r-ESWT in Moderate Knee Osteoarthritis
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|ClinicalTrials.gov Identifier: NCT04243135|
Recruitment Status : Completed
First Posted : January 28, 2020
Last Update Posted : January 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|Orthopedic Disorder||Device: ESWT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Effects of Radial Extracorporeal Shock Wave Therapy (r-ESWT) on Clinical Variables and Isokinetic Performance in Patients With Knee Osteoarthritis|
|Actual Study Start Date :||January 1, 2018|
|Actual Primary Completion Date :||August 1, 2019|
|Actual Study Completion Date :||December 1, 2019|
Active Comparator: ESWT group
All patients in both groups were applied with a hot pack for 40-minutes, transcutaneous electrical nerve stimulation for 30-minutes (100 Hz frequency and 60 milliseconds pulse duration), and a home-based exercise program around the knee for 30-minutes per day for three weeks. Also, each patient in group 1 received shockwaves of continuous frequency and intensity (2000 shocks, 10 Hz, 2.0 to 3.0 bar), while the second group of patients received sham-ESWT. In group 1, for a total of 3 weeks, r-ESWT was undertaken with 2000 pulse each time at a week interval totaling 6000 pulse by using a radial shock wave therapy system (vibrolith ortho tip ESWT (ELMED Turkey)).
Extracorporeal shock wave therapy
Sham Comparator: Sham-ESWT group
The other group received sham-ESWT at 0.1 bar in the same area. The patients were placed supine with the affected knee at 90 degrees flexion at each treatment session. The shock wave probe was held stationary on painful points around the knee or at the patellofemoral and tibiofemoral borders of the target knee.
Extracorporeal shock wave therapy
- Visual Analog Scale (VAS) [ Time Frame: up to 12 weeks ]The VAS is used to measure and monitor pain intensity. Scores range from the absence of pain (0) to intolerable pain (0 or 10)
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: up to 12 weeks ]Pain, joint stiffness, and physical functions were evaluated by the Western Ontario and McMaster Osteoarthritis Index (WOMAC). The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68).
- 20-meter walk test [ Time Frame: up to 12 weeks ]change from baseline on walking speed
- isokinetic muscle performance [ Time Frame: up to 12 weeks ]Isokinetic muscle performance was measured using a calibrated isokinetic test device named Humac®/NormTM Testing & Rehabilitation System (Computer Sports Medicine Inc. Stoughton, MA, USA). The knee extensor/flexor muscle group isokinetic muscle strength [peak torque (PT)] of both groups was evaluated using a calibrated isokinetic dynamometer.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243135
|Mustafa Kemal University|
|Principal Investigator:||Alper Uysal, MD||Mustafa Kemal University Medical School|