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Eccentric Exercise in Epicondylitis

Primary Purpose

Tendinopathy

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Exercise
Sponsored by
Andaluz Health Service
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tendinopathy focused on measuring Epicondylitis, Tennis elbow, Eccentric exercise

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Antonio Oya CaseroRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Eccentric exercise by physiotherapist

Illustrated booklet

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Visual analogue scale of pain
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.
Visual analogue scale of pain
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.
Quick-Dash
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.
Quick-Dash
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.
Satisfaction questionnaire
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: Very satisfied Satisfied Neither satisfied nor unsatisfied Unsatisfied Very unsatisfied
Satisfaction questionnaire
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: Very satisfied Satisfied Neither satisfied nor unsatisfied Unsatisfied Very unsatisfied

Secondary Outcome Measures

Full Information

First Posted
June 22, 2019
Last Updated
June 25, 2019
Sponsor
Andaluz Health Service
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1. Study Identification

Unique Protocol Identification Number
NCT03996928
Brief Title
Eccentric Exercise in Epicondylitis
Official Title
Eccentric Exercise in Epicondylitis: Direct Application By Physical Therapist Vs Self-Application By Patient
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
November 1, 2019 (Anticipated)
Study Completion Date
December 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Andaluz Health Service

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendinopathy
Keywords
Epicondylitis, Tennis elbow, Eccentric exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single blind randomized controlled trial INDEPENDENT VARIABLES Age, Sex, Work activity (referred to a superior member): intense -including, among other kind of activities, keyboards users and housewives-light. Basal pain according to visual analogue scale (VAS) of 100 mm. Baseline disability according to the DASH questionnaire (Disabilities of the Arm, Shoulder and Hand), which is self-administered. DEPENDENT VARIABLES Pain according to the aforementioned scale just after treatment (2 weeks) and at 3 months. Disability according to the aforementioned questionnaire just after the treatment (2 weeks) and at three months. Satisfaction with the treatment right after it (2 weeks) and at three months. A Likert scale of five points ( very satisfied, satisfied, neither satisfied nor unsatisfied, very unsatisfied) will be used. Co-interventions (Systemic and/or topical route drugs, physiotherapy modalities received outside the system, use of orthoses).
Masking
Investigator
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Eccentric exercise by physiotherapist
Arm Type
Experimental
Arm Description
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.
Arm Title
Illustrated booklet
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise
Primary Outcome Measure Information:
Title
Visual analogue scale of pain
Description
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.
Time Frame
At two weeks
Title
Visual analogue scale of pain
Description
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.
Time Frame
Three months
Title
Quick-Dash
Description
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.
Time Frame
At two weeks
Title
Quick-Dash
Description
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.
Time Frame
Three months
Title
Satisfaction questionnaire
Description
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: Very satisfied Satisfied Neither satisfied nor unsatisfied Unsatisfied Very unsatisfied
Time Frame
At two weeks
Title
Satisfaction questionnaire
Description
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: Very satisfied Satisfied Neither satisfied nor unsatisfied Unsatisfied Very unsatisfied
Time Frame
Three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ANTONIO OYA
Phone
+34953266123
Email
fisyrec@fisyrec.com
First Name & Middle Initial & Last Name or Official Title & Degree
JUAN ALFONSO ANDRADE
Phone
34 953 00 80 40
Email
juanalfonsoandrade@gmail.com
Facility Information:
Facility Name
Antonio Oya Casero
City
Jaén
ZIP/Postal Code
23003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JUAN ALFONSO ANDRADE
Phone
+34 953 00 80 40
Email
juanalfonsoandrade@gmail.com
First Name & Middle Initial & Last Name & Degree
MANOLO MADERA
First Name & Middle Initial & Last Name & Degree
ROSARIO GARCÍA
First Name & Middle Initial & Last Name & Degree
ENCARNACION CERÓN

12. IPD Sharing Statement

Plan to Share IPD
No
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Eccentric Exercise in Epicondylitis

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