NCT04243135

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
Last Updated

January 29, 2020

Status Verified

January 1, 2020

Enrollment Period

1.6 years

First QC Date

January 21, 2020

Last Update Submit

January 27, 2020

Conditions

Orthopedic Disorder

Keywords

r-ESWTknee osteoarthritispainfunction

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 20-meter walk test

    change from baseline on walking speed

    up to 12 weeks

  • 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

Study Arms (2)

ESWT group

ACTIVE COMPARATOR

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

Sham-ESWT group

SHAM COMPARATOR

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

Interventions

ESWTDEVICE

Extracorporeal shock wave therapy

ESWT groupSham-ESWT group

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mustafa Kemal University

Hatay, Turkey (Türkiye)

Location

Related Publications (1)

  • Uysal A, Yildizgoren MT, Guler H, Turhanoglu AD. Effects of radial extracorporeal shock wave therapy on clinical variables and isokinetic performance in patients with knee osteoarthritis: a prospective, randomized, single-blind and controlled trial. Int Orthop. 2020 Jul;44(7):1311-1319. doi: 10.1007/s00264-020-04541-w. Epub 2020 Mar 26.

    PMID: 32215674DERIVED

MeSH Terms

Conditions

Musculoskeletal DiseasesOsteoarthritis, KneePain

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alper Uysal, MD

    Mustafa Kemal University Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Clinical Assoc. Professor

Study Record Dates

First Submitted

January 21, 2020

First Posted

January 28, 2020

Study Start

January 1, 2018

Primary Completion

August 1, 2019

Study Completion

December 1, 2019

Last Updated

January 29, 2020

Record last verified: 2020-01

Locations

TU(1)