Effect of the Kinesio Taping in Patients With Fibromyalgia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Pain intensity
研究概览
简要总结
The prevalence of the fibromyalgia is about 10-15% in the European countries. It is unclear the etiology and pathogenesis of the syndrome. Several factors such as dysfunction of the central and autonomic nervous systems, neurotransmitters, hormones, immune system, external stressors, psychiatric aspects, and others seem to be involved. But the symptom commonly expressed by the people who suffer from it is pain.
The main goal of the present study is to analyse the effect of the kinesiotaping on the pain, comfort and postural position of the patient with fibromyalgia.
详细描述
All of the participants were recruited, in a non-probabilistic way, from the Valencian Association of Affected of Fibromyalgia from date to april 2016. Inclusion criteria include: age between 18 and 70 years old and diagnosis of fibromyalgia based on the American College of Rheumatology (ACR) diagnostic criteria. Once they expressed their interest in taking part of the study, potential participants underwent an examination by a rheumatologist of the association to confirm the diagnosis of fibromyalgia. People with other different diagnosis, musculoskeletal or neurological disorders that prevented the follow-up study, infections, whiplash, migraine, skin hypersensitivity or heart devices were excluded.
The participants were randomly allocated (random numbers table) to two different groups depending on the placement of the Kinesio Tape © (KT) by a physiotherapist which did not participated in the study. Thus, one group was composed by 18 women and was called "Upper trunk group" (UTG). The other group, composed by 17 women and called "Global trunk group" (GTG).
Patients were informed about the purpose of the study, procedures and risks, and they provided written informed consent before the treatment. The study protocol was approved by the authors´ University Ethic Committee where the study was conducted. All procedures were conducted in accordance to the Declaration of Helsinki.
A prospective, randomized, double blind, controlled trial was carried out. Participants were assessed two times, one before the intervention and another afterwards. They received a treatment of kinesiotaping during three weeks. Participants came to our laboratory each week in order to change their bandage and assure the adherence to the treatment.
The physiotherapist who conducted the assessments was blinded to the treatment received by the patients and the statistician was completely blinded to the goals of the study. The physiotherapist who applied the treatment had an extensive experience Kinesio Tape ©.
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)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 70 years old and diagnosis of fibromyalgia based on the American College of Rheumatology (ACR) diagnostic criteria (Wolfe et al., 2011). Once they expressed their interest in taking part of the study, potential participants underwent an examination by a rheumatologist of the association to confirm the diagnosis of fibromyalgia.
排除标准
- •People with other different diagnosis, musculoskeletal or neurological disorders that prevented the follow-up study, infections, whiplash, migraine, skin hypersensitivity or heart devices were excluded.
结局指标
主要结局
Pain intensity
时间窗: three weeks
The pain intensity was recorded by a visual analogue scale (VAS) of pain. The pain was expressed on a scale of 0-10, with 0 being "no pain" and 10 "maximum tolerable pain."
次要结局
- Impact on quality of life.(three weeks)
- Physical well-being(three weeks)
- Perception of change(three weeks)
- Comfort.(three weeks)
- Trunk posture.(three weeks)
研究者
GEMMA V ESPÍ LÓPEZ, PhD
Dr
University of Valencia