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Efficacy of a Stretching Protocol for Lateral Epicondylitis

Primary Purpose

Epicondylitis, Lateral, Elbow Tendinopathy, Epicondylitis of the Elbow

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Passive and active analytical stretching exercises
Static stretching of the extensor carpi radialis brevis and eccentric strengthening of the wrist extensor musculature
Sponsored by
University of Cadiz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epicondylitis, Lateral focused on measuring epicondylitis, Elbow Tendinopathy, stretch, physiotherapy

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult subjects over 18 years of age.
  • Clinical diagnosis of lateral epicondylitis made by the Rehabilitation Physicians collaborating in this study.
  • Patient's prior informed consent for inclusion in the study.

Exclusion Criteria:

  • Patients with significant psychological, neurological and physical impairments that would prevent the recruitment of the information necessary for the research.
  • Patients with significant psychological, neurological and physical alterations that would prevent the application of the treatments necessary for the research.
  • Patients in a situation of legal litigation that could be affected by their participation in this study.
  • Refusal to participate in the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Experimental

    Arm Label

    Control group

    Experimental

    Arm Description

    Static stretching of the extensor carpi radialis brevis and eccentric strengthening of the wrist extensor musculature

    Passive and active analytical stretching exercises described by Neiger and Simons , applying them to the muscle chain involved in lateral epicondylitis described by Busquet

    Outcomes

    Primary Outcome Measures

    Elbow Pain
    Measurement of pain perception: by means of a visual analogue scale (VAS), consisting of drawing a 100 mm long line in a centred position on a DINA A4 paper, cut with a segment perpendicular to it at each end. After informing the subject that the left and right segments represent the absence of pain and the maximum pain imaginable respectively, the subject is asked to point with a pencil on the line to the point where their pain is located.
    Grip strength
    A dynamometer shall be used for the test. Special care was taken to ensure that all subjects had the same position in order to be able to compare results. After informing the patient how to perform this test, the evaluation process consists of performing a maximum grip force for three seconds, executing it three times and with a minimum time interval of 60 seconds between them to avoid muscle fatigue. After completion of the test, the arithmetic mean of the results will be considered as the result.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 3, 2022
    Last Updated
    February 18, 2022
    Sponsor
    University of Cadiz
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05238090
    Brief Title
    Efficacy of a Stretching Protocol for Lateral Epicondylitis
    Official Title
    Efficacy of a Whole Upper Limb Stretching Protocol for Lateral Epicondylitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 30, 2022 (Anticipated)
    Primary Completion Date
    May 3, 2022 (Anticipated)
    Study Completion Date
    May 5, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Cadiz

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Evaluation of the applying a stretching protocol to lateral epicondylitis.
    Detailed Description
    Epicondylitis is one of the most common soft tissue disorders of the locomotor system of the upper limb. Despite the existence of a large number of therapeutic alternatives for this type of injury, no agreed treatment protocol has been found. Some authors even suggest treating the patient from a more global biomechanical perspective. OBJECTIVES. To evaluate the efficacy of applying a stretching protocol to the entire muscle chain involved in this injury and circumscribed to the entire affected upper limb. METHODOLOGY. The study will be made up of 40 patients of both genders, randomly distributed in two groups: a control group made up of twenty patients to whom the usual Physiotherapy treatment will be applied, and an experimental group made up of the rest of the subjects, in which a stretching protocol will be applied to the whole upper limb affected and defined for this study. The evaluation process will consist of measuring pain perception using a visual analogue scale (VAS) and grip strength with a dynamometer. These measurements will be performed on all study subjects before starting treatment, at week 4 and week 6.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Epicondylitis, Lateral, Elbow Tendinopathy, Epicondylitis of the Elbow, Epicondylitis
    Keywords
    epicondylitis, Elbow Tendinopathy, stretch, physiotherapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Prospective, randomised, single-blind, multicentre, randomised study.
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    Other
    Arm Description
    Static stretching of the extensor carpi radialis brevis and eccentric strengthening of the wrist extensor musculature
    Arm Title
    Experimental
    Arm Type
    Experimental
    Arm Description
    Passive and active analytical stretching exercises described by Neiger and Simons , applying them to the muscle chain involved in lateral epicondylitis described by Busquet
    Intervention Type
    Other
    Intervention Name(s)
    Passive and active analytical stretching exercises
    Intervention Description
    For each stretching technique described, 3 repetitions of 15 seconds duration will be performed of 15 seconds duration each, within the patient's tolerance threshold. In any case, the impossibility of performing any technique due to exacerbation of pain shall be recorded in a patient record created for this study, noting the technique in question and the reason for its technique in question and the reason for its non-application. Passive stretches shall be applied in the same order for all subjects. The physiotherapists in charge of applying the treatments will be trained in advance in the different techniques to be applied and will not in the different techniques to be applied and shall not intervene at any time in the two previous phases. Both the control group and the study group will receive their respective treatments two days a week for four weeks. In no case will any other type of treatment be associated treatment during the whole process.
    Intervention Type
    Other
    Intervention Name(s)
    Static stretching of the extensor carpi radialis brevis and eccentric strengthening of the wrist extensor musculature
    Intervention Description
    Static stretching of the extensor carpi radialis brevis and eccentric strengthening of the wrist extensor musculature
    Primary Outcome Measure Information:
    Title
    Elbow Pain
    Description
    Measurement of pain perception: by means of a visual analogue scale (VAS), consisting of drawing a 100 mm long line in a centred position on a DINA A4 paper, cut with a segment perpendicular to it at each end. After informing the subject that the left and right segments represent the absence of pain and the maximum pain imaginable respectively, the subject is asked to point with a pencil on the line to the point where their pain is located.
    Time Frame
    1,5 months
    Title
    Grip strength
    Description
    A dynamometer shall be used for the test. Special care was taken to ensure that all subjects had the same position in order to be able to compare results. After informing the patient how to perform this test, the evaluation process consists of performing a maximum grip force for three seconds, executing it three times and with a minimum time interval of 60 seconds between them to avoid muscle fatigue. After completion of the test, the arithmetic mean of the results will be considered as the result.
    Time Frame
    1,5 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult subjects over 18 years of age. Clinical diagnosis of lateral epicondylitis made by the Rehabilitation Physicians collaborating in this study. Patient's prior informed consent for inclusion in the study. Exclusion Criteria: Patients with significant psychological, neurological and physical impairments that would prevent the recruitment of the information necessary for the research. Patients with significant psychological, neurological and physical alterations that would prevent the application of the treatments necessary for the research. Patients in a situation of legal litigation that could be affected by their participation in this study. Refusal to participate in the study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Maria Jesus Vinolo
    Phone
    697953671
    Email
    mariajesus.vinolo@uca.es
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Francisco Javier Martin
    Organizational Affiliation
    Cadiz University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Publication in journals indexed in the Journal Citation Report (JCR),in the field of Rehabilitation and Physical Medicine and Physiotherapy. 2. Dissemination of results in national and international Congresses of Rehabilitation and Physical Medicine and Physiotherapy. 3. Dissemination to the public, press releases and explanatory brochures of the project.
    IPD Sharing Time Frame
    In two years. In December 2023.
    IPD Sharing Access Criteria
    open file
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    Efficacy of a Stretching Protocol for Lateral Epicondylitis

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