identified at year 1 or 3 questionnaires will have clinical and radiographic assessments at the respective time points.
Baseline data will be used to examine risk factors for early onset KP and to identify KP phenotypes. Subsequent prospective data, at least to Year 3, will allow examination of the natural history of KP and risk factors for incidence and progression.
The study was registered on the clinicaltrials.gov portal: NCT02098070) on the 14th of March 2014.
近期发生的膝关节疼痛（KP）的发病率、进展情况及相关危险因素仍不明确。本研究旨在探讨KP的自然病程，包括发病率和进展情况，并确定可能的表型及其相关危险因素。
通过邮政问卷从英国东米德兰兹地区40岁及以上的男性和女性中招募一个基于社区的前瞻性队列。问卷将询问：KP的存在和发病情况；疼痛严重程度（0-10数字评分量表（NRS））；使用疼痛DETECT问卷评估疼痛灾难化和神经性疼痛（NP）（明确的NP评分≥19-38）；KP和/或骨关节炎（OA）的危险因素（年龄、体重指数、膝关节结构对线、结节性OA、指标：无名指长度（2D4D）比值）；生活质量（SF12）；以及心理健康（医院焦虑抑郁量表）。将对400名参与者进行临床评估，分为三组：早期KP（病程≤3年）、已确诊KP（病程>3年）和无KP。评估将包括膝关节X线片（站立半屈曲位和30°（0）天际线位）；膝关节超声（滑膜积液、肥厚及多普勒活动）；定量感觉测试；肌肉力量（股四头肌、髋外展肌和握力）；平衡能力；步态分析（GAITrite）；以及生物标志物采样。在第1年和第3年将向应答者发送重复问卷。基线早期KP组将在第1年（不包括X线片）和第3年（包括X线片）进行重复评估。在第1年或第3年问卷中确定的任何新发KP个体将在各自时间点进行临床和影像学评估。
基线数据将用于检查早期发病KP的危险因素并确定KP表型。至少到第3年的后续前瞻性数据将有助于研究KP的自然病程以及发病率和进展的危险因素。
该研究于2014年3月14日在clinicaltrials.gov网站注册（NCT02098070）。
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