- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03763513
Investigation of Acute Effect of ESWT and ESWT+KT on Pain and Grip Strength
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
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.
Study Overview
Status
Conditions
Intervention / 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: ESWT
the first group:The group that will receive Extra corporeal shock wave therapy
|
Extracorporeal Shock Wave Therapy=ESWT
|
|
Experimental: ESWT+KT
the second group:The group that will receive Extra corporeal shock wave therapy + Kinesiotaping application
|
Extracorporeal Shock Wave Therapy=ESWT
Kinesiotaping=KT (CT)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
4 weeks
|
|
Muscle Strength
Time Frame: 4 weeks
|
The muscle strength will evaluate by hand grip strength by dynamometer, is evaluating by mmHg bigger means stronger
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
4 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AYBU
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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