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
About this trial
This is an interventional treatment trial for Pain focused on measuring Tennis Elbow, Taping, Grip Strength, Pain
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.
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
NCT ID
NCT03763513
First Posted
November 29, 2018
Last Updated
December 3, 2018
Sponsor
Ankara Yildirim Beyazıt University
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
Learn more about this trial
Investigation of Acute Effect of ESWT and ESWT+KT on Pain and Grip Strength
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