r-ESWT in Moderate Knee Osteoarthritis

Not Applicable

Completed

• Conditions: Orthopedic Disorder
• Interventions: Device: ESWT

• Registration Number: NCT04243135
• Lead Sponsor: Mustafa Kemal University

Brief Summary

This study aims to compare the efficacy of r-ESWT treatment with sham-ESWT on pain, walking speed, physical function, and isokinetic muscle strength in knee osteoarthritis.

Detailed Description

Extracorporeal shock wave therapy (ESWT) has been increasingly used to help relieve pain and to remedy musculoskeletal disorders in recent years. ESWT seems to be an effective treatment modality many different musculoskeletal conditions, including rotator cuff tendinopathies, calcifying tendinopathy of the shoulder, lateral epicondylitis, greater trochanteric pain syndrome, patellar tendinopathy, achilles tendinopathy, plantar fasciitis, and bone disorders. ESWT seems to have chondroprotective, anti-inflammatory, neovascularization, anti-apoptotic, and tissue regeneration effect on tissues which could be relevant in the treatment of OA.

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2019-08-01
• Study Completion: 2019-12-01
• Status Verified: 2020-01
• Study First Submitted: 2020-01-21
• Study First Submitted QC: 2020-01-23
• Last Update Submitted: 2020-01-27
• Study First Posted: 2020-01-28
• Last Update Posted: 2020-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Knee OA according to American College of Rheumatology (ACR) diagnostic criteria with Kellgren - Lawrence (K-L) grade 2 or 3.

Exclusion Criteria

• Patients with secondary OA,
• severe chronic illness,
• poor general health status (heart failure, chronic bronchitis, etc.),
• chronic inflammatory diseases,
• knee replacement surgery,
• prior malignancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham-ESWT group	ESWT	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.
ESWT group	ESWT	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)).

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS)	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)	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	up to 12 weeks	change from baseline on walking speed
isokinetic muscle performance	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.

Trial Locations

Locations (1)

Mustafa Kemal University; 🇹🇷 Hatay, Turkey