An interventional study of Radial extracorporeal shock wave therapy (rESWT) and sham shockwave therapy in Lateral Epicondylosis, Lateral Epicondylitis and Tennis Elbow, sponsored by Chang Gung Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-11-04.
Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Treatment
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
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.
284 studies on the registry are indexed under Tennis Elbow; 60 are open to participants now.
This study's enrollment of 30 is below the median of 50 across 253 interventional studies indexed under Tennis Elbow.
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Exclusion Criteria:
Participants in the experimental group received radial extracorporeal shock wave therapy (rESWT) plus physical therapy for 3 weeks.
Procedure: Radial extracorporeal shock wave therapy (rESWT) · Procedure: Physical therapy
Participants in the control group received sham shockwave therapy plus physical therapy for 3 weeks.
Procedure: sham shockwave therapy · Procedure: Physical therapy
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.
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.
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.
Changes in pain intensity
Participants were asked to rate their present pain intensity, as caused by the tennis elbow, from 0-10 using the Visual Analogue Scale (VAS). If participants had bilateral tennis elbow, the side with the worse pain intensity was chosen for the assessment.
Time frame: At baseline, 6 weeks, 12 weeks and 24 weeks
Changes in grip strength
Maximal grip strength of the involved arm was assessed using a grip strength dynamometer. Participants were asked to grip the dynamometer 3 times, at 15- second rest intervals, and the highest grip strength number was recorded.
Time frame: At baseline, 6 weeks, 12 weeks and 24 weeks
Changes in upper limb function
Upper extremity disability and symptoms were assessed using the Taiwan version Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire.
Time frame: At baseline, 6 weeks, 12 weeks and 24 weeks
Changes in stiffness of common extensor tendon
The changes in stiffness of common extensor tendon were assessed with sonoelastography. The images of sonoelastography were interpreted with the modified RTS scoring system and analyzed with color histogram.
Time frame: At baseline, 6 weeks, 12 weeks and 24 weeks
Changes in size of tear within common extensor tendon
On the 2-D image, the common extensor tendon was located. If there was tear within common extensor tendon, diameters in the 3-D dimension were measured and the size of the tear was calculated as a spheroid.
Time frame: At baseline, 6 weeks, 12 weeks and 24 weeks
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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Chang Gung Memorial Hospital