NCT02596659

Effectiveness of Radial Extracorporeal Shockwave Therapy on Tennis Elbow

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lateral Epicondylosis
• Lateral Epicondylitis
• Tennis Elbow

Interventions

Type	Name	Description
PROCEDURE	Radial extracorporeal shock wave therapy (rESWT)	Each participant in the experimental group received rESWT for 3 sessions, consisting of 2000 impulses for each session, and one session per week over 3 weeks (a total of 6000 shock waves were given). The pneumatic pressure was set at the maximum level tolerable for each patient. The frequency of pulses was set at 10 Hz.
PROCEDURE	sham shockwave therapy	Sham shockwave therapy were given by the same physiatrist using the same machine as the experimental group, with the same rESWT protocol (3 sessions, 2000 impulses for each session, one session per week over 3 weeks) and the same frequency (10 Hz) of impulses, but the pneumatic pressure was set at 0.1 bar, with a similar sound to the regular rESWT but without actual energy conduction.
PROCEDURE	Physical therapy	The physical therapy program was performed 3 times a week over the same 3 weeks as rESWT, and consisted of 5 minutes of ultrasound diathermy, 15 minutes of transcutaneous electrical nerve stimulation (TENS), and 10 minutes of therapeutic exercise, including wrist common extensor stretching and self-massage.

Timeline

• Start date: 2013-09-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2015-11-04
• Last updated: 2015-11-04

Locations

1 site across 1 country: Taiwan