跳至主要内容
临床试验/NCT05769998
NCT05769998招募中不适用

Development and Improvement of an Acceptance and Commitment-based Treatment for the Prevention of Chronic Pain After Total Knee Arthroplasty

Istituto Auxologico Italiano2 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2021年6月15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
210
试验地点
2
主要终点
Number of days for pain disappearance

研究概览

简要总结

Reducing the incidence of chronic post-surgical pain after Total Knee Arthroplasty (TKA) is paramount. NOPAIN, a technology-enhanced Acceptance and Commitment-based treatment, will be developed, tested and improved for this purpose. The feasibility of NOPAIN will be evaluated in a small sample of patients listed for TKA at the IRCCS Istituto Auxologico Italiano. Potential pre-surgical and post-surgical predictors of non-response to treatment will be measured and tested using a machine learning algorithm. The results of this study will be employed to improve the content of NOPAIN or for identification of criteria for patient selection. Finally, a randomized controlled clinical trial will be performed. Patients listed for TKA will be randomized to Treatment As Usual (TAU) or to NOPAIN+TAU. Primary outcome will be time to complete pain relief, secondary outcomes will include subjective and objective measurements of quality of life and functional recovery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • having an age between 18 and 80 years
  • having a diagnosis of OA as determined by medical record review
  • having undergone a Total Knee Arthroplasty

排除标准

  • Inability to provide informed consent

结局指标

主要结局

Number of days for pain disappearance

时间窗: 6 months

The first among five consecutive days with pain intensity \<3 on a 0-10 Numeric Rating Scale

次要结局

  • Presence of chronic pain(6 months)
  • Pain intensity(6 months)
  • Physical and Mental Quality of Life(6 months)
  • Knee pain, stiffness and physical function(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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