Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2026-02-25 @ 4:12 AM
Study NCT ID:
NCT02596659
Status:
COMPLETED
Last Update Posted:
2015-11-04
First Post:
2015-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Radial Extracorporeal Shockwave Therapy on Tennis Elbow
Sponsor:
Chang Gung Memorial Hospital
Organization:
Study Overview
Official Title:
Effectiveness of Radial Extracorporeal Shockwave Therapy on Tennis Elbow
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background:
Tennis elbow, also known as lateral epicondylitis, is the inflammatory status of insertion site of common extensor tendon to humerus. It is usually related to overuse of local muscle. Radial extracorporeal shock wave therapy (rESWT) is a non-invasive physical treatment. It applies shockwave energy to the lesion site, enhancing the growth of microvascularity, inducing tissue repair, and thus relieving the symptom.
The purpose of this study is to understand the therapeutic effect of rESWT to tennis elbow.
Material and Methods
* Subjects: 30 patients will be recruited from outpatient department of physical medicine and rehabilitation department.
* Duration: 2013.09.01-2015.05.31
* Methods: The patients will be randomly divided into the experimental group and the control group through the draw, with 15 patients in each group. Patients in the experimental group receive rESWT plus routine rehabilitation program. Patients in the control group receive sham shockwave therapy plus routine rehabilitation program.
* Assessment: Before the therapy starts, patients who match the inclusion criteria will be evaluated using tools mentioned below:
* General data: age, sex, body height, body weight, affected side, medical history
* Assess upper extremity function and symptom with Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)
* Assess severity of pain with Visual Analogue Scale (VAS)
* Assess grip strength with grip strength dynamometer
* Measure the size of tear (if any) of common extensor tendon through ultrasonography, and assess the texture of common extensor tendon through real-time sonoelastography (RTS)
Patients will be followed up 6 weeks, 3months, and 6 months after therapy starts. They will be re-assessed of upper extremity function and symptom, severity of pain, grip strength, and presentation on ultrasonography and RTS.
Tennis elbow, also known as lateral epicondylitis, is the inflammatory status of insertion site of common extensor tendon to humerus. It is usually related to overuse of local muscle. Radial extracorporeal shock wave therapy (rESWT) is a non-invasive physical treatment. It applies shockwave energy to the lesion site, enhancing the growth of microvascularity, inducing tissue repair, and thus relieving the symptom.
The purpose of this study is to understand the therapeutic effect of rESWT to tennis elbow.
Material and Methods
* Subjects: 30 patients will be recruited from outpatient department of physical medicine and rehabilitation department.
* Duration: 2013.09.01-2015.05.31
* Methods: The patients will be randomly divided into the experimental group and the control group through the draw, with 15 patients in each group. Patients in the experimental group receive rESWT plus routine rehabilitation program. Patients in the control group receive sham shockwave therapy plus routine rehabilitation program.
* Assessment: Before the therapy starts, patients who match the inclusion criteria will be evaluated using tools mentioned below:
* General data: age, sex, body height, body weight, affected side, medical history
* Assess upper extremity function and symptom with Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)
* Assess severity of pain with Visual Analogue Scale (VAS)
* Assess grip strength with grip strength dynamometer
* Measure the size of tear (if any) of common extensor tendon through ultrasonography, and assess the texture of common extensor tendon through real-time sonoelastography (RTS)
Patients will be followed up 6 weeks, 3months, and 6 months after therapy starts. They will be re-assessed of upper extremity function and symptom, severity of pain, grip strength, and presentation on ultrasonography and RTS.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: