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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03763513
Other study ID # AYBU
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date July 1, 2019

Study information

Verified date December 2018
Source Ankara Yildirim Beyazit University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date July 1, 2019
Est. primary completion date June 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 40 Years
Eligibility 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.

Study Design


Intervention

Device:
ESWT
Extracorporeal Shock Wave Therapy=ESWT
Other:
Kinesiotaping Application
Kinesiotaping=KT (CT)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ankara Yildirim Beyazit University

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Level: visual analog scale The pain level will evaluate By visual analog scale;min:0=no pain, maximum 10=irresistible pain 4 weeks
Primary Muscle Strength The muscle strength will evaluate by hand grip strength by dynamometer, is evaluating by mmHg bigger means stronger 4 weeks
Secondary Disability Level/Functionality By the DASH (Disability arm shoulder hand) questionaire, min =0, maks 100 the bigger point means worse functionality 4 weeks
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