The Effect of Combination of Massage and Electroacupuncture in Patients with Chronic Lumbar Pain. Comparison with the Use of Epidural Analgesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Assessment of pain intensity: NRS
研究概览
简要总结
The aim of this study is to evaluate and compare in patients with chronic back pain two therapeutic interventions: a) the combination of massage and electroacupuncture; and b) the application of epidural analgesia in pain, functioning-incompetence, quality of life and mood.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from lumbar pain of benign etiology
- •Age 20 to 65 years
排除标准
- •Ages over 65 or below 20 years
- •Neoplasms (benign or malignant etiology)
- •Contagious or infectious disease
- •Dermopathy
- •Pregnancy
- •Alcohol or drug use
- •Previous use of epidural analgesia
- •Systemic opioid use
- •Severe heart disease
- •Fever for more than one sessions
- •Allergy to the oil which will be used and its derivatives
- •Thrombi or varicose veins
- •Psychiatric disease
研究组 & 干预措施
massage-electroacupuncture
Electroacupuncture will be applied throughout the back of the body, upper limbs and ears.Massage will follow the same paths of acupuncture points respectively
干预措施: Electroacupuncture device (Device)
Epidural analgesia
Epidural analgesia will be applied using lidocaine 2%, 1.5 ml, and Dexamethasone 8 mg
干预措施: Epidural analgesia (Drug)
结局指标
主要结局
Assessment of pain intensity: NRS
时间窗: 2 years
The Numeric Rating Scale will be used to evaluate the pain. The Numeric Pain Rating Scale is a segmented numeric version of the Visual Analog Scale in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain (0 - no pain, 10 - worst pain).
Assessment of functional status and incompetence in both groups
时间窗: 2 years
The Oswestry \& Roland-Morris Disability Questionnaire (specific for low-back pain) will be used to assess patient functional status and incompetence
Measurement of health-related quality of life
时间窗: 2 years
The SF-36 Health Survey questionnaire will be used. It is a generic measure of health status as opposed to one that targets a specific age, disease, or treatment group. It has three levels: (1) items; (2) eight scales that aggregate 2-10 items each; and (3) two summary measures that aggregate scales. Each item is used in scoring only one scale. Three scales (Physical Functioning, Role-Physical, Bodily Pain) correlate most highly with the physical component and contribute most to the scoring of the Physical Component Summary measure. The mental component correlates most highly with the Mental Health, Role-Emotional, and Social Functioning scales, which also contribute most to the scoring of the Mental Component Summary measure. Three of the scales (Vitality, General Health, and Social Functioning) have noteworthy correlations with both components. The SF-36 has a verbatim content and response choices.
Profile of mood states
时间窗: 2 years
The The Profile of Mood States (acronym: POMS) is a standard validated psychological test. This questionnaire will be used to investigate the mood level. It is a questionnaire investigating the mood level and assessing the impact of a program on the patient mood in the short term. The questionnaire consists of 72 adjectives related to mood, which are grouped into 6 factors. The first five factors are negatively rated (high scores correspond to more negative emotions). The sixth factor is scored positively (high scores correspond to higher vitality). Participants are asked to complete these adjectives in a 5-point Likert-type scale ranging from "not at all" (0) to "extremely" (4).
次要结局
未报告次要终点
研究者
Elena Arnaoutoglou
Professor of Anesthesiology
University of Thessaly