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Investigation of Acute Effect of ESWT and ESWT+KT on Pain and Grip Strength

Primary Purpose

Pain, Muscle Strength, Lateral Epicondylitis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ESWT
Kinesiotaping Application
Sponsored by
Ankara Yildirim Beyazıt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Tennis Elbow, Taping, Grip Strength, Pain

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of Lateral Epicondylitis Disease
  • has been doing professional sports for at least three years

Exclusion Criteria:

  • Having systemic problems,
  • Having health problems,
  • Has undergone any surgical operation in the upper extremity
  • Has suffered upper extremity injury in the last three months
  • Lack of inclusion criteria
  • Neurological and orthopedic problems of the upper extremity.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    ESWT

    ESWT+KT

    Arm Description

    the first group:The group that will receive Extra corporeal shock wave therapy

    the second group:The group that will receive Extra corporeal shock wave therapy + Kinesiotaping application

    Outcomes

    Primary Outcome Measures

    Pain Level: visual analog scale
    The pain level will evaluate By visual analog scale;min:0=no pain, maximum 10=irresistible pain
    Muscle Strength
    The muscle strength will evaluate by hand grip strength by dynamometer, is evaluating by mmHg bigger means stronger

    Secondary Outcome Measures

    Disability Level/Functionality
    By the DASH (Disability arm shoulder hand) questionaire, min =0, maks 100 the bigger point means worse functionality

    Full Information

    First Posted
    November 29, 2018
    Last Updated
    December 3, 2018
    Sponsor
    Ankara Yildirim Beyazıt University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03763513
    Brief Title
    Investigation of Acute Effect of ESWT and ESWT+KT on Pain and Grip Strength
    Official Title
    Investigation of Acute Effect of Extracorporeal Shock Wave Therapy and Extracorporeal Shock Wave Therapy+Kinesyotaping on Pain and Grip Strength in Patients/Athletes With Lateral Epicondylitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2019 (Anticipated)
    Primary Completion Date
    June 1, 2019 (Anticipated)
    Study Completion Date
    July 1, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ankara Yildirim Beyazıt University

    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
    The aim of this study was to investigate the acute effect of CT application in combination with ESWT and ESWT on pain and grip strength in athletes/patients with lateral epicondylitis.It is planned that at least 30 athletes aged 18-40 who are at the Ministry of Youth and Sports, Ministry of Health, Ministry of Health Affairs and who have been diagnosed with LE by specialist doctor. After taking the information about birth dates, height, weight and dominant sides of the athletes who are willing to participate in the study, pain intensities and hand grip strengths will be evaluated. Then the athletes will be randomly divided into 2 groups according to closed envelope method. First group ESWT application; 4 sessions will be held for 4 weeks. The second group included ESWT + CT; 4 sessions will be held for 4 weeks. Pain severity and hand grip strength will be evaluated again after treatment.
    Detailed Description
    Lateral epicondylitis (LE); the most common cause of elbow pain. It is typically characterized by pain around the lateral epicondyle during resistant wrist extension. This condition has been reported to occur as a result of degenerative angiofibroblastic hyperplasia of the wrist extensor tendons due to repetitive microtrauma. Although conservative treatments are usually used in lateral epicondylitis, many of them do not have sufficient evidence. In some cases, the healing phase lasts for months, which may be long enough to affect quality of life and sport performance. Extracorporeal shock wave therapy (ESWT) is used in musculoskeletal problems with a possible mechanism of action, including hyperstimulation analgesia, neovascularization, and induction of the healing process. However, this method is a painful method due to the shock wave applied and may cause temporary redness in the area of application. This may cause the subcutaneous fascia of the affected area to be affected by the application pressure. Kinesiotaping (KT) is widely used in the treatment of various musculoskeletal problems. The band, invented by the Japanese chiropractor Kenzo Kase in the 1970s, is a heat-sensitive acrylic adhesive and an elastic woven cotton stripe with a maximum tensile strength of up to about 40-60% of its total length. Many effects of KT have been hypothesised, including improvement of feedback and correction of the articular alignment disorder. KT has an effect on the skin and fascia. recovery will be provided faster. The aim of this study is to compare the effects of ESWT application with ESWT + KT application. In this study, our hypothesis is that ESWT + KT application will have more effect on pain and muscle strength in LE patients than ESWT alone.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Muscle Strength, Lateral Epicondylitis, Kinesio Taping
    Keywords
    Tennis Elbow, Taping, Grip Strength, Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ESWT
    Arm Type
    Active Comparator
    Arm Description
    the first group:The group that will receive Extra corporeal shock wave therapy
    Arm Title
    ESWT+KT
    Arm Type
    Experimental
    Arm Description
    the second group:The group that will receive Extra corporeal shock wave therapy + Kinesiotaping application
    Intervention Type
    Device
    Intervention Name(s)
    ESWT
    Intervention Description
    Extracorporeal Shock Wave Therapy=ESWT
    Intervention Type
    Other
    Intervention Name(s)
    Kinesiotaping Application
    Intervention Description
    Kinesiotaping=KT (CT)
    Primary Outcome Measure Information:
    Title
    Pain Level: visual analog scale
    Description
    The pain level will evaluate By visual analog scale;min:0=no pain, maximum 10=irresistible pain
    Time Frame
    4 weeks
    Title
    Muscle Strength
    Description
    The muscle strength will evaluate by hand grip strength by dynamometer, is evaluating by mmHg bigger means stronger
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Disability Level/Functionality
    Description
    By the DASH (Disability arm shoulder hand) questionaire, min =0, maks 100 the bigger point means worse functionality
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinical diagnosis of Lateral Epicondylitis Disease has been doing professional sports for at least three years Exclusion Criteria: Having systemic problems, Having health problems, Has undergone any surgical operation in the upper extremity Has suffered upper extremity injury in the last three months Lack of inclusion criteria Neurological and orthopedic problems of the upper extremity.

    12. IPD Sharing Statement

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    Investigation of Acute Effect of ESWT and ESWT+KT on Pain and Grip Strength

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