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临床试验/NCT02498704
NCT02498704已完成不适用

The Effectiveness of Dry Needling and Stretching vs. Stretching Alone on Hamstring Flexibility in Patients With Knee Pain: A Randomized Controlled Trial

Keller Army Community Hospital1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2014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
状态
已完成
入组人数
39
试验地点
1
主要终点
Knee extension range of motion

研究概览

简要总结

The purposes of this double-blinded, randomized controlled trial are (1) to determine if the addition of trigger point dry needling (TDN) to a standard stretching program results in greater improvements in hamstring flexibility versus stretching alone in a population with atraumatic knee pain; (2) measure length of time that flexibility gains are maintained, (3) assess resulting movement mechanics and (4) assess patient reported changes in pain. Findings will potentially lead to insights as to the benefit of applying this intervention to additional body regions.

详细描述

In this study, up to 40 subjects with a history of atraumatic knee pain will be randomized into 2 groups of up to 20 subjects per group (1 experimental group and 1 control group). Subjects in the experimental group will receive TDN intervention with hamstring stretching while subjects in the control group will receive an alternative needling intervention with hamstring stretching. After meeting all inclusion criteria, all subjects will undergo the following tests: supine active knee extension, the active straight leg raise test, deep squat, and a single leg step down from a 6 inch step. Subjects who measure less than 20° from full extension on the active knee extension test will be excluded. Hamstring tightness has been operationally defined as having greater than 20° loss of knee extension as measured with the femur held at 90° of hip flexion.[1] Manual palpation of the bilateral biceps femoris, semitendinosus, and semimembranosus will be performed to detect the presence of myofascial trigger points (TPs) in groups 1 and 2. Dry needling will be performed to all detected TPs by a provider trained and experienced in TDN. Post TDN, all tests will be immediately repeated and at each follow up the subject will complete the Global Rating of Change survey (GROC) and Lower Extremity Functional Scale (LEFS).

Post intervention, subjects in experimental group 1 will be given a standing hamstring stretch to perform 1 repetition held for 30 seconds, repeated 3 times daily. These parameters have been shown to be effective at improving flexibility.[2] Subjects will be instructed by demonstration and will be provided with a handout of stretching instructions. Subjects will be given an exercise log to record home exercise compliance.

Subjects in group 2 will be given an alternative needling intervention followed by a standing hamstring stretch to perform 3 times per day, 1 repetition held for 30 seconds. Alternative needling intervention will be performed to give the appearance of regular TDN intervention; however, no needle penetration will be performed. Following alternative needling intervention, subjects will be instructed by demonstration and will be provided with a handout of hamstring stretching instructions. Home exercise compliance will be recorded at each follow up.

Follow up measurements will be recorded between 1-2 days, 3-4 days, and 7-8 days post intervention. All tests will be repeated. One additional session of TDN and alternative needling intervention will be performed at day 3-4.

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, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Department of Defense healthcare beneficiaries
  • •18-40 years old
  • •atraumatic knee pain greater than 2 weeks in duration
  • •Lack of 20 degrees or more of active supine knee extension

排除标准

  • •History of herniated lumbar disc/radiculopathy
  • •Prior surgery in the hip, knee or back
  • •Self-Reported Pregnancy
  • •History of blood borne pathogens/infectious disease/active infection/metal allergy
  • •Knee pain of traumatic origin, instability, joint line tenderness, or positive meniscal tests
  • •Participants who are not fluent in English
  • •Previous history of TDN
  • •Bleeding disorders or currently taking anti-coagulant medications

研究组 & 干预措施

Sham Needling intervention, Control

Sham Comparator

Sham dry needling, group does not receive true dry needling intervention.

干预措施: Sham Needling (Other)

Dry Needling Intervention, experimental

Experimental

Group receives true dry needling intervention.

干预措施: Dry Needling (Procedure)

结局指标

主要结局

Knee extension range of motion

时间窗: 7-8 days

Assessed with active supine knee extension and supine straight leg raise using digital inclinometer

次要结局

  • knee pain with squat recorded on visual analog scale(7-8 days)
  • knee pain with step down test recorded on visual analog scale(7-8 days)
  • lower extremity functional scale (LEFS)(7-8 days)
  • knee range of motion during squat(7-8 days)
  • Global Rating of Change(7-8 days)

研究者

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

John Mason

Sports Physical Therapy Fellow

Keller Army Community Hospital

研究点 (1)

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