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临床试验/NCT03322683
NCT03322683已完成不适用

Vacuum Myofascial Therapy Device for Non-specific Neck Pain. A Single Blind Randomized Clinical Trial

University of Cadiz2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2018年7月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
2
主要终点
The intensity of cervical pain

研究概览

简要总结

This study aim to investigate the effects of physium therapy for improving pressure pain thresholds (PPTs), range of motion,Neck Disability Index, the multidimensional health related quality of life (SF-12) and the multidimensional health related quality of life and pain in patients with mechanical neck pain (NP).

详细描述

Fifty-four participants with NP will randomly allocated to either an physium therapy (five sessions) or a physical therapy (PT) groups (ten sessions) during two weeks. Multimodal PT program included: ultrasound therapy (US), transcutaneous electric nerve stimulation (TENS) and massage. Visual Analogue Scale (VAS), Neck Disability Index ( NDI), range of motion and (CROM), Questionnaire SF-12 and PPTs in sub-occipital and upper trapezius muscles were measured at baseline, at the end of treatment and at 1 month follow-up. T-tests and a repeated-measures multivariate analysis of variance (RM-MANOVA) were used for VAS, CROM and PPTs, respectively.

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
Single (Investigator)

盲法说明

Blind researcher

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of both sexes,
  • Aged between 20 and 60 years, in an
  • Active state of pain and diagnosed with a month of evolution.

排除标准

  • Patients who are pregnant, have pacemaker and those Surgically operated cervical spine - - Patients who have been treated with myofascial therapy a month earlier.

结局指标

主要结局

The intensity of cervical pain

时间窗: Baseline

A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of cervical pain, and the worst and lowest level of pain experienced in the preceding week in the cervical area.

次要结局

  • The multidimensional health related quality of life(Baseline and four weeks)
  • The intensity of cervical pain(Four weeks)
  • Active cervical range of motion(Baseline and four weeks.)
  • Pressure pain thresholds in cervical trigger points(Baseline and four weeks)
  • This questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life.(Baseline and four weeks.)

研究者

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

Manuel Rodriguez Huguet

Clinical professor

University of Cadiz

研究点 (2)

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