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r-ESWT in Moderate Knee Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04243135
Recruitment Status : Completed
First Posted : January 28, 2020
Last Update Posted : January 29, 2020
Sponsor:
Information provided by (Responsible Party):
Mustafa Turgut Yildizgoren, 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.

Condition or disease Intervention/treatment Phase
Orthopedic Disorder Device: ESWT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis Shock

Arm Intervention/treatment
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)).
Device: ESWT
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.
Device: ESWT
Extracorporeal shock wave therapy




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243135


Locations
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Turkey
Mustafa Kemal University
Hatay, Turkey
Sponsors and Collaborators
Mustafa Kemal University
Investigators
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Principal Investigator: Alper Uysal, MD Mustafa Kemal University Medical School
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mustafa Turgut Yildizgoren, Principal Investigator, Clinical Assoc. Professor, Mustafa Kemal University
ClinicalTrials.gov Identifier: NCT04243135    
Other Study ID Numbers: Protocol Code: 2017/166
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Mustafa Turgut Yildizgoren, Mustafa Kemal University:
r-ESWT
knee osteoarthritis
pain
function
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Musculoskeletal Diseases
Arthritis
Joint Diseases
Rheumatic Diseases