Effectiveness of the Auto-acupressure for Diminishing Neck Pain of Benign Origin
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
- 否
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
Susana Calvo Trujillo
PhD
Gerencia de Atención Primaria, Madrid
