Effectiveness of Radial Extracorporeal Shockwave Therapy on Tennis Elbow
- Conditions
- Lateral EpicondylosisTennis ElbowLateral Epicondylitis
- Interventions
- Procedure: Radial extracorporeal shock wave therapy (rESWT)Procedure: sham shockwave therapyProcedure: Physical therapy
- Registration Number
- NCT02596659
- Lead Sponsor
- Chang Gung Memorial Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description The experimental group Physical therapy Participants in the experimental group received radial extracorporeal shock wave therapy (rESWT) plus physical therapy for 3 weeks. The experimental group Radial extracorporeal shock wave therapy (rESWT) Participants in the experimental group received radial extracorporeal shock wave therapy (rESWT) plus physical therapy for 3 weeks. The control group sham shockwave therapy Participants in the control group received sham shockwave therapy plus physical therapy for 3 weeks. The control group Physical therapy Participants in the control group received sham shockwave therapy plus physical therapy for 3 weeks.
- Primary Outcome Measures
Name Time Method Changes in upper limb function 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 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.
Changes in grip strength 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 pain intensity 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.
- Secondary Outcome Measures
Name Time Method Changes in size of tear within common extensor tendon 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.
Trial Locations
- Locations (1)
Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung city, Taiwan