跳至主要内容
临床试验/NCT02249858
NCT02249858已完成不适用

Palpatory and Ultrasound Assessment of Cervical Dysfunctions and the Effect of Cervical High Velocity Low Amplitude (HVLA) Technique

New York Institute of Technology1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2013年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
1
主要终点
Cervical Range of Motion

研究概览

简要总结

Osteopathic medicine is a distinct school of medicine. Osteopathic physicians evaluate the neuromusculoskeletal system and work to achieve normal body mechanics. They use palpation to identify somatic dysfunctions. After performing osteopathic manipulative treatment (OMT), such as high velocity low amplitude (HVLA), a dysfunction is reassessed by palpatory assessment. While there are studies which show the effectiveness of OMT, a challenge remains to objectively assess a somatic dysfunction.

The purpose of this study is to investigate the content validity of the palpatory examination for the cervical spine using ultrasonography and the effects of a single cervical HVLA technique. Content validity is the extent to which a measure adequately and comprehensively measures what it claims to be measuring. The Investigators aim to objectively assess diagnosis and treatment of the cervical spine.

HVLA technique employs a rapid, therapeutic force of brief duration that travels a short distance within the anatomic range of motion of a joint, and that engages the restrictive barrier in one or more planes of motion to elicit release of restriction. It is also known as a thrust technique. The goal of the treatment is the restoration of physiological motion to the dysfunctional joint.

Proper diagnosis of a joint dysfunction is important for spinal manipulation. Little assessment has been made of the clinician's ability to reliably identify a joint with biomechanical dysfunctions. Few studies attempt to address the challenge of evidence-based clinical practice. These have found the benefit of consensus training.

In a study conducted by Shaw et al., ultrasound machine was used to assess the content validity of palpatory examination and objectively assess the effect of HVLA in the lumbar spine. The investigators aim to adapt the protocol for the cervical spine, but with the addition of a control cohort. Subjects will be subjected to the cranial vault hold, which assesses the primary respiratory mechanism in and the degree of participation of each bone in the general motion of the cranium. In the experimental group, participants will be receiving cervical HVLA to the key somatic dysfunction.

The Investigators hypothesize that an ultrasound is a reliable instrument to objectively evaluate somatic dysfunction of the cervical spine. Furthermore, the investigators hypothesize that after performing cervical HVLA, the left and right articular pillars of the key somatic dysfunction vertebrae should be symmetrical compared to baseline.

详细描述

The osteopathic philosophy applies to manipulative treatment as well as viewing an individual as a whole entity. The neuromusculoskeletal system is important to sustaining a healthy life. The musculoskeletal system is intimately connected with all other systems of the body through both the voluntary and involuntary nervous systems. Osteopathic physicians are trained to evaluate the neuromusculoskeletal system and work to achieve normal body mechanics through the use of manual manipulative medicine.

Osteopathic physicians use palpatory examination to identify somatic dysfunctions. The accepted definition in the Glossary of Osteopathic Terminology is: "Somatic dysfunction is an impaired or altered function of related components of the somatic (body framework) system: Skeletal, arthrodial, and myo-fascial structures, and related vascular, lymphatic and neural elements". Physicians assess for texture changes, asymmetry, restriction of motion, and tenderness. After performing OMT, such as HVLA, a dysfunction is reassessed by palpatory assessment once again. While there are studies which show the effectiveness of OMT, a challenge remains to objectively assess a somatic dysfunction.

According to the Glossary of Osteopathic Terminology, HVLA technique is defined as "An osteopathic technique employing a rapid, therapeutic force of brief duration that travels a short distance within the anatomic range of motion of a joint, and that engages the restrictive barrier in one or more planes of motion to elicit release of restriction. It is also known as a thrust technique". The goal of the treatment is the restoration of physiological motion to the dysfunctional joint. In the past, osteopathic manipulation was synonymous with the thrust technique. This may have been because this technique can be taught by accurately describing the nature of the restriction and providing techniques for treating the dysfunction.

Proper diagnosis of a joint dysfunction is important for spinal manipulation. However, little assessment has been made of the clinician's ability to reliably identify a joint with biomechanical dysfunctions. Few studies attempts to address the challenge of evidence-based clinical practice. In a study by Degenhardt et al., investigators looked into the inter-observer reliability of the osteopathic palpatory tests. While the study showed that consensus training did show some improvement in the inter-observer reliability, many previously published studies failed to show a level of reproducibility that supports the use of palpation in evidence-based clinical practice. Najm et al. systematic review paper reasoned that one of the challenges behind evaluating the validity of palpatory assessment is due to the lack of a reference standard measuring means. The reference standard can be used to measure the findings made by palpation.

In a study conducted by Shaw et al. they were able to use an ultrasound machine to assess the content validity of palpatory examination as well as to provide objective evidence of the effect of HVLA on somatic dysfunction in the lumbar spine. We aim to adapt their protocol for the cervical spine. The study conducted by Shaw et al. did not have a control group. In our study, we aim to have a control group which will not be getting treatment in the cervical spine. The control group will be subjected to the cranial vault hold which is generally used to assess the primary respiratory mechanism in the cranium and degree of participation of each bone in the general motion of the cranium. In the experimental group, participants will be receiving cervical HVLA to the key somatic dysfunction segment. Based on Shaw et al. study, we hypothesize that an ultrasound is a reliable instrument to objectively evaluate somatic dysfunction of the cervical spine. Furthermore, we hypothesize that after performing cervical HVLA, the left and right articular pillars of the key somatic dysfunction vertebrae should be symmetrical compared to baseline.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • asymptomatic and healthy participants with not contraindications to HVLA
  • no local metastases
  • no osseous or ligamentous disruption
  • no apprehension on the part of the participant

排除标准

  • contraindications to HVLA
  • diagnosis of fibromyalgia syndrome
  • neck or back or cervical spine pain
  • herniated nucleus pulposus
  • bone diseases (such as osteoporosis)
  • rheumatoid arthritis
  • Down Syndrome
  • prior surgery on back
  • any cervical radiculopathy
  • if rotation of the head and neck causes dizziness, lightheadedness or pain
  • dislocation of the dens associated with rupture or laxity of the transverse ligament of the atlas.
  • advance carotid disease
  • recent history of seizures

结局指标

主要结局

Cervical Range of Motion

时间窗: Change in baseline in cervical range of motion

Measured rotation of the cervical spine

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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