Effectiveness of Radial Extracorporeal Shockwave Therapy on Tennis Elbow

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02596659
Study type	Interventional
Source	Chang Gung Memorial Hospital
Contact
Status	Completed
Phase	N/A
Start date	September 2013
Completion date	May 2015

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.