Effectiveness of Radial Extracorporeal Shockwave Therapy on Tennis Elbow

November 3, 2015 updated by: Chang Gung Memorial Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung city, Taiwan, 833
        • Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged > 18 years old
  • Lateral elbow pain lasting > 3 months
  • Pain induced by direct compression on the lateral epicondyle or common extensor tendon, resistant wrist extension and pronation in the elbow extension position, or static stretching of common extensor tendon through the palmer flexion in wrist pronation and elbow extension position

Exclusion Criteria:

  • Generalized inflammatory arthritis (e.g., rheumatic arthritis)
  • Pain at the proximal part of involved arm (e.g., shoulder pain, neck pain)
  • Pain other than elbow pain at the involved arm
  • Abnormal neurogenic symptom over the involved arm (e.g., radicular pain, hands numbness, hemiplegia)
  • Wound or skin lesion at the elbow of the involved arm
  • Pregnancy
  • Severe local or systemic infection
  • Malignancy
  • Coagulopathy
  • Cardiac pacemaker
  • History of surgical treatment at the elbow of the involved arm
  • Non-steroid anti-inflammatory drug (NSAID) use orally or topically at the elbow of the involved arm in the past week
  • Local steroid injection at the elbow of the involved arm in the past 3 months
  • Oral steroid use in the past 6 weeks
  • Refusal to sign the informed consent
  • Impairment in self-expression (e.g., dementia, aphasia)
  • Inability/unwillingness to participate in all the measurements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The experimental group
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)
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: 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.
Sham Comparator: The control group
Participants in the control group received sham shockwave therapy plus physical therapy for 3 weeks.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in pain intensity
Time Frame: At baseline, 6 weeks, 12 weeks and 24 weeks
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.
At baseline, 6 weeks, 12 weeks and 24 weeks
Changes in grip strength
Time Frame: At baseline, 6 weeks, 12 weeks and 24 weeks
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.
At baseline, 6 weeks, 12 weeks and 24 weeks
Changes in upper limb function
Time Frame: At baseline, 6 weeks, 12 weeks and 24 weeks
Upper extremity disability and symptoms were assessed using the Taiwan version Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire.
At baseline, 6 weeks, 12 weeks and 24 weeks
Changes in stiffness of common extensor tendon
Time Frame: At baseline, 6 weeks, 12 weeks and 24 weeks
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.
At baseline, 6 weeks, 12 weeks and 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in size of tear within common extensor tendon
Time Frame: At baseline, 6 weeks, 12 weeks and 24 weeks
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.
At baseline, 6 weeks, 12 weeks and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Tsung-Hsun Yang, MD, Kaohsiung Chang Cung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

October 22, 2015

First Submitted That Met QC Criteria

November 3, 2015

First Posted (Estimate)

November 4, 2015

Study Record Updates

Last Update Posted (Estimate)

November 4, 2015

Last Update Submitted That Met QC Criteria

November 3, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RESWTonLE201309

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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