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Effectiveness of Radial Extracorporeal Shockwave Therapy on Tennis Elbow

Primary Purpose

Lateral Epicondylosis, Lateral Epicondylitis, Tennis Elbow

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Radial extracorporeal shock wave therapy (rESWT)
sham shockwave therapy
Physical therapy
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lateral Epicondylosis focused on measuring lateral epicondylosis, lateral epicondylitis, shockwave, sonoelastography, tennis elbow, pain intensity, grip strength, upper limb function, stiffness of common extensor tendon

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

The experimental group

The control group

Arm Description

Participants in the experimental group received radial extracorporeal shock wave therapy (rESWT) plus physical therapy for 3 weeks.

Participants in the control group received sham shockwave therapy plus physical therapy for 3 weeks.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 22, 2015
Last Updated
November 3, 2015
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02596659
Brief Title
Effectiveness of Radial Extracorporeal Shockwave Therapy on Tennis Elbow
Official Title
Effectiveness of Radial Extracorporeal Shockwave Therapy on Tennis Elbow
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylosis, Lateral Epicondylitis, Tennis Elbow
Keywords
lateral epicondylosis, lateral epicondylitis, shockwave, sonoelastography, tennis elbow, pain intensity, grip strength, upper limb function, stiffness of common extensor tendon

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The experimental group
Arm Type
Experimental
Arm Description
Participants in the experimental group received radial extracorporeal shock wave therapy (rESWT) plus physical therapy for 3 weeks.
Arm Title
The control group
Arm Type
Sham Comparator
Arm Description
Participants in the control group received sham shockwave therapy plus physical therapy for 3 weeks.
Intervention Type
Procedure
Intervention Name(s)
Radial extracorporeal shock wave therapy (rESWT)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
sham shockwave therapy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Physical therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in pain intensity
Description
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
Title
Changes in grip strength
Description
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
Title
Changes in upper limb function
Description
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
Title
Changes in stiffness of common extensor tendon
Description
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
Secondary Outcome Measure Information:
Title
Changes in size of tear within common extensor tendon
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tsung-Hsun Yang, MD
Organizational Affiliation
Kaohsiung Chang Cung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung city
ZIP/Postal Code
833
Country
Taiwan

12. IPD Sharing Statement

Citations:
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18677489
Citation
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Effectiveness of Radial Extracorporeal Shockwave Therapy on Tennis Elbow

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