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临床试验/NCT04119310
NCT04119310Unknown不适用

Lumbar Thrust-mobilization Effects on Hip Strength and Anterior Knee Pain, a Double Blind Randomized Control Trial

Messiah College0 个研究点目标入组 128 人开始时间: 2019年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
128
主要终点
Change in lateral hip strength

研究概览

简要总结

The purpose of this study is to investigate changes in lateral hip muscle strength as well as self-reported pain during the performance of three functional tests in patients with anterior knee pain following a lumbopelvic thrust-mobilization.

Hypothesis(es):

Lumbar thrust-mobilization will lead to increased lateral hip strength and decreased anterior knee pain during 3 functional activities (single leg step down, functional squat, drop jump).

详细描述

The participant will complete a medical history form and undergo a brief physical exam of the lumbar spine and knees to include: lumbar range of motion and mobility testing, knee range of motion, palpation, and knee mobility testing. The participant will complete a hip strength test utilizing the Biodex System 4 Pro®. The participant will then perform three activities (single leg step down, squat, and drop jump from a 2 foot platform) and provide a self-reported knee pain measure with each activity. A sealed envelope indicating the intervention to be received will be given to the participant. An investigator blinded to the pre and post-measures will open the envelope indicating the intervention to be performed. The participant will be blinded to which intervention group they are categorized to. Th e participant will be positioned on a high-low treatment table to receive the assigned intervention. The participant will be positioned to receive either intervention 1 (thrust mobilization) or 2 (sham mobilization). The participant will either receive the thrust-mobilization or sham mobilization up to 2 times on the left and right side. An immediate re-test of hip strength will be conducted followed by performing the same three functional activities (single leg step down, squat, and drop jump from a 2 foot platform) while providing a self-reported pain measure after each activity. Follow-up measures at 15 minutes post-intervention and the final measure at 30 minutes post-intervention will be performed.

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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Double Blind: The subjects will not know what intervention they are receiving - same generic script is provided. One Investigator is performing all pre and post-tests without knowledge of intervention, the other investigator is opening the envelope and providing the intervention behind a screen without knowledge of test results. This investigator will record the subjects assigned # and which intervention they received. Investigators will record data on spreadsheet separately.

The outcomes will be evaluated by a masked outcome assessor.

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy males and females between the ages of 18 and 25 with non-traumatic anterior knee pain
  • Able read and write in English
  • Clearly understand the informed consent form

排除标准

  • Low back pain
  • Pregnant or may be pregnant
  • Previously diagnosed with spondylolisthesis,
  • Previously diagnosed with a herniated disc,
  • Signs and symptoms of nerve root compression
  • History of spine surgery
  • History of knee surgery
  • History of cancer
  • History of compression fracture
  • History of osteoporosis
  • History of osteopenia
  • History of a systemic disease
  • History of a connective tissue disease
  • History of a neurological disease
  • Pain with pre-manipulative hold
  • Positive findings on medical history form, or physical exam
  • Presence of anxiety during the procedure

研究组 & 干预措施

Lumbar thrust-mobilization

Experimental

The investigator will perform a lumbar thrust-mobilization with the subject in right and then left sidelying position

干预措施: Lumbar-thrust mobilization (Other)

Sham-mobilization

Sham Comparator

No lumbar-thrust mobilization will be performed. Subject will receive simple passive inter-vertebral range of motion.

干预措施: Sham thrust-mobilization (Other)

结局指标

主要结局

Change in lateral hip strength

时间窗: Pre-intervention, immediately following intervention, 15 min post-intervention & 30 min post-intervention

lateral isometric hip strength will be measured with Biodex system 4

Change in pain with double leg squat

时间窗: Pre-intervention, immediately following intervention, 15 min post-intervention & 30 min post-intervention

Subject will provide level of anterior knee pain via Visual Analogue Scale (VAS) while performing a double leg squat. The VAS pain scale is a 0 to 10 scale, 0 indicates no pain, 5 indicates distressing pain, 10 indicates unbearable pain. Any whole number between 0 and 10 may be chosen. 0 is better and 10 is worse.

Change in pain with drop jump from 2 foot platform

时间窗: Pre-intervention, immediately following intervention, 15 min post-intervention & 30 min post-intervention

Subject will provide level of anterior knee pain via Visual Analogue Scale (VAS) while performing a drop jump from a 2 foot platform. The VAS pain scale is a 0 to 10 scale, 0 indicates no pain, 5 indicates distressing pain, 10 indicates unbearable pain. Any whole number between 0 and 10 may be chosen. 0 is better and 10 is worse.

Change in pain with single leg step down

时间窗: Pre-intervention, immediately following intervention, 15 min post-intervention & 30 min post-intervention

Subject will provide level of anterior knee pain via Visual Analogue Scale (VAS) while performing a single leg step down. The VAS pain scale is a 0 to 10 scale, 0 indicates no pain, 5 indicates distressing pain, 10 indicates unbearable pain. Any whole number between 0 and 10 may be chosen. 0 is better and 10 is worse.

次要结局

未报告次要终点

研究者

发起方
Messiah College
申办方类型
Other
责任方
Sponsor

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