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Clinical Trials/NCT03996928
NCT03996928
Unknown
Not Applicable

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

Andaluz Health Service1 site in 1 country20 target enrollmentJanuary 1, 2017
ConditionsTendinopathy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tendinopathy
Sponsor
Andaluz Health Service
Enrollment
20
Locations
1
Primary Endpoint
Satisfaction questionnaire
Last Updated
6 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
January 1, 2017
End Date
December 1, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Andaluz Health Service
Responsible Party
Principal Investigator
Principal Investigator

ANTONIO OYA CASERO

Principal Investigator

Andaluz Health Service

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.

Outcomes

Primary Outcomes

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

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.

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.

Study Sites (1)

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