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临床试验/NCT01855893
NCT01855893已完成不适用

Effectiveness of the Auto-acupressure for Diminishing Neck Pain of Benign Origin

Gerencia de Atención Primaria, Madrid1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2013年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
160
试验地点
1
主要终点
Pain intensity

研究概览

简要总结

The purpose of this study is to evaluate the effectiveness of the auto-acupressure (digital pressure in points of acupuncture) added to the conventional treatment.

详细描述

OBJECTIVE

To evaluate the effectiveness of the digital pressure in points of acupuncture added to the conventional treatment for diminishing the pain in patients with cervicalgia of benign origin.

MATERIAL AND METHODS

Pragmatic controlled randomized clinical trial. Patients with diagnosis of cervicalgia of benign origin will include. They will be randomly assigned to receive just conventional treatment or this plus auto-acupressure.

The professionals will once receive instruction in the Centres of Health by an experienced acupuncture professional that will supervise, in a workshop, the right application of the technique, that will consist of the application of manoeuvres of auto-acupressure by the own patient during periods of 10 minutes, once in a day during one week. The pain intensity will be evaluated by means of a millimetric scale of 10 cm (0 represents the pain absence, 10 the maximum imaginable pain, Numerical Scale Rating). The pain will be measured in the inclusion and days 1, 3, 7, 30 and 90. The sample size has been calculated to detect a minimum difference of 1.5 points (DS 2) in the scale of the pain in day 7, which implies the recruitment of, at least, 80 patients by group (if losses don't exceed 20%). Also the perception of the quality of life (euroQol-5D) and the functional capacity with the scale of Oswestry will be evaluated, at the beginning, and days 3, 7, 30 and 90. The measures in each point between the group will be compared control and intervention. The evolution of the repeated measures will compare between groups with a generalized estimating equation (GEE) model.

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
None

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

  • Patients who come to consultation of Primary Care for neck pain without structural hurt or irradiation, with muscular contraction and functional and postural limitation.

排除标准

  • Injuries of skin (dermatitis, burns, sores, skin cancer) in the zone to massaging
  • Structural injuries (bony fractures or injuries of muscles and tendons) in the zone to massaging
  • Hemorrhage or tendency to suffer hemorrhage
  • Chronic, serious diseases
  • Malignant diseases and marked physical deterioration
  • Psychiatric disorders
  • Sensitive alterations
  • Treatment with drugs of second or third level of the scale of the WHO which difficult to estimate changes for auto-acupressure
  • No sign the informed consent
  • Difficulty of reading comprehension or visual alterations

结局指标

主要结局

Pain intensity

时间窗: Ninety days

The pain intensity will be evaluated by means of a millimetric scale of 10 cm (Numerical Rating Scale)

次要结局

  • Perception of quality of life(Ninety days)

研究者

发起方
Gerencia de Atención Primaria, Madrid
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Susana Calvo Trujillo

PhD

Gerencia de Atención Primaria, Madrid

研究点 (1)

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