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临床试验/NCT03044106
NCT03044106已完成不适用

The Effects of Cranial Laser Reflex Technique on Hamstring Flexibility, Strength, and Pain Pressure Threshold: a Pilot Study

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2017年3月4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
44
试验地点
2
主要终点
90-90 Knee Extension Angle Test

研究概览

简要总结

Purpose: To conduct a pilot study of the effect of Cranial Laser Reflex Technique (CLRT) compared with sham laser on hamstring muscle flexibility, strength, and pain pressure threshold.

Participants: Active, young adults ages 18 to 35.

Procedures: A two-visit, assessor and participant-blinded crossover study with 1-week washout. Subjects will complete three functional hamstring tests before and after CLRT and sham laser treatment. Subjects will also complete questionnaires to assess their expectations and perceptions of the interventions.

详细描述

First Visit: Subjects who met the inclusion criteria and gave consent completed a brief questionnaire on their activity level, history of hamstring injuries, and perceived hamstring tightness and were randomized to one of the following for the first treatment period: 1) active CLRT; or 2) sham laser.

After randomization, subjects were asked to complete the three functional hamstring tests: 90-90 Knee Extension Angle (KEA) to assess flexibility, handheld dynamometry (HHD) for strength, and pain pressure threshold (PPT).

Assessments. KEA: The 90-90 Knee Extension Angle test is a functional assessment designed to assess lower extremity flexibility and is considered the gold standard for hamstring length. The participant began in the supine position on a treatment table. The tested extremity (the right leg in each subject) was placed in a 90° hip and 90° knee position with the contralateral lower extremity placed flat on the table. A digital inclinometer was consistently placed at the level of the medial malleoli and the superior pole of the patella. The examiner maintained 90° of hip flexion. Pelvic position was monitored by palpation of the anterior superior iliac spine and lumbar spinous processes to maintain a neutral pelvic position. The examiner passively extended the knee to the point of a ''strong, but tolerable stretch," as reported by the subject. The examiner read the angle of the inclinometer and recorded the mean value of three attempts. A greater angle indicates greater degree of flexibility.

Hand held Dynamometry (HHD) is currently considered a reliable and valid measurement of peak muscle contraction. The subject began prone on the table with right leg bent to 90°. The tester placed the dynamometer (microFET2; Hoggan Health Industries, Salt Lake City, UT) at the heel of the participant and applied force to the heel, gradually increasing in 3 to 5 seconds. Participants was instructed to resist the applied force and maximally contract the hamstring muscle against the HHD device. The test ended once they are no longer able to resist the force and the leg begins to move (break point). The investigator recorded the mean value of three attempts.

Pain Pressure Threshold (PPT) is a reliable, accurate and valid method for measuring muscle pain sensitivity and response to treatment. The digital algometer (FDX, Wagner Instruments, Greenwich, CT) is a hand-held muscle tester with a range of 0-100 lbf that consists of a padded disc with a diameter of 0.5" attached to a microprocessor-control unit that measures peak force (pounds or kilograms). The unit has a digital readout for peak-applied pressure and provides a built-in calibration routine that verifies a valid calibration. In order to determine PPT, the researcher applied the tip of the algometer to a tender spot in the participant's hamstrings and increased the amount of pressure until the participant verbally informed the researcher when the sensation of pressure became pain. At this point the algometer was removed and the peak force recorded. The mean of three repeated measures was reported.

研究设计

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

盲法说明

Subjects and assessors were blinded to treatment allocation. The subject was face down, eyes closed, and wearing protective eyewear that blocks the specific wavelength of the laser light during the intervention.

After each treatment session, the participants completed a de-blinding questionnaire administrated by the assessor providing a dichotomous 'yes' or 'no' answer as to whether active treatment was received. This response was followed by a second question regarding how certain they were that active treatment was received on a 0-10 numeric rating scale (NRS), where 0 represents absolutely uncertain and 10 represents absolutely certain.

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Between 18-35 years of age
  • All genders
  • Willing to complete two study visits over 2-3 weeks
  • Able to read and communicate in English

排除标准

  • Current lower back condition with pain, numbness or tingling that radiates down the legs
  • Active treatment for a major medical illness, such as heart disease, uncontrolled diabetes or hypertension, malignancy, autoimmune, or immune deficiency disorder
  • History of vasculitis, intracranial mass, clotting disorder (including medication-induced, e.g., warfarin)
  • Current skin malignancy on scalp
  • Cognitive dysfunction preventing informed consent
  • Pending or currently receiving benefits from personal injury litigation, including worker's compensation
  • Chronic long-term disability related to lumbosacral injury/symptoms

研究组 & 干预措施

CLRT, Then Sham

Active Comparator

Subjects performed the KEA, HHD, PPT functional tests on their right hamstring before and after the CLRT intervention.

干预措施: CLRT (Device)

Sham, Then CLRT

Sham Comparator

The Sham procedure was identical to CLRT except the laser device was placed in placebo mode: all device indicator lights and sounds will be functional but no laser light will be emitted from probe aperture.

干预措施: CLRT (Device)

结局指标

主要结局

90-90 Knee Extension Angle Test

时间窗: At baseline and immediately after intervention

Knee Extension Angle (KEA) test is a functional test designed to assess lower extremity flexibility and is considered the gold standard test for assessing hamstring length. Results will be recorded as degrees of knee flexion angle. A clinically significant effect size is an increase of 5 degrees.

次要结局

  • Handheld Dynamometry(At baseline and immediately after intervention)
  • Pain Pressure Threshold(At baseline and immediately after intervention)
  • Mean Difference Pre/Post KEA, Stratified by History of Prior Hamstring Strain(At baseline and immediately after intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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