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

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ClinicalTrials.gov Identifier: NCT03763513
Recruitment Status : Unknown
Verified December 2018 by Bihter Aslanyurek, Ankara Yildirim Beyazıt University.
Recruitment status was:  Not yet recruiting
First Posted : December 4, 2018
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Bihter Aslanyurek, Ankara Yildirim Beyazıt University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Pain Muscle Strength Lateral Epicondylitis Kinesio Taping Device: ESWT Other: Kinesiotaping Application Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: ESWT
the first group:The group that will receive Extra corporeal shock wave therapy
 Device: ESWT
Extracorporeal Shock Wave Therapy=ESWT
Experimental: ESWT+KT
the second group:The group that will receive Extra corporeal shock wave therapy + Kinesiotaping application
 Device: ESWT
Extracorporeal Shock Wave Therapy=ESWT

Other: Kinesiotaping Application
Kinesiotaping=KT (CT)


Outcome Measures
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Primary Outcome Measures :
  1. Pain Level: visual analog scale [ Time Frame: 4 weeks ]
    The pain level will evaluate By visual analog scale;min:0=no pain, maximum 10=irresistible pain

  2. Muscle Strength [ Time Frame: 4 weeks ]
    The muscle strength will evaluate by hand grip strength by dynamometer, is evaluating by mmHg bigger means stronger


Secondary Outcome Measures :
  1. Disability Level/Functionality [ Time Frame: 4 weeks ]
    By the DASH (Disability arm shoulder hand) questionaire, min =0, maks 100 the bigger point means worse functionality


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Bihter Aslanyurek, Reserach Assistant. PhD. PT. Bihter Akınoğlu, Ankara Yildirim Beyazıt University
ClinicalTrials.gov Identifier: NCT03763513    
Other Study ID Numbers: AYBU
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bihter Aslanyurek, Ankara Yildirim Beyazıt University:
Tennis Elbow
Taping
Grip Strength
Pain
Additional relevant MeSH terms:
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Tennis Elbow
Elbow Tendinopathy
Tendinopathy
Muscular Diseases
 Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries