Effectiveness of Radial Extracorporeal Shockwave Therapy on Tennis Elbow

Lateral Epicondylitis Clinical Trial

Official title:

Effectiveness of Radial Extracorporeal Shockwave Therapy on Tennis Elbow

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02596659
• Other study ID #: RESWTonLE201309
• Status: Completed
• Phase: N/A
• First received: October 22, 2015
• Last updated: November 3, 2015
• Start date: September 2013
• Est. completion date: May 2015

Study information

• Verified date: October 2015
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lateral Epicondylitis
• Lateral Epicondylosis
• Tennis Elbow

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Taiwan	Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital	Kaohsiung city

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (8)

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. — View Citation

De 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. — View Citation

Gündüz R, Malas FÜ, Borman P, Kocaoglu S, Özçakar 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. — View Citation

Ilieva EM, Minchev RM, Petrova NS. Radial shock wave therapy in patients with lateral epicondylitis. Folia Med (Plovdiv). 2012 Jul-Sep;54(3):35-41. — View Citation

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. — View Citation

Kwon 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. — View 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. — View Citation

Speed 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At baseline, 6 weeks, 12 weeks and 24 weeks	No
Primary	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.	At baseline, 6 weeks, 12 weeks and 24 weeks	No
Primary	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.	At baseline, 6 weeks, 12 weeks and 24 weeks	No
Primary	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.	At baseline, 6 weeks, 12 weeks and 24 weeks	No
Secondary	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.	At baseline, 6 weeks, 12 weeks and 24 weeks	No