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临床试验/NCT07110324
NCT07110324招募中不适用

Characteristics of Persistent Pain Composition Following Total Hip or Knee Arthroplasty: a Descriptive Study

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年6月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Potential nociplastic pain

研究概览

简要总结

Despite high success rates of hip and knee arthroplasty, up to 20% of patients report moderate-to-severe pain (NRS > 3) persisting beyond the expected healing period. This investigator-initiated, descriptive cohort study will re-invite approximately 100 consenting patients with persistent postoperative pain-identified from a pool of ~7 000 respondents-to complete standardized assessments of neuropathic (DN4), nociplastic (IASP criteria + Fibromyalgia Survey Questionnaire) and nociceptive (KOOS/HOOS pain domains) pain. Primary outcomes are the prevalence of potential nociplastic pain and the proportion experiencing significant pain in two or more mechanistic categories. Secondary analyses will compare baseline vs. re-evaluated DN4 scores, FSQ and KOOS/HOOS distributions, and examine differences between patients with and without possible neuropathic pain. Findings will inform targeted pre- and postoperative pain management strategies.

详细描述

Introduction Background: Knee and hip arthroplasties are primarily performed due to degenerative changes that typically result in pain, functional impairment, and a subsequent decline in quality of life [1]. Arthroplasty represents the definitive intervention, involving the removal of the degenerated, pain-inducing joint components and their replacement with artificial prostheses. These procedures are considered standard in orthopedic surgery, boasting high success rates and high levels of patient satisfaction [2,3,4]. Nevertheless, the surgeries are not without risks, including perioperative complications such as infection, thrombosis, and prosthetic dislocation. Additionally, the economic burden on healthcare systems is considerable, encompassing not only the costs of the surgery itself but also postoperative care and rehabilitation. Hence, it is essential that the procedure yields the desired pain-relieving and functional outcomes to justify its use. Osteoarthritis is the primary indication for arthroplasty, representing a leading cause of disability worldwide. In advanced stages of osteoarthritis, the pain profile can become multifaceted, often involving a combination of nociceptive, neuropathic, and nociplastic pain mechanisms. Nociceptive pain, stemming from joint tissue damage and inflammation, is the most prevalent form and is usually effectively managed by arthroplasty. However, the complexity of pain perception in osteoarthritis extends beyond the joint, potentially involving altered pain processing pathways within the central and peripheral nervous systems. Up to 20% of patients report significant persistent pain following arthroplasty despite uncomplicated surgery and no apparent source of pain. This could be explained by the presence of non-nociceptive pain. Neuropathic pain stem from nerve damage, while nociplastic pain is associated with altered central pain processing, leading to pain persisting even after the natural healing process [5]. Identifying the type of pain in patients with persistent post-surgical pain could have important implications for pre-surgical as well as post-surgical management.

Objective: The aim of this study is to explore the pain composition in terms of neuropathic, nociceptive and nociplastic pain in patients with persistent pain after total knee arthroplasty (TKA), total hip arthroplasty (THA), or unicompartmental knee arthroplasty (UKA).

Hypotheses: The investigators hypothesize that postoperative pain with multiple pain types is prevalent and that neuropathic and nociplastic pain is co-existent or conflated in a considerable proportion of patients. Thus, there is an increased prevalence of potential nociplastic pain among patients with a Neuropathic Pain score (DN4) reflecting 'possible neuropathic pain'.

Perspective: Correct identification of pain types has important implications for pain management pre-operatively, peri-operatively, and post-operatively. Moreover, a high proportion of patients with potential nociplastic pain could increase the focus on the link between preoperative patient characteristics and post-operative potential nociplastic pain. This would help targeting those individuals benefiting most from operation compared to non-surgical management. Although results from this post-operative population do not necessarily reflect the prevailing pre-operative pain composition, the results from the study can potentially form the basis for hypothesis testing in a pre-operative cohort.

Methods This protocol was registered before initiation of data collection.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •All patients with persistent moderate-severe pain (NRS>3) after THA, TKA and UKA
  • •Acceptance to be contacted.

排除标准

  • •Re-operation
  • •Do not want to be contacted
  • •Post-operative complications such as prosthesis infection, thromboembolism or fracture of the prosthesis.

结局指标

主要结局

Potential nociplastic pain

时间窗: 1 year

Prevalence of potential nociplastic pain (defined by International Association for the Study of Pain criteria)

次要结局

  • Difference between baseline and re-evaluated neuropathic pain score.(1 year)
  • Distribution of Hip injury and Osteoarthritis Outcome Score (HOOS)(1 year)
  • Prevalence of potential nociplastic pain, as assessed with the Fibromyalgia Survey Questionnaire score.(1 year)
  • Distribution of Knee injury and Osteoarthritis Outcome Score (KOOS)(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Milan Mohammad

Principal Investigator

Rigshospitalet, Denmark

研究点 (1)

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