Evaluation of the Effect of Acupuncture on Hand Pain, Functional Deficits and Health Related Quality of Life in Patients With Rheumatoid Arthritis - A Multicenter, Double-blinded, Randomised Clinical Trial
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Quality of life (Assessment by SF-36 scale)
研究概览
简要总结
Rheumatoid Arthritis (RA) is a systemic inflammatory disease characterized by functional disability and pain. Although acupuncture is widely used, western acupuncture studies on RA show no conclusive positive result. Acupuncture is regarded as a reflex therapy, and Traditional Chinese Medicine (TCM) diagnosis was shown to be an individual neurovegetative state allowing to individually allocated acupoints. Positive results were reported using a classical diagnostic procedure to allocate acupoints to the patient according to the Shang Han Lun. The investigators are interested if acupuncture compatible with this ancient theory would be successful in improve hand function in RA patients.
The investigators therefore developed a prospective randomized control trial in a three-armed parallel group design with a standardized treatment intervention. Only patients with the TCM diagnosis of a so-called Turning Point syndrome will be allowed in the experimental phase. This may harmonize TCM diagnosis and the standardized intervention, in order to optimize potential therapeutic effects.
详细描述
The study design is divided into two parts. First the investigators will follow a non-experimental nature design. Based on the results of this exploratory study we will then start a three-armed parallel-group study with equal randomization (1:1:1), prospective, double-blind, placebo-controlled and multicenter that will be conducted in Portugal (2 sites).
We plan to include 381 patients with RA of the hands in accordance to the selection criteria. The patients are going to be recruited from the national centers of rheumatology and patient associations in the time from May 2015 to October 2016. All patients are supposed to sign an informed consent at the time of enrollment according to the rules of the Helsinki Declaration.
Task 1 In the first task we are going to develop a non-experimental, exploratory and descriptive nature design with the goal to describe the epidemiological, clinical and genetic profile of patients with RA of the hands according to their TCM diagnosis.
We will use an individual instrument for the collection of data to characterize the patients socio-demographically and clinically.
The main characteristics, complaints and objective examinations of participants, will be characterized by a qualified and experienced acupuncturist (first physician), in accordance to the Heidelberg Model (HM) to TCM. This physician will assess the pain in the hand by using a pressure algometer in two different distinct points. It is well known that the lower the ability to tolerate the pressure is, the worse will be the individual pain. The same researcher will also record clinical features based on data from tongue-diagnosis that will have been conducted before by an Automatic Tongue Diagnosis System (ATDS). The results so far demonstrate that the ATDS is very consistent even in settings with different environmental lighting.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Compliance inform consent
- •Patients with RA
- •Fulfill The ACR criteria of RA
- •Impairment of the hand strength with or without pain in the hands during the grip procedure
- •Chronic pain: either persistent or intermittent over a minimum period of three months prior to recruitment
- •Current pain: greater than 30/ 100 mm on a pain visual analogue scale (VAS) within the last 24 hours despite medication
- •Patients on stable dose treatment for at least 3 weeks
排除标准
- •Under the age of 18 years
- •Previously had acupuncture
- •Localized skin infections
- •Severe chronic or uncontrolled co-morbid disease
- •The wish to get a pension.
结局指标
主要结局
Quality of life (Assessment by SF-36 scale)
时间窗: up to 19 months
Assessment by SF-36 scale
gene expression profiles (Assessment by microarray)
时间窗: up to 19 months
Assessment by microarray
次要结局
- hand pain (Assessment by algometry)(up to 19 months)
- hand strength (Assessment by dynamometry)(up to 19 months)
- Interleucines levels in blood(up to 12 months)
- Cortisol levels in blood(up to 12 months)
研究者
Susana Seca
Principal Investigator
University of Coimbra