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临床试验/NCT07410884
NCT07410884已完成不适用

Temporal Associations Between Pain Intensity and Disturbed Body Perception After Total Knee Arthroplasty: A Random-Intercept Cross-Lagged Panel Model Analysis

Prefectural University of Hiroshima1 个研究点 分布在 1 个国家目标入组 285 人开始时间: 2019年10月8日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
285
试验地点
1
主要终点
Knee Pain Intensity at Rest (100-mm Visual Analogue Scale)

研究概览

简要总结

This observational study aims to better understand how knee pain and knee-specific body perception are related over time after total knee arthroplasty (knee replacement) for knee osteoarthritis. Although most people improve after surgery, some continue to experience ongoing pain. Disturbed body perception such as feeling that the knee is less clear, less familiar, or difficult to "sense" or "control" as usual-has been linked to chronic musculoskeletal pain, but the timing of its relationship with postoperative pain after knee replacement is not well understood.

Adults undergoing primary total knee arthroplasty at Fukuoka Orthopaedic Hospital will be invited to participate. Participants will be asked to complete brief self-report questionnaires about (1) knee pain intensity during movement, (2) knee pain intensity at rest, and (3) knee-specific body perception (how the knee feels and is perceived). Pain intensity will be recorded using 100-mm visual analogue scales, and knee-specific body perception will be assessed using a validated questionnaire. Questionnaires will be completed before surgery (within one week prior) and at 1, 3, 6, and 12 months after surgery.

All surgical and rehabilitation care will be provided as part of usual clinical practice. Participation in this study involves completing questionnaires only and does not change clinical care. The study will examine whether within-person changes in knee body perception are associated with later changes in pain intensity across the first postoperative year, while also accounting for stable differences between individuals.

Information from this study may help identify potentially modifiable factors associated with persistent pain after knee replacement and may inform future research on rehabilitation strategies that target body perception and related sensorimotor processes. Study data will be handled confidentially in accordance with institutional policies, and analyses will be conducted on de-identified data whenever possible.

详细描述

Knee osteoarthritis is a common cause of pain and disability, and total knee arthroplasty (TKA) is frequently performed to improve symptoms and function. Although many people experience substantial improvement after surgery, a subset report ongoing pain during recovery. Disturbed body perception (e.g., reduced clarity, altered awareness, or a sense that the knee feels unfamiliar) has been associated with persistent musculoskeletal pain, but the temporal ordering of postoperative pain and knee-specific body perception after TKA remains unclear.

This observational cohort study follows adults undergoing primary TKA and examines longitudinal associations between pain intensity (during movement and at rest) and knee-specific body perception across the first postoperative year. Participants complete brief self-report questionnaires at preoperative baseline and at multiple postoperative follow-up time points through 12 months. Clinical care (surgery, analgesia, and rehabilitation) is provided as usual and is not altered by study participation; the study procedures involve completion of questionnaires only.

The primary objective is to evaluate whether within-person changes in knee-specific body perception are prospectively associated with later within-person changes in pain intensity over time, while accounting for stable between-person differences. Longitudinal analyses will use random-intercept cross-lagged panel modeling to separate trait-like, between-person stability from state-like, within-person fluctuations and to estimate autoregressive and cross-lagged associations across adjacent waves. Missing questionnaire data will be handled using full-information maximum likelihood under a missing-at-random assumption, and sensitivity analyses will be conducted using the complete-case sample to evaluate robustness. Descriptive summaries and correlations will be used to characterize the observed trajectories and concurrent associations across time points.

The study is conducted in accordance with institutional ethical approval and written informed consent. Data are managed confidentially in line with institutional policies, and analyses are performed on de-identified data whenever possible. Findings are intended to inform future research on potentially modifiable factors related to persistent pain after TKA and to support development of rehabilitation strategies that may incorporate body perception-related approaches.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
50 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • undergoing primary TKA for knee OA
  • ability to understand and complete study questionnaires
  • provision of informed consent.

排除标准

  • prior knee surgery on the affected knee
  • significant neurological or cognitive impairment
  • diagnosis of rheumatoid arthritis
  • having undergone unicompartmental knee arthroplasty (UKA).

研究组 & 干预措施

Adults Undergoing Primary Total Knee Arthroplasty for Knee Osteoarthritis

This cohort includes adults scheduled for primary total knee arthroplasty (TKA) for knee osteoarthritis at Fukuoka Orthopaedic Hospital. Participants are followed from the preoperative period through 12 months after surgery. The study is observational and does not assign any experimental intervention. Surgical care, postoperative analgesia, and rehabilitation are provided as part of usual clinical practice based on standard hospital protocols. The exposures of interest are within-person changes in knee-specific body perception and pain intensity over time. Participants complete self-report questionnaires assessing knee pain intensity during movement and at rest (100-mm visual analogue scales) and knee-specific body perception (Fremantle Knee Awareness Questionnaire) before surgery and at 1, 3, 6, and 12 months after surgery.

结局指标

主要结局

Knee Pain Intensity at Rest (100-mm Visual Analogue Scale)

时间窗: Baseline (preoperative, within 1 week prior to surgery) and 1, 3, 6, and 12 months after total knee arthroplasty

Resting pain intensity is assessed using a 100-mm visual analogue scale (VAS) anchored by "no pain" (0) and "worst possible pain" (100). Participants respond to: "Over the past week, how intense is your knee pain at rest?" and rate their average resting pain over the past week.

Knee-Specific Body Perception Disturbance (Fremantle Knee Awareness Questionnaire; FreKAQ)

时间窗: Baseline (preoperative, within 1 week prior to surgery) and 1, 3, 6, and 12 months after total knee arthroplasty

Knee-specific body perception disturbance is assessed using the Fremantle Knee Awareness Questionnaire (FreKAQ). Items are rated on a 5-point Likert scale (0=never to 4=always) and summed to a total score (range 0-36), with higher scores indicating greater disturbance in knee-specific body perception.

Knee Pain Intensity During Movement (100-mm Visual Analogue Scale)

时间窗: Baseline (preoperative, within 1 week prior to surgery) and 1, 3, 6, and 12 months after total knee arthroplasty

Pain intensity during movement is assessed using a 100-mm visual analogue scale (VAS) anchored by "no pain" (0) and "worst possible pain" (100). Participants respond to: "Over the past week, how intense is your knee pain during movement?" and rate their average pain during usual daily activities (e.g., level walking, sit-to-stand, stair negotiation).

次要结局

未报告次要终点

研究者

发起方
Prefectural University of Hiroshima
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tomohiko Nishigami

Professor

Prefectural University of Hiroshima

研究点 (1)

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