Effects of Acupuncture on Pain and Quality of Life of People Affected With Chronic Widespread Pain. Study Protocol for a Randomized, Triple-blinded, Placebo Controlled Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Pain will be assessed using the Visual Analogue Scale (VAS).
研究概览
简要总结
Background: Chronic Widespread Pain (CWP) is a multidimensional disorder for which treatment as yet remains unsatisfactory. Acupuncture is one of the most sought therapeutic methods when it comes to alternative medicine, due to its minimal adverse effects and its ease of use in clinical practice. Currently, acupuncture is successfully used in China for the treatment of many chronic diseases. The work to be carried out aims to assess the effects of acupuncture on pain management and quality of life of people suffering from CWP.
Methods/design: The study is a single-center, controlled triple-blind prospective study. A total of 100 participants will be randomly distributed into two groups, the intervention group, which will receive an individualized acupuncture treatment; and control group, which will receive sham acupuncture. The treatments performed will be personalized and the treatment criteria will be based on the use of the Yuan and Luo points. They will be evaluated using a specific measurement system, constituted of the Visual Analogue Scale, The Fibromyalgia Impact Questionnaire and The Medical Outcomes Study Sleep Scale. The primary outcome measures assess whether acupuncture can bring about a decrease in pain and an improvement in the quality of life of people suffering from chronic widespread pain; the secondary outcomes assess whether the use of acupuncture leads to improved sleep quality. The results obtained will be analysed at 1st, 4th and 8th weeks from the start of treatment.
Discussion: This technique is aimed to restore some of the imbalances suffered by patients affected with CWP and to improve their symptomatology. We expect to observe a significant improvement in the pain, quality of life and sleep quality of people affected with CWP. The study will be conducted according to the STRICTA guidelines, which lay down the right way to proceed when carrying out scientific studies in the field of acupuncture.
详细描述
Chronic Widespread Pain (CWP) is defined as spinal pain that lasts at least three months involving both the right and left side of the body, above and below the waist.
CWP is a highly prevalent condition. According to Clauw et al., it affects 10-12% of the population and, according to Bergman et al., 10-11%. More recent studies show similar data. For their part, Mas et al. (2008) found in a nationwide study that the prevalence of fibromyalgia in Spain was of 4.2% in women and 0.2% in men, mainly in the age range between 40-49 years. All these studies have been performed in countries in the developed world and, most of the time, they have also analysed the prevalence of fibromyalgia (FM) among the same population.
Currently, acupuncture is successfully used in China for the treatment of many chronic diseases. However, in the West, the situation is quite different: acupuncture is little known and not commonly used, giving thus rise to mistrust and misunderstandings. Nevertheless, in recent years, studies have been published both in the East and in the West showing, on the one hand, the intention of traditional Chinese medicine to examine the technique and, on the other, the importance and recognition that the Western medical world is starting to bestow upon Chinese medicine.
METHODS/DESIGN
Objectives
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, Investigator, Outcomes Assessor)
盲法说明
Participants are blinded to the intervention. They will be provided with eye masks so that they cannot see which needles are used in their intervention. Moreover, the same type of equipment will be used with all the participants (although the guide tube to insert the needle is not necessary in true acupuncture).
Given the fact that the person who carries out the intervention is different than the one assessing its effects and the latter does not know which group the evaluated subjects belong to, as well as the fact that the person responsible for the statistics is a third person who ignores which of the two groups has received true acupuncture, this is a triple-blind study.
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
- •• Meeting the criteria set by the American College of Rheumatology for the diagnosis of chronic widespread pain.
- •Accepting to sign the informed consent of participation in the study.
- •Being older than 18 years.
排除标准
- •Suffering from malignant diseases or active rheumatologic disorders (osteoporosis, rheumatoid arthritis, lupus erythematosus, etc.).
- •Suffering from coxarthrosis or severe gonarthrosis.
- •Having previously received acupuncture treatments.
结局指标
主要结局
Pain will be assessed using the Visual Analogue Scale (VAS).
时间窗: up to 8 weeks
The VAS consisted of a 10 mm line with the endpoints 'no pain' and 'worst pain imaginable' .
The Fibromyalgia Impact Questionnaire (FIQ) will be used to analyze the quality of life.
时间窗: up to 8 weeks
次要结局
- The Medical Outcomes Study Sleep Scale (MOS-SS) will be used to assess the sleep quality.(up to 8 weeks)
研究者
Jordi Casado Borrull
Director
Universitat de Girona