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临床试验/NCT03996928
NCT03996928Unknown不适用

Eccentric Exercise in Epicondylitis: Direct Application By Physical Therapist Vs Self-Application By Patient

Andaluz Health Service2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
2
主要终点
Satisfaction questionnaire

研究概览

简要总结

There is more and more evidence of the importance of the role of kinesitherapy in the management of epicondylitis, specifically (but not exclusively) of eccentric exercise. Since eccentric kinesitherapy, when applied in a systematic way by a physiotherapist, consumes time and human resources in a significant way, and in the case of such a prevalent pathology, it is frequent that strategies of training the patient are addressed so that this is who perform the exercises after learning them. However, it is not proven that the efficacy and safety of this approach is equivalent to treatment applied by a physiotherapist.

A randomized single-blind controlled trial is conducted that compares both treatment approaches for epicondylitis (eccentric exercises applied directly by a physiotherapist for 10 sessions, and eccentric exercises applied by the patient during the same time) in terms of efficacy against pain, functionality and patient satisfaction, all this within the framework of the public health system.

详细描述

The main objective of this study is:

To compare the efficacy of an eccentric exercise program applied to patients with epicondylosis by a structured manual program in ten sessions and by an illustrated booklet.

The specific objectives of this study are:

Compare the effectiveness of the above-cited approaches in terms of pain Compare the effectiveness of the above-cited approaches in terms of function Compare the effectiveness of the above-cited approaches in terms of satisfaction

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 (Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 65 years old
  • Epicondylosis of three or more months of evolution.
  • Acceptance of the voluntary participation in the study and signature of the informed consent.

排除标准

  • Generalized musculoskeletal pain.
  • Rheumatological affections involving of the upper limb.
  • Cervicobrachialgia.
  • Previous trauma in upper limb.
  • Neurological or other pathology that may interfere with the function of the upper limb.
  • Being out of work or in litigation due to the pathology of the upper limb.

研究组 & 干预措施

Eccentric exercise by physiotherapist

Experimental

A physiotherapist will apply (in this order) a plan of stretching exercises, warm-up exercises and eccentric exercises of epicondylar muscle,according to a program of 10 sessions of 20 minutes each, during two weeks.

Before exercise, ultrasounds will be applied at intensity of 0.1 wat/cm2, which is considered as a placebo, in order to achieve greater adherence and monitor the treatment.

干预措施: Exercise (Other)

Illustrated booklet

Active Comparator

A physiotherapist will train the patient an exercise plan equivalent to the one above explained with the help of illustrations. Now, in order to achieve palmar flexion at the same time the patients will contract their epicondylar muscles (the eccentric effect), and elastic band is used.

干预措施: Exercise (Other)

结局指标

主要结局

Satisfaction questionnaire

时间窗: Three months

A survey will be carried out to find out what the patient has perceived by asking a question about his satisfaction with the treatment received, choosing one of the following answers: 1. Very satisfied 2. Satisfied 3. Neither satisfied nor unsatisfied 4. Unsatisfied 5. Very unsatisfied

Quick-Dash

时间窗: Three months

At least 10 of the 11 questions must be completed to calculate the score Disability / Symptom of Quick DASH. The assigned values for all the complete answers are summed and averaged, giving as a result, a score based on five. This value is then taken to a score based on 100 subtracting 1 and multiplying it by 25. A higher score greater disability.

Visual analogue scale of pain

时间窗: Three months

The Visual Analogue Scale (VAS) quantifies of pain described by the patient with maximum reproducibility among observers. It consists of a 10-centimeter horizontal line, at the ends of which the extreme expressions of a symptom are marked: no pain on the left wiht a score 0, and the highest possible pain on the right wiht a score 10. The patient is asked to mark the point that indicates the intensity in the line and is measured with a millimeter ruler. The intensity is expressed in centimeters or millimeters. A value lower than 4 in the VAS means mild or mild-moderate pain, a value between 4 and 6 implies the presence of moderate-severe pain, and a value greater than 6 implies the presence of very intense pain.

次要结局

未报告次要终点

研究者

发起方
Andaluz Health Service
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

ANTONIO OYA CASERO

Principal Investigator

Andaluz Health Service

研究点 (2)

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