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Eccentric Exercise in Epicondylitis

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ClinicalTrials.gov Identifier: NCT03996928
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
ANTONIO OYA CASERO, Andaluz Health Service

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.


Condition or disease Intervention/treatment Phase
Tendinopathy Other: Exercise Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (Investigator)
Primary Purpose: Treatment
Official Title: Eccentric Exercise in Epicondylitis: Direct Application By Physical Therapist Vs Self-Application By Patient
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


  4. 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.


  5. 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

  6. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03996928


Contacts
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Contact: ANTONIO OYA +34953266123 fisyrec@fisyrec.com
Contact: JUAN ALFONSO ANDRADE 34 953 00 80 40 juanalfonsoandrade@gmail.com

Locations
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Spain
Antonio Oya Casero Recruiting
Jaén, Spain, 23003
Contact: JUAN ALFONSO ANDRADE    +34 953 00 80 40    juanalfonsoandrade@gmail.com   
Sub-Investigator: MANOLO MADERA         
Sub-Investigator: ROSARIO GARCÍA         
Sub-Investigator: ENCARNACION CERÓN         
Sponsors and Collaborators
Andaluz Health Service
Publications:

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Responsible Party: ANTONIO OYA CASERO, Principal Investigator, Andaluz Health Service
ClinicalTrials.gov Identifier: NCT03996928    
Other Study ID Numbers: OYA-EXC-2019-1
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by ANTONIO OYA CASERO, Andaluz Health Service:
Epicondylitis
Tennis elbow
Eccentric exercise
Additional relevant MeSH terms:
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Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries