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临床试验/NCT02854774
NCT02854774终止早期 1 期

Neural Mechanisms of Muscle Control in Individuals With Knee Pain

University of Southern California2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2016年8月30日最近更新:
适应症

试验速览

阶段
早期 1 期
状态
终止
入组人数
4
试验地点
2
主要终点
Pain reduction measured using a visual analog scale (VAS) for knee pain

研究概览

简要总结

This is a randomized controlled trial of knee muscle versus hip muscle strengthening for Patellofemoral Pain Syndrome.

详细描述

Rationale: Two prior randomized controlled trials (RCT) have highlighted the importance of hip muscle activation and strengthening as a treatment strategy for patellofemoral pain (Khayambashi, 2014; Khayambashi, 2012). Here, we propose a pilot study to acquire preliminary data to power a larger study to reveal the neural mechanism underlying the effectiveness of this intervention to promote its evidence-based incorporation into clinical practice.

Intervention: 4 weeks of quadriceps muscle versus 4 weeks of hip strengthening exercises.

Purpose: To determine changes in brain functional connectivity related to pain reduction induced by the strengthening exercises.

Study population: Males and females with a history of unilateral knee pain.

Methodology: Functional magnetic resonance imaging (fMRI) will be used to quantify functional connectivity of brain regions related to hip muscle activation. Functional connectivity will be quantified before (pre) and after (post) 4 weeks of quadricep or hip muscle strengthening exercises.

研究设计

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

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

  • Pain located specifically around the patellofemoral articulation (vague or localized).
  • Readily reproducible pain (3 out of 10 on a visual analog scale) with at least 2 of the following functional activities commonly associated with PFP: stair ascent or descent, squatting, kneeling, prolonged sitting, or isometric quadriceps contraction.
  • Reports of pain greater than 3 months duration.

排除标准

  • Previous history of knee surgery.
  • History of traumatic patellar dislocation.
  • Neurological involvement that would influence gait.
  • Contraindications to MR imaging: implanted electronic devices (i.e. pacemaker), or metallic implants (i.e. aneurysm clips, fixation screws).

结局指标

主要结局

Pain reduction measured using a visual analog scale (VAS) for knee pain

时间窗: 4 weeks and 6 months

Compared to baseline

次要结局

  • Brain function measured using fMRI(4 weeks)
  • Muscle activation assessed with electromyographic (EMG) recordings(4 weeks)
  • Knee kinematics assessed with 3-dimensional motion capture(4 weeks)

研究者

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

Jason Kutch

Assistant Professor

University of Southern California

研究点 (2)

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