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Assessing Tissue Response to High-Velocity Thrust Manipulations on Capsule Length and Stiffness at the C5-C6 Facet Joint Capsule

2026年8月24日 更新者:Florida Gulf Coast University

Assessing Tissue Response to High-Velocity Thrust Manipulations: Measuring Lasting Changes in C5-C6 Facet Joint Capsule Length With Musculoskeletal Ultrasound and Stiffness With Elastography

This study is a quasi-experimental study collected quantitative data , with a pre-test-post-test design. Pre-intervention, baseline measurements of C5-C6 right facet joint length and width with the head of the treatment plinth downward at 45 and 90 degrees, (relative to the rest of the table) and stiffness at 90 degrees, were taken prior to applying the long-axis thrust manipulation. Post-intervention measures were taken immediately after a long axis thrust manipulation of C5-C6 and again at 24-hours after the manipulation. The baseline pre-intervention measures were then compared to the post-intervention measurements. The investigator performing the manipulation was blinded to the quantitative measurements of the ultrasound images. The ultrasound operator was blinded to the outcome of the manipulation.

研究概览

详细说明

The study takes place in Marieb Hall rooms 101 and 103 of Florida Gulf Coast University. After meeting the inclusion and exclusion criteria subjects sign the informed consent form described thoroughly on the following page. The participants undergo three recording sessions on two consecutive days. The first recording session consist of obtaining participant consent and general information, such as height and weight. The participants then has their baseline measures cervical flexion ROM, capsular length and width at both 45 and 90 degrees, and stiffness at 90 degrees, taken. The second and third session consist only of repeating these baseline measures post-manipulation and 24-hours post-manipulation respectively. Each participant will be provided a profile on the ultrasound unit, corresponding to their subject number, with each point in time having an individual exam within the profile. At these sessions, recordings are done in the prone position to measure length of the C5-C6 joint capsule and joint capsule tissue extensibility. Locating the articular pillar was a three-fold process. At the intervention table, the C7 spinous process is identified in upright sitting with palpation, due to its relevance in clinical examination and evaluation, serving as the first landmark. From this position, one of the measuring practitioners moves their finger cranially to the C6 spinous process. The participant's head is moved passively into extension, causing the spinous process to move away from the practitioner's finger, providing further confidence in location accurary. This landmark isthen marked for repeatability. The participant then has their cervical flexion range of motion measured with a fluid-filled inclinometer. A fluid-filled inclinometer utilizes gravity to quantify gross motion. This method is easily repeated and validated for clinical measurements. Each participant is given the instructions, "sit up straight and tuck your chin to your chest." At the ultrasound table, a goniometer is secured with the stationary arm in line with the table, the axis through the pivot point for the head of the table, and the moving line in line with the head of the table.

The participant is then instructed to lie prone on the table, with the head of the table positioned at 45 degrees. Anytime the head position of the table is altered, two researchers confirmed the angle of the goniometer. The 45 degree angle was selected to neutralize the natural lordosis of the lower cervical spine. The table insert is removed for the participant's face to lie within the opening. A piece of tape is placed at the base of the table opening . The participants are given the instructions, "tuck your chin and put the front of your chin on the piece of tape." From this point, the ultrasound probe is placed in a right paramedian sagittal/long-axis view. The probe was angled 15 degrees from lateral-to-medial in the posterior-to-anterior direction.

Beginning at the occipital bone, the probe is moved inferiorly. The articular pillar is known to have a jagged, sawtooth like appearance when observed from this angle. The trough at the bottom of the sawtooth indicates the inferior articular process of the cranial vertebra, while the following peak will be depicting the superior articular process of the following caudal vertebra.

This allowed the practitioners to count the peaks observed and identify the spinal levels visualized on the screen. The mark placed on the C6 spinous process is compared to probe location once the C6 level has been visualized on the screen. After the level is confirmed to be correct, the probe remained stationary on the participant. Once the correct level is visualized, the first screen capture video was taken and saved to the participant exam. The head of the table is then angled fully down towards the floor, measured at 90 degrees with the secured goniometer. By having the head of the table as far down as it allows, the process for achieving full cervical flexion remained standardized. This is also confirmed via palpation of the interspinous space of T1 and by both practitioners audibly confirming the observation of the thoracic spine flexion, indicating full cervical flexion is achieved. While the capsule could theoretically be put under more tension by utilizing multiplanar movements, utilizing only flexion offers a standardized, repeatable method that is less susceptible to confounding variables. As the probe remains stationary with the C5-C6 joint in view, the second screen capture video is taken. While remaining in the fully flexed position, the ultrasound operator start the elastography on the ultrasound unit. Once displayed on screen, a third screen capture video is taken.

The participant then returns to the initial table to receive the intervention. The practitioner performing the HVLA long axis C6-C6 manipulation on the right stands at the head of the plinth, on the right side of the patient positioned in supine. The practitioner's right hand is placed under C6, while the left hand is placed under the chin as the arm cradles the head. Using the left hand and arm, the practitioner passively rotated the head away and side-bent the head toward the targeted side. Once end-range motion is achieved, the practitioner provides a high-velocity low-amplitude long-axis thrust in a superior direction, parallel to the angle of the targeted segment.

Following the manipulation, the participant has their cervical range of motion re-measured, and the ultrasound imaging process is repeated in a new exam. Once the immediate post-intervention measures are taken, the subjects are instructed to come back for a third imaging session at the exact same time the following day. At the 24-hour follow-up, the participants cervical flexion range of motion is repeated, as well as the three ultrasound procedures.

研究类型

介入性

注册 (实际的)

42

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Florida
      • Fort Myers、Florida、美国、33965
        • Florida Gulf Coast University Marieb Hall 101

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

是的

描述

Inclusion Criteria:

  • Healthy individuals between 18-35 without neck pain
  • Able to to read and understand English

Exclusion Criteria:

  • autoimmune disease
  • down syndrome
  • fusion, fracture
  • spinal cord compression
  • vascular pathology
  • cancer,
  • any other conditions that induce severe instability
  • inflammation
  • weakened bone.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Sample
C5-C6 long axis joint manipulation
Long axis trust manipulation C5-C6

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
facet capsule length and width
大体时间:before intervention, immediately after, and at 24 hour follow up
MSK US measure facet length and with in mm
before intervention, immediately after, and at 24 hour follow up

次要结果测量

结果测量
措施说明
大体时间
Cervical motion
大体时间:before intervention, immediately after, and at 24 hour follow up
Max neck flexion motion in sitting measured in degrees
before intervention, immediately after, and at 24 hour follow up
elastography
大体时间:Before intervention, immediately after, and 24 hours after
tissue pliability assessment with MSK US
Before intervention, immediately after, and 24 hours after

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

  • 1. Hurwitz EL, Randhawa K, Yu H, Cote P, Haldeman S. The global spine care initiative: a summary of the global burden of low back and neck pain studies. Euro Spine Journ. 2018;27(1):796-801. 2. Brown S. Distracted doctoring. Springer Cham; 2017 3. Herzog W. The biomechanics of spinal manipulation. Journ Body and Move Ther. 2010;14(3):280-286. https://doi.org/10.1016/j.jbmt.2010.03.004 4. Olson KA. Manual Physical Therapy of the Spine. Elsevier - Health Science; 2021. 5. Pettman E. A history of manipulative therapy. Journ of Man & Manip Ther. 2007;15(3):165-174. https://doi.org/10.1179/106698107790819873 6. Giacalone A, Febbi M, Magnifica F, Ruberti E. The effect of high velocity low amplitude cervical manipulations on the musculoskeletal system: literature review. Cureus. 2020;12(4). doi: 10.7759/cureus.7682 7. Young IA, Pozzi F, Dunning J, Linkonis R, Michener LA. Immediate and short-term effects of thoracic spine manipulation in patients with cervical radiculopathy: a randomized controlled trial. JOSPT. 2019;49(5):299-309. doi: 10.2519/jospt.2019.8150 8. Reggars JW. The manipulative crack. Journ Chiro Osteo Coll of Aust. 1996;5(2):39-44. doi: 9. Manning A, Butts R, Dunning J. Audible pop during spinal manipulation: plausible mechanisms and clinical relevance. AAMT. June 21, 2016. Accessed October 14, 2024. https://spinalmanipulation.org/2016/06/21/audible-popping-during-spinal-manipulation-plausible-mechanisms-and-clinical-relevance/ 10. Moorman AC. Impact of audible pops associated with spinal manipulation on perceived pain; a systematic review. Chiro and Manual Ther. 2022;30(1). https://doi.org/10.1186/s12998-022-00454-0 11. Smith J, Finnoff JT. Diagnostic and interventional musculoskeletal ultrasound: Part 1. fundamentals. PM&R. 2009;1(1):64-75. https://doi.org/10.1016/j.pmrj.2008.09.001 12. Moreno B, Barbosa J. Ultrasound-guided procedures in the cervical spine. Cureus. 2021. https://doi.org/10.7759/cureus.20361 13. Vasiliadis ES, Grivas TB, Kaspiris A. Histo

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年2月4日

初级完成 (实际的)

2026年6月1日

研究完成 (实际的)

2026年8月1日

研究注册日期

首次提交

2026年7月10日

首先提交符合 QC 标准的

2026年7月10日

首次发布 (实际的)

2026年7月15日

研究记录更新

最后更新发布 (实际的)

2026年8月25日

上次提交的符合 QC 标准的更新

2026年8月24日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2025-10 (Istanbul Medipol University Scientific Research Projects Commission)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

only unidentifiable data will be shared.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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