Eccentric Exercise in Epicondylitis

June 25, 2019 updated by: ANTONIO OYA CASERO, Andaluz Health Service

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Jaén, Spain, 23003
        • Recruiting
        • Antonio Oya Casero
        • Contact:
        • Sub-Investigator:
          • MANOLO MADERA
        • Sub-Investigator:
          • ROSARIO GARCÍA
        • Sub-Investigator:
          • ENCARNACION CERÓN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Eccentric exercise by physiotherapist

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.
Other: Exercise
Active Comparator: Illustrated booklet
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.
Other: Exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue scale of pain
Time Frame: At two weeks

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.
At two weeks
Visual analogue scale of pain
Time Frame: 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.
Three months
Quick-Dash
Time Frame: At two weeks

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.
At two weeks
Quick-Dash
Time Frame: 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.
Three months
Satisfaction questionnaire
Time Frame: At two weeks

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
At two weeks
Satisfaction questionnaire
Time Frame: 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
Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andaluz Health Service

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Anticipated)

November 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

June 22, 2019

First Submitted That Met QC Criteria

June 22, 2019

First Posted (Actual)

June 25, 2019

Study Record Updates

Last Update Posted (Actual)

June 27, 2019

Last Update Submitted That Met QC Criteria

June 25, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OYA-EXC-2019-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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