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Completed

NCT Number: NCT04243135

r-ESWT in Moderate Knee Osteoarthritis

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.

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Key information

Conditions

Orthopedic Disorder Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Osteoarthritis, Knee Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mustafa Kemal University

Hatay, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ESWT

Device

Extracorporeal shock wave therapy

Primary outcomes

  1. 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)

  2. 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).

  3. 20-meter walk test

    Time frame: up to 12 weeks

    change from baseline on walking speed

  4. 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.

Sponsors and collaborators

Lead sponsor

Mustafa Kemal University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 28, 2020
Registry last updated
Jan 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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