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临床试验/NCT04059692
NCT04059692已完成不适用

Immediate Effect of a Single Cervical Spinal Manipulation on Cervical Movement Pattern

University of Valencia1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年9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
50
试验地点
1
主要终点
Range of motion

研究概览

简要总结

Objective: The aim of the present study is to analyze the immediate effect of a single cervical spinal manipulation on cervical movement pattern. Further, To perform the sample size calculation, the investigators took into consideration that the investigators pretend to achieve a medium effect size (d=0.5) of the differences with two groups (EG and CG) and two aimed to explore the impact on pain, disability and patient's improvement-perceived sensation, comparing with a placebo.

Methods: The study design is experimental and purposive sampling was used to select the study participants. The grouping allocation was randomized. The people volunteer to participate in the study, are assigned to the experimental group (EG) that will receive a single manipulation, to the control group (CG) that will receive a single placebo treatment.

The participants will be assessed twice, one before the treatment and the other, after the end. Head movement is recorded by means of a video-photogrammetry system from the coordinates of a set of eight reflective markers located on a helmet. The movements will be record at 200 fps.

In each evaluation, the perceived pain and the neck disability index are also recorded. And the impression of change is evaluated only in the second evaluation.

Outcomes. Pain, Disability of the neck, Impression of Change, Range of motion (RoM), Maximum angular velocity (MAV), Maximum angular acceleration (MAA) and Harmonicity (HARM).

Intervention: The intervention, in both groups, it includes only one session that lasted 15 minutes approximately: a) Cervical manipulation intervention and b)Placebo intervention.

详细描述

INTRODUCTION Non-specific neck pain is defined as pain in the posterior and lateral aspect of the neck between the superior nuchal line and the spinous process of the first thoracic vertebra with no signs or symptoms of major structural pathology. It is a common musculoskeletal disorder that leads to substantial disability, discomfort, and reduced cervical mobility, resulting in enormous health costs in terms of treatment and work absenteeism. The American Physical Therapy Association's guidelines on neck pain recommends utilizing cervical manipulation (CM) and mobilization procedures to reduce neck pain based on strong evidence. Spinal manipulation is defined as "a passive, high velocity, low amplitude thrust applied to a joint complex within its anatomical limit with the intent to restore optimal motion, function, and/or to reduce pain" and its effectiveness, concretely of a continuous program of cervical manipulations (CM), on neck pain has been largely studied. A previous systematic review concluded that treatments based on CM are effective both alone and in combination with exercises whilst other systematic reviews and an evidence-based guideline showed that CM, combined with exercises, resulted to be more effective for neck pain, function, and global perceived effect, than a therapeutic program based, exclusively, on CM.

Nevertheless, the underlying mechanisms of the pain decrease with this therapeutic approach are not completely understood. A recent study aimed at analyzing the biomechanics of a single CM, used a complex system of synchronized biplane radiographs to measure the facet gapping during a single manipulation. Authors demonstrated that target and adjacent motion segments undergo facet joint gapping during a manipulation and that segmental and global range of motion (ROM) increases in all three planes of motion immediately after one manipulation.

In the clinical setting, the best of our knowledge, only one previous clinical trial have analyzed the effectiveness of a single cervical manipulation on cervical range of motion, comparing with placebo, demonstrating an improvement in all the global maximum cervical movements, measured with the goniometer. However, pain may affect other movement' characteristics beside the maximum range of motion (ROM), as velocity, variability or movement harmony.

Nevertheless, no previous study has analyzed the characteristics of the patients' cervical motion pattern after a single manipulation which could provide information about functional changes in cervical movements. People with neck pain, has shown more slow movements, less harmonic movements in the points close to pain and exponential trend at the ends of the range, even when cervical spine motion ranges remain within normal limits.

The investigators hypothesized that functional assessment of the cervical spine based on the analysis of the motion pattern, will let us know if a single manipulation is effective in the improvement of those variables.

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)

盲法说明

The subjects do not know the group to which they belong. The evaluator does not know the treatment applied.

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Perceived pain scored 3 or above, in a visual analogue scale
  • •Neck functional status revealing a mild disability
  • •Minimun duration of the symptoms being one month.

排除标准

  • •inflammatory rheumatic disease or an inner ear disorder.
  • •the use of antidepressant opioid or sedative drugs.
  • •current vertigo or dizziness.
  • •visual loss.
  • •neurological disorder,
  • •trunk or shoulder surgery within the past year.

研究组 & 干预措施

Cervical manipulation intervention

Experimental

To perform the evaluation and detect the cervical vertebral level with mobility restriction, with the patient in supine position, a cervical examination is carried out to determine the mobility restriction, both in flexo-extension, as in inclination and rotation. To check the level of restriction, the post-anterior sliding test is performed.

The manipulation is performed following the criteria of thrust manipulations. A maximum of 3 manipulations are applied in total per subject, one for each level (high level C1-C2, medium level C3-C6, and low level C7), if necessary.

干预措施: Placebo intervention (Other)

Placebo intervention

Placebo Comparator

This group will receive 15 minutes of sham techniques in a supine position over the stretcher. First, a series of short-time and no pressure contact with physiotherapist´s hands is performed in several points of head and shoulders for 10 minutes. Subsequently, light touch is applied on standardized anatomic areas, for 2 minutes each time.

干预措施: Cervical manipulation intervention (Other)

结局指标

主要结局

Range of motion

时间窗: 1 day

Angular excursion of the cervical motion.

Harmonicity

时间窗: 1 day

Is the absolute value of the correlation coefficient between: Ӫ and Ө. Thus Harmonicity quantifies the fit between the actual movement and the simple harmonic motion.

次要结局

  • Disability of the neck(1 day)
  • Impression of Change(1 day)

研究者

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

GEMMA V ESPÍ LÓPEZ, PhD

Principal Investigator

University of Valencia

研究点 (1)

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