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临床试验/NCT06330402
NCT06330402已完成不适用

Undersøgelse af sammenhængen Mellem Biomekanik og Smerter Ved Gang

Kristian Kjær Petersen2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2023年9月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
34
试验地点
2
主要终点
Infrared marker XYZ coordinates

研究概览

简要总结

This interventional study aims to test gait biomechanics in healthy individuals with and without experimental knee pain. The main questions it aims to answer are:

  • How do gait patterns change during painful walking?
  • Can pain sensitivity testing and gait biomechanics predict experimental knee pain intensity?

Participants will receive two knee injections: a) Hypertonic saline (painful condition) and b) Isotonic saline (control condition).

详细描述

This study will be a randomized, crossover design where experimental knee pain will be provoked in healthy subjects using hypertonic saline injections to the infrapatellar fat pad (IFP). This will be controlled with a second injection of isotonic saline, which is non-painful. The participants will not be informed of the type of injection.

Hypertonic saline injections to the IFP usually provoke pain lasting about 15 minutes. Within this timeframe, motion capture will be conducted to estimate the biomechanics of gait. During the motion capture the participants will perform five 10-meter walking trials and three jumps. This process will be replicated for the control condition.

Additionally, the participants will have their pain sensitivity tested using cuff-pressure algometry before both IFP injections.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy men and women aged 18-45 years

排除标准

  • Pregnancy
  • Drug addiction, defined as the use of cannabis, opioids, or other drugs
  • Previous or current neurologic or musculoskeletal illnesses
  • Current pain
  • Lack of ability to cooperate

研究组 & 干预措施

Painful condition

Experimental

Hypertonic saline injection to the infrapatellar fat pad.

干预措施: Hypertonic saline injection (Other)

Control condition

Placebo Comparator

Isotonic saline injection to the infrapatellar fat pad.

干预措施: Isotonic saline injection (Other)

结局指标

主要结局

Infrared marker XYZ coordinates

时间窗: Baseline

Marker-based motion capture with infrared cameras will be used to estimate placement of reflective markers in the XYZ planes measured in milimeters. Reflective markers will be placed from head-to-toe on anatomical landmarks.

Pain sensitivity.

时间窗: Baseline

Cuff-pressure algometry will be used to estimate pressure detection and tolerance thresholds, temporal summation of pain, and conditioned pain modulation.

次要结局

  • Ground reaction forces(Baseline)
  • Ground reaction moments(Baseline)
  • The Pittsburgh Sleep Quality Index score(Baseline)
  • The Pain catastrophizing Scale score(Baseline)
  • The Hospital Anxiety and Depression Scale(Baseline)
  • Knee symptoms(Baseline)
  • Muscle activation(Baseline)
  • Ground contact XZ location(Baseline)

研究者

发起方
Kristian Kjær Petersen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kristian Kjær Petersen

Principal Investigator

Aalborg University

研究点 (2)

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