r-ESWT in Moderate Knee Osteoarthritis

Orthopedic Disorder Clinical Trial

Official title:

Effects of Radial Extracorporeal Shock Wave Therapy (r-ESWT) on Clinical Variables and Isokinetic Performance in Patients With Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04243135
• Other study ID #: Protocol Code: 2017/166
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: January 2020
• Source: Mustafa Kemal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Orthopedic Disorder
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• ESWT
Extracorporeal shock wave therapy

Locations

Country	Name	City	State
Turkey	Mustafa Kemal University	Hatay

Sponsors (1)

Lead Sponsor	Collaborator
Mustafa Kemal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale (VAS)	The VAS is used to measure and monitor pain intensity. Scores range from the absence of pain (0) to intolerable pain (0 or 10)	up to 12 weeks
Primary	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	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).	up to 12 weeks
Primary	20-meter walk test	change from baseline on walking speed	up to 12 weeks
Primary	isokinetic muscle performance	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.	up to 12 weeks