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临床试验/NCT03638518
NCT03638518已完成不适用

Effectiveness of Acupuncture vs. Core Stability Based Physiotherapy in Balance and Functional Capacity of Women With Fibromyalgia: A Randomized Controlled Trial

University of Extremadura0 个研究点目标入组 160 人开始时间: 2014年1月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
160
主要终点
Change from physical function item of the Spanish Fibromyalgia Impact Questionnaire at 5 weeks and 13 weeks

研究概览

简要总结

This study analyse the effectiveness of a core stability training Physiotherapy programme versus Acupuncture treatment for the management of balance and functional capacity impairments of women with Fibromyalgia.

详细描述

Objective:

This study investigated the effectiveness of a core stability training Physiotherapy programme versus Acupuncture for the management of balance and functional capacity impairments of women with Fibromyalgia.

Design:

A single-blind randomized clinical controlled trial.

Setting:

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)

盲法说明

Neither the participants nor their therapists were blind to the treatment allocation. However, the assessor was independent to the study and was not aware of the treatments applied or the objective of the therapy.

入排标准

年龄范围
18 Years 至 71 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •women between 18 and 71 years old,
  • •diagnosed with Fibromialgia by a specialized physician,
  • •having subjective sensation of balance impairments.

排除标准

  • •The exclusion criteria were to present any medical contraindication for acupuncture and/or physiotherapy, phobia of needles, adverse reactions to medication that could influence in balance, associated pathologies such as alcoholism or severe visual deficit, to have receive acupuncture or core stability based physiotherapy in the two months previous to the intervention and to do physical exercises that train core stability such as Pilates or Yoga

研究组 & 干预措施

Acupuncture

Experimental

In the acupuncture experimental group, the technique applied included the use of the following acupuncture points of Traditional Chinesse Medicine: GV20, ST36 and BL60 . One needle insertion was performed in each session and in the case of the last two points the needle insertions were done bilaterally.

Patients laid supine on a treatment table with their legs exposed. The skin on the acupuncture points was prepared with 70% ethyl alcohol. One-time-use disposable sterile stainless steel needles (0,26x50mm) were inserted into acupuncture points.

After insertion, acupuncture needles were manually manipulated to obtain the de qi sensation. The needles remained in place for 20 minutes and there were no further manipulations during the retention time.

干预措施: Acupuncture (Other)

Physiotherapy

Experimental

The physiotherapy experimental group received core stability based physiotherapy treatment. Before the beginning of the treatment sessions, the basic principles of core stability exercises were explained to the participants. The exercise programme included 7 exercises. The exercises in the crook lying position were core activation with breathing, single leg lift with knees bent, single leg slides, bridging and knee drop sideways. The exercises completed in side lying included hip external rotation with knees bent and hip abduction with knees straight. After each session gentle stretching of the lower limbs and lumbar spine were performed. The sessions were administered twice a week during 30 minutes with groups of no more than 8 people.

干预措施: Physiotherapy (Other)

control

No Intervention

The control group did not receive any intervention. The participants continued with their routine medical treatment.

结局指标

主要结局

Change from physical function item of the Spanish Fibromyalgia Impact Questionnaire at 5 weeks and 13 weeks

时间窗: Before treatment, after 5 weeks of treatment and after 6 weeks of follow up

The physical function item of the Spanish Fibromyalgia Impact Questionnaire measures functional capacity with a score of 0 to 3.

Change from Berg Balance Scale at 5 weeks and 13 weeks

时间窗: Before treatment, after 5 weeks of treatment and after 6 weeks of follow up

Dynamic balance is the ability to maintain the centre of gravity within the base of support during the performance of functional activities. Berg Balance scale measures dynamic balance through performing multiple tasks and with a score of 0 to 56.

Change from 10 meter walk test at 5 weeks and 13 weeks

时间窗: Before treatment, after 5 weeks of treatment and after 6 weeks of follow up

10 meter walk test measures walking speed and performance which is related to dynamic balance. The unit use is meter/second.

Change from the monopodal stance test at 5 weeks and 13 weeks

时间窗: Before treatment, after 5 weeks of treatment and after 6 weeks of follow up

Static balance and postural control is the ability to maintain the centre of gravity within the base of support. Monopodal stance test measures static balance in percentage through posturography study.

Change from the centre of gravity at 5 weeks and 13 weeks

时间窗: Before treatment, after 5 weeks of treatment and after 6 weeks of follow up

Static balance and postural control is the ability to maintain the centre of gravity within the base of support. Centre of gravity is measured in percentage through posturography study

Change from Time Up and Go test at 5 weeks and 13 weeks

时间窗: Before treatment, after 5 weeks of treatment and after 6 weeks of follow up

Time up and Go test measures dynamic balance showed in seconds

Change from Health Assessement Questionnaire at 5 weeks and 13 weeks

时间窗: Before treatment, after 5 weeks of treatment and after 6 weeks of follow up

Health Assessement questionnaire measures the functional capacity of a subject. It provides an impairment score of 0 to 3.

次要结局

  • Change from joint stiffness levels measured with the visual analogue scale at 5 weeks and 13 weeks(Before treatment, after 5 weeks of treatment and after 6 weeks of follow up)
  • Change from perceived difficulty to work measured with the visual analogue scale at 5 weeks and 13 weeks(Before treatment, after 5 weeks of treatment and after 6 weeks of follow up)
  • Change from the Spanish Fibromyalgia Impact Questionnaire at 5 weeks and 13 weeks(Before treatment, after 5 weeks of treatment and after 6 weeks of follow up)
  • Change from pain intensity levels measured with the visual analogue scale at 5 weeks and 13 weeks(Before treatment, after 5 weeks of treatment and after 6 weeks of follow up)
  • Change from depression level measured with the visual analogue scale at 5 weeks and 13 weeks(Before treatment, after 5 weeks of treatment and after 6 weeks of follow up)

研究者

发起方
University of Extremadura
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elisa María Garrido Ardila

Profesor of Physiotherapy

University of Extremadura

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