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临床试验/NCT05575310
NCT05575310已完成不适用

Central Sesitization in Patients with Persistent Postsurgical Pain After a Knee Arthroplasty: a Prospective, Case Control, Observational Study

University of Barcelona1 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
117
试验地点
1
主要终点
Conditioned Pain Modulation at 3 months

研究概览

简要总结

Persistent post-surgical pain is a significant adverse effect after total knee arthroplasty, present in around 20% of the patients. Central sensitization may contribute to developing and maintaining pain. Therefore studies should investigate if pain processing altered mechanisms are present in this population.

详细描述

Numerous studies suggest that peripheral and central sensitization in patients with symptomatic knee osteoarthritis could be an important factor capable of explaining part of these poor outcomes after knee arthroplasty. Quantitative sensory testing has been frequently used to investigate this sensitization of the central nervous system and assess pain hypersensitivity locally and away from the affected region in patients with chronic knee osteoarthritis pain. Pressure algometry is a method described to determine pain thresholds to pressure and thus evaluate the sensitivity to pain due to tissue pressure. However, another aspect associated with sensitization is the downward modulation of peripheral inputs. This occurs in neurons in the posterior horn of the medulla and can be either inhibitory or facilitatory. The conditioned pain modulation test is a manifestation of this phenomenon, which can be easily assessed in patients, and is characterized by the modification of the response to the application of a painful stimulus when a second conditioning painful stimulus is applied. Conditioned pain modulation has been shown to be altered in patients with symptomatic knee osteoarthritis.

The literature suggests that although one of the main components of pain perpetuation with people with knee osteoarthritis is sensitization of the nervous system, successful knee arthroplasty is able to normalize its functioning. This implies that the maintenance of sensitization can be triggered by peripheral nociceptive stimuli. When performing a knee arthroplasty, the structures capable of generating these peripheral nociceptive stimuli are eliminated, so that the pain-generating mechanisms cannot be the same as before in those who manifest persistent post-surgical pain. For this reason, one of the hypotheses is that the mechanism responsible for causing this pain is a central mechanism and not a peripheral one. Although this hypothesis has not been fully tested, there are indications that people with chronic post-surgical pain may suffer peripheral and central sensitization processes, very similar to those that can be observed in people with symptomatic osteoarthritis of the knee that is not operated on, even though the structures involved are no longer present. This fact reinforces the theory of the involvement of a central mechanism in the perpetuation of pain after surgery.

Therefore, the present study aims to investigate the involvement of the central sensitization process in the perpetuation of postoperative pain in individuals undergoing total knee arthroplasty for primary symptomatic knee osteoarthritis. From a clinical point of view, current postoperative treatments focus mainly on improving the patient's functional outcomes (e.g., physical function and joint range of motion), and the status of the descending pain modulator system is rarely taken into account. The present study seeks to place importance on the central mechanisms in the perpetuation of pain after knee arthroplasty, to inspire new treatment protocols that take these processes into account.

研究设计

研究类型
Observational
观察模型
Case Control
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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Conditioned Pain Modulation at 3 months

时间窗: 3 months after surgery

Experimental tonic pain will be induced by immersing the hand against the side in cold water following the Cold Pressor Test protocol (CPT). CPT will be performed by holding the contralateral hand immersed in water at 12±1 °C up to the wrist for a period of 2 minutes. The evaluation of pain thresholds to pressure will be performed after 45 seconds of immersion at location 1 of the peripatellar region (bilateral) and to the dominant forearm. Both evaluation points have been described in the section on pressure pain thresholds. The final value corresponding to the conditioned modulation of pain will be obtained from the difference between the value obtained during the application of the conditioning stimulus and the previous value. The unit of measurement will be in kilopascals (kPa) (conditioned pain modulation = pain threshold at pressure during application of cold - pain threshold at pressure before application of cold).

Conditioned Pain Modulation at 6 months

时间窗: 6 months after surgery

Experimental tonic pain will be induced by immersing the hand against the side in cold water following the Cold Pressor Test protocol (CPT). CPT will be performed by holding the contralateral hand immersed in water at 12±1 °C up to the wrist for a period of 2 minutes. The evaluation of pain thresholds to pressure will be performed after 45 seconds of immersion at location 1 of the peripatellar region (bilateral) and to the dominant forearm. Both evaluation points have been described in the section on pressure pain thresholds. The final value corresponding to the conditioned modulation of pain will be obtained from the difference between the value obtained during the application of the conditioning stimulus and the previous value. The unit of measurement will be in kilopascals (kPa) (conditioned pain modulation = pain threshold at pressure during application of cold - pain threshold at pressure before application of cold).

次要结局

  • Pressure Pain Threshold(3 and 6 months after surgery)
  • Health Functioning(3 and 6 months after surgery)
  • Pain intensity(3 and 6 months after surgery)

研究者

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

Marc Terradas Monllor

Dr. Marc Terradas-Monllor

University of Barcelona

研究点 (1)

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