Lateral EpicondylosisNCT02596659
Effectiveness of Radial Extracorporeal Shockwave Therapy on Tennis Elbow
A study testing Radial extracorporeal shock wave therapy (rESWT) and Physical therapy in people with Lateral Epicondylosis and Lateral Epicondylitis, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lateral Epicondylosis, Lateral Epicondylitis, Tennis Elbow
- What is being tested?
- Radial extracorporeal shock wave therapy (rESWT) and Physical therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2013to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833
About this study
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.
Read more
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
- Being tested
- Radial extracorporeal shock wave therapy (rESWT), sham shockwave therapy, Physical therapy
- Keywords
- lateral epicondylosis, lateral epicondylitis, shockwave, sonoelastography, tennis elbow, pain intensity, grip strength, upper limb function, stiffness of common extensor tendon
- Medical subject headings
- Tennis Elbow, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial extracorporeal shock wave therapy (rESWT)Procedure or surgery
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 therapyProcedure or surgery
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.
Physical therapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| The experimental group | Experimental | Participants in the experimental group received radial extracorporeal shock wave therapy (rESWT) plus physical therapy for 3 weeks. Receives: Procedure: Radial extracorporeal shock wave therapy (rESWT); Procedure: Physical therapy |
| The control group | Sham comparator | Participants in the control group received sham shockwave therapy plus physical therapy for 3 weeks. Receives: Procedure: sham shockwave therapy; Procedure: Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline, 6 weeks, 12 weeks and 24 weeks
Secondary outcomes (1)
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.
Measured: At baseline, 6 weeks, 12 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
- Study startSep 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Lateral EpicondylosisStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tsung-Hsun Yang, MD, Principal investigator, Kaohsiung Chang Cung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02596659
- Sponsor's protocol ID
- RESWTonLE201309
- Status last verified
- Oct 2015
- First submitted
- 22 Oct 2015
- Last updated
- 4 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Khoury V, Cardinal E. "Tenomalacia": a new sonographic sign of tendinopathy? Eur Radiol. 2009 Jan;19(1):144-6. doi: 10.1007/s00330-008-1112-9. Epub 2008 Aug 2.
PubMed 18677489De Zordo T, Lill SR, Fink C, Feuchtner GM, Jaschke W, Bellmann-Weiler R, Klauser AS. Real-time sonoelastography of lateral epicondylitis: comparison of findings between patients and healthy volunteers. AJR Am J Roentgenol. 2009 Jul;193(1):180-5. doi: 10.2214/AJR.08.2020.
PubMed 19542412Kwon DR, Park GY, Lee SU, Chung I. Spastic cerebral palsy in children: dynamic sonoelastographic findings of medial gastrocnemius. Radiology. 2012 Jun;263(3):794-801. doi: 10.1148/radiol.12102478. Epub 2012 Apr 10.
PubMed 22495685Ahn 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.
PubMed 24758665Speed C. A systematic review of shockwave therapies in soft tissue conditions: focusing on the evidence. Br J Sports Med. 2014 Nov;48(21):1538-42. doi: 10.1136/bjsports-2012-091961. Epub 2013 Aug 5.
PubMed 23918444Spacca 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.
PubMed 16175767Ilieva EM, Minchev RM, Petrova NS. Radial shock wave therapy in patients with lateral epicondylitis. Folia Med (Plovdiv). 2012 Jul-Sep;54(3):35-41. doi: 10.2478/v10153-011-0095-5.
PubMed 23270205Gunduz 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.
PubMed 22278162
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Radial Extracorporeal Shockwave Therapy on Tennis Elbow
- ClinicalTrials.gov ID
- NCT02596659
- Acronym / sponsor ID
- RESWTonLE201309
- Conditions
- Lateral Epicondylosis, Lateral Epicondylitis, Tennis Elbow
- Keywords
- lateral epicondylosis, lateral epicondylitis, shockwave, sonoelastography, tennis elbow, pain intensity, grip strength, upper limb function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 4 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The experimental group | Experimental | Procedure: Radial extracorporeal shock wave therapy (rESWT), Procedure: Physical therapyParticipants in the experimental group received radial extracorporeal shock wave therapy (rESWT) plus physical therapy for 3 weeks. |
| The control group | Sham comparator | Procedure: sham shockwave therapy, Procedure: Physical therapyParticipants in the control group received sham shockwave therapy plus physical therapy for 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | The experimental group |
| sham shockwave therapySham 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 or surgery | The control group |
| Physical therapyThe 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 or surgery | The control group, The experimental group |
Primary outcome
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.
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.
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.
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.
1 secondary outcome
Changes in size of tear within common extensor tendon
Time frame: At baseline, 6 weeks, 12 weeks and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2015.
- Background: PubMed 18677489Khoury V, Cardinal E. "Tenomalacia": a new sonographic sign of tendinopathy? Eur Radiol. 2009 Jan;19(1):144-6. doi: 10.1007/s00330-008-1112-9. Epub 2008 Aug 2.
- Background: PubMed 19542412De Zordo T, Lill SR, Fink C, Feuchtner GM, Jaschke W, Bellmann-Weiler R, Klauser AS. Real-time sonoelastography of lateral epicondylitis: comparison of findings between patients and healthy volunteers. AJR Am J Roentgenol. 2009 Jul;193(1):180-5. doi: 10.2214/AJR.08.2020.
- Background: PubMed 22495685Kwon DR, Park GY, Lee SU, Chung I. Spastic cerebral palsy in children: dynamic sonoelastographic findings of medial gastrocnemius. Radiology. 2012 Jun;263(3):794-801. doi: 10.1148/radiol.12102478. Epub 2012 Apr 10.
- Background: PubMed 24758665Ahn 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.
- Background: PubMed 23918444Speed C. A systematic review of shockwave therapies in soft tissue conditions: focusing on the evidence. Br J Sports Med. 2014 Nov;48(21):1538-42. doi: 10.1136/bjsports-2012-091961. Epub 2013 Aug 5.
- Background: PubMed 16175767Spacca 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.
- Background: PubMed 23270205Ilieva EM, Minchev RM, Petrova NS. Radial shock wave therapy in patients with lateral epicondylitis. Folia Med (Plovdiv). 2012 Jul-Sep;54(3):35-41. doi: 10.2478/v10153-011-0095-5.
- Background: PubMed 22278162Gunduz 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tsung-Hsun Yang, MD principal investigator
Kaohsiung Chang Cung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radial extracorporeal shock wave therapy (rESWT) and Physical therapy in people with Lateral Epicondylosis and Lateral Epicondylitis, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in pain intensity (time frame: At baseline, 6 weeks, 12 weeks and 24 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02596659, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2015.