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临床试验/NCT03101956
NCT03101956已完成不适用

Spinal Manipulation for Improving Hip and Knee Muscle Strength in Patients With Patellofemoral Pain Syndrome - A Randomized, Placebo-Controlled, Clinical Trial

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2017年3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
42
试验地点
1
主要终点
Muscle Strength using dynamometer

研究概览

简要总结

The aim of this double blind, randomized, placebo-controlled clinical trial is to investigate the immediate effects of spinal manipulation on hip and knee muscle strength and pain-free deep squat range of motion in order to answer several conceptual and practical research questions

详细描述

This prospective, double-blind, randomized control trial clinical will use a multigroup pretest-posttest control design with 1 treatment arm and 1 control arm. Interpreted within the biopsychosocial model and the International Classification of Functioning, Disability and Health (ICF) framework, this research will measure the outcomes between patellofemoral pain syndrome (PFPS), the health condition, and contextual factors, particularly personal factors. It will address personal factors such as gender and age but will not address environmental factors. This research includes tests and measures of two of the three levels of human functioning, or domains, impairments to body functions and structures and activity limitations. Muscle strength testing is an impairment-level measure and pain-free deep squat range of morion (ROM) is an activity limitation-level measure.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Referred to out-patient physical therapy for a knee condition and a chief complaint of anterior knee pain
  • Anterior knee pain with squatting
  • Agreed to be in the study and signed the informed consent document

排除标准

  • Presence of any medical 'red flags' suggestive of pain that is not of musculoskeletal origin
  • Osteoporosis or recent fracture of the hip or spinal joints
  • Spinal or hip joint surgery or prosthesis
  • Knee surgery on the affected knee within the last 6 months
  • Spinal instability (Grade II spondylolithesis or greater), spondyloarthritides, or severe spinal misalignment
  • Nervous system disease or disorder
  • Lumbar nerve root compression (any of the following signs present)
  • Positive straight leg raise (SLR) test less than 45°
  • Marked paresis involving a major muscle group of the lower extremity
  • Diminished, and asymmetric (lower than uninvolved side), lower extremity
  • muscle stretch reflex
  • Diminished or absent sensation to pinprick in any lower extremity dermatome

结局指标

主要结局

Muscle Strength using dynamometer

时间窗: 1 Day

Hand-held dynamometry involves the use of a dynamometer that is held by a tester and applied to the tested segment of a patient's body.

Score on European Quality of Life-5 Dimensions Questionnaire (EQ-5D)

时间窗: 1 Day

The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems

次要结局

  • Subject's report of pain on the Numeric Pain Rating Scale (NPRS) at rest(1 Day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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Lumbar Manipulation for Hip and Muscle Strength | 临床试验