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临床试验/NCT05447338
NCT05447338招募中不适用

Effectiveness of Post Muscle Inhibition Specific Joint Mobilization on Range of Motion and Pain in Patients With Mechanical Neck Pain

Universidad Nacional de Córdoba2 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2021年8月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
114
试验地点
2
主要终点
Degrees of movement

研究概览

简要总结

Neck pain is a common clinical condition of some diseases that affect the soft tissues, musculotendinous structures and joints of the cervical spine. It is characterized by pain in the posterior and lateral muscles of the neck, muscle contractures and partial functional impotence. An important finding is that approximately 60% of total cervical rotation takes place at C1-C2, regardless of age. The test used to diagnose dysfunction of the upper cervical spine is the Cervical Rotation Flexion Test (CRFT) and is measured in degrees through various instruments, the most current validated by scientific literature are mobile applications (Clinometer and Compass ). Having in clear the importance of the location (C1-C2) of the origin of many of the symptoms and signs that cervicalgia generates and mainly the restriction of the range of movement that they produce in the cervical spine. It is that the manual therapy technique: Joint mobilization post muscular inhibition (MAEPI) that is included in this study for its analysis, is directed to this segment of the cervical spine. This differs from other similar techniques, in terms of location and movement of the joint surfaces, which have been previously studied and have shown their effectiveness (techniques that will be used in the control group), in that the micro movements of the joint surfaces ( joint arthrokinematics) based on the principles of Kaltenborn-Evjenth will be combined with the principles of the hold relax technique belonging to the Proprioceptive Neuromuscular Facilitation method. The main therapeutic objective of the MAEPI technique is to improve mobility and reduce pain in the cervical spine.

Hypothesis: The MAEPI technique will improve mobility and reduce neck pain as well as other symptoms associated with neck pain, such as headache, dizziness and nausea, and will be more effective than those of the control group (Maitland central posterior-anterior passive joint mobilization in C2 and natural apophyseal slippage sustained (SNAG) in rotation about Mulligan's C1). The MAEPI technique will be more effective when applied later to myofascial induction techniques.

详细描述

Main goal

-Determine the effectiveness of the MAEPI applied on C1-C2 on the improvement of the range of motion and pain in patients with mechanical neck pain. As well as its effectiveness after performing myofascial induction techniques.

Specific objectives

  • Identify the disability index, the intensity of the pain and the degree of mobility of the patients before and after the application of the proposed treatment protocols.
  • Identify other symptoms associated with neck pain, such as dizziness, headache and nausea before and after the application of treatment protocols.
  • Establish whether there are significant differences in terms of ROM between the proposed protocols, taking into account age, sex, work activity of individuals with neck pain in relation to evolution.

Sample size: The sample size estimate was based on data from previous studies. The standard deviation of 11.1º of the range of motion of the average of the CRFT measurements in patients with upper cervical dysfunction was used. The calculation was performed using the GRANMO sample size calculator (version 7). For an analysis of variance, accepting an alpha risk of 0.05 and a beta risk of less than 0.2 in a unilateral contrast, 38 subjects are needed in each group to detect a minimum difference of 8º between two groups, assuming that there are 3 groups and a deviation 11.1º standard. A rate of loss to follow-up of 10% has been estimated. In the case of repeated paired means by group (experimental group A, MAEPI), accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast, 16 subjects are required to detect a difference equal to or greater than 8 degrees. A standard deviation of 11.1 is assumed. A rate of loss to follow-up of 0% has been estimated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Participant)

盲法说明

The selection of the intervention group will be made by lottery. The participant will not know to which intervention group they will belong, that is, they will be blinded.

入排标准

年龄范围
25 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • You must have a medical indication for cervical physiotherapy.
  • Must present decreased ROM of the upper cervical spine assessed with CRFT, either acute or subacute and of a mechanical type or PN and grade I and II of severity according to The Neck Pain Task Force.

排除标准

  • Joint instability, dislocations, fractures or stenosis of the cervical spinal canal.
  • Malformations and/or bony alterations of the cervical spine or the brain.
  • Head injury or whiplash in the last 10 years. Infections, unhealed wounds, tumors, vascular pathology or cancer that compromises the cervical spine and/or the brain.
  • Being under treatment with anti-inflammatories, muscle relaxants or some type of pain reliever.

结局指标

主要结局

Degrees of movement

时间窗: After the 6 treatment sessions that will be carried out in a period of two weeks for all groups (week 3)

The cervical flexion-rotation test (CFRT) will be measured in degrees of motion. CFRT is effective in evaluating the presence/absence of upper cervical spine dysfunction. If there are symptoms and the range is decreased by more than 10º (normal is 44º on each side), the test is considered positive and, therefore, there is a limitation in the C1-C2 level. The instrument that will be used to measure the rotation of the upper cervical spine in degrees will be the Compass mobile application that has been validated to measure cervical ROM. The goal is to measure the change in range of motion before and after treatment.

次要结局

  • Neck Disability Index(After the 6 treatment sessions that will be carried out in a period of two weeks for all groups (week 3))

研究者

发起方
Universidad Nacional de Córdoba
申办方类型
Other
责任方
Principal Investigator
主要研究者

Franco Catelotti

Principal Investigator

Universidad Nacional de Córdoba

研究点 (2)

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