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
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
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
NCT ID
NCT02596659
First Posted
October 22, 2015
Last Updated
November 3, 2015
Sponsor
Chang Gung Memorial Hospital
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:
PubMed Identifier
18677489
Citation
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19542412
Citation
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Results Reference
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PubMed Identifier
22495685
Citation
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Results Reference
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PubMed Identifier
24758665
Citation
Ahn KS, Kang CH, Hong SJ, Jeong WK. Ultrasound elastography of lateral epicondylosis: clinical feasibility of quantitative elastographic measurements. AJR Am J Roentgenol. 2014 May;202(5):1094-9. doi: 10.2214/AJR.13.11003.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
Spacca G, Necozione S, Cacchio A. Radial shock wave therapy for lateral epicondylitis: a prospective randomised controlled single-blind study. Eura Medicophys. 2005 Mar;41(1):17-25.
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Citation
Gunduz R, Malas FU, Borman P, Kocaoglu S, Ozcakar L. Physical therapy, corticosteroid injection, and extracorporeal shock wave treatment in lateral epicondylitis. Clinical and ultrasonographical comparison. Clin Rheumatol. 2012 May;31(5):807-12. doi: 10.1007/s10067-012-1939-y. Epub 2012 Jan 27.
Results Reference
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Effectiveness of Radial Extracorporeal Shockwave Therapy on Tennis Elbow
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