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临床试验/NCT04487327
NCT04487327已完成不适用

The Effect of Needle Placement on Muscle Stiffness, Gait, Balance, Pain and Functional

Regis University2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
75
试验地点
2
主要终点
DN location effect on self-reported and clinical outcomes

研究概览

简要总结

The purpose of this randomized controlled trial is to assess the effect of DN at either the site of the identified myofascial trigger point/s (MTrP) of in the same muscle, but away from the MTrP site/s in individuals with ankle and/or hindfoot injury. Assessments will be of self-reported outcomes, self-reported pain, gait, balance, muscle stiffness, and pain pressure threshold. The secondary purpose of this study is to determine the validity of dry needling specific muscles of the lower extremity based upon needle placement, location relative to anatomical structures and accuracy of needle placement in muscle using ultrasound imaging.

详细描述

Few studies have assessed the validity of needling muscles of the lower extremity. For muscles such as the tibialis posterior that are not easily accessible or directly palpable secondary to the deep anatomical position and due to the proximity of the tibial nerve and the posterior tibial artery within the deep compartment, examining accurate needle placement is clinically relevant. In addition, DN has been shown to be a beneficial management strategy for individuals with lower extremity condition; however, the investigators may be able to optimize these beneficial effects by performing DN on the MTrP versus other sites within the same muscle.

If needling directly into the MTrP is more effective than needling away from the MTrP but into the same muscle, it is possible that the improved efficiency could help to optimize management of patients with injury to the ankle/hindfoot with less visits and potentially decreasing health care costs.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Study investigators collecting outcome assessments will be blinded to group allocation. Participants will be asked not to reveal what group they believe they were randomized to.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Participants with a previous lower extremity injury occurring to the ankle and/or hindfoot within the previous 12 months AND
  • pain greater than 3 out of 10 on the numeric pain rating scale (NPRS) OR
  • limited weightbearing dorsiflexion range of motion of greater than 2.0 cm side-to-side difference as measured by the ankle lunge test (ALT) OR
  • greater than 3.5% side-to-side difference as assessed by the Y-balance test.

排除标准

  • Operative fixation within the past 3 months to the lower extremity
  • Have received DN of the lower extremity within the past 30 days
  • Current pregnancy
  • Have a history of systemic disorders in which DN would be contraindicated (bleeding disorders or current anticoagulant medication use)
  • Immunocompromised
  • Decline participation

结局指标

主要结局

DN location effect on self-reported and clinical outcomes

时间窗: 2 year

Foot and Ankle Ability Measure (FAAM)

DN location effect on clinical outcomes - Muscle Stiffness

时间窗: 2 year

Muscle Stiffness Measured with the MyotonPro

DN location effect on clinical outcomes - Gait

时间窗: 2 year

Plantar pressure during gait measured by the EMED system and GAITRite

DN location effect on clinical outcomes - Dynamic Balance

时间窗: 2 year

Balance measured by the Y-balance test

DN location effect on clinical outcomes - PPT

时间窗: 2 year

Pain pressure threshold measured by an algometer

次要结局

  • Validation of needle placement in lower extremity muscles(6 month)

研究者

发起方
Regis University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephanie Albin

Principal Investigator

Regis University

研究点 (2)

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