Extracorporeal Shock Wave Therapy in Osteoarthritis

December 13, 2023 updated by: Masood Khan, King Saud University

Effectiveness of Extracorporeal Shock Wave Therapy on Improving Functional Ability in Knee Osteoarthritis (Grade iv)

The present study has examined the effectiveness of extracorporeal shock wave therapy along with conventional physical therapy on functional ability in grade IV knee osteoarthritis. Intervention program was performed for four weeks. Conventional physical therapy included ultrasound therapy, isometric quadriceps, straight leg raising (SLR) and isometric hip adductor strengthening exercises. Functional ability was assessed using the Lower Extremity Functional Scale (LEFS) score.

Study Overview

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Riyadh, Saudi Arabia, 11433
        • King Saud University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Grade IV primary knee Osteoarthritis (OA) diagnosed by an orthopaedic surgeon based on the Kellgren-Lawrence score

Exclusion Criteria:

  • Secondary knee OA,
  • rheumatoid arthritis,
  • psoriatic arthritis,
  • the presence of any red flags (metastatic growth, thrombophlebitis),
  • neurologic or psychiatric impairments,
  • tissue injuries of the knee joint,
  • previous knee joint replacement or other surgeries in the knee joint,
  • already received ESWT,
  • Intra articular injection
  • unable to walk independently

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
The participants in this group received Extracorporeal Shock Wave Therapy (ESWT) in addition to conventional physical therapy.
The ESWT was performed by an ESWT instrument (Chattanooga) once a week for four consecutive weeks (a total of four sessions).
Conventional physical therapy consisted of ultrasound therapy and three types of knee-strengthening exercises.
Active Comparator: Control group
The participants in this group received conventional physical therapy only.
Conventional physical therapy consisted of ultrasound therapy and three types of knee-strengthening exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lower Extremity Functional Scale (LEFS) score
Time Frame: 4 weeks
It is a measurement tool used to assess the functional status and ability of individuals with lower extremity musculoskeletal conditions or injuries. The LEFS consists of 20 items and each item is rated on a scale from 0 to 4, with 0 indicating extreme difficulty to perform the activity and 4 indicating no difficulty at all. The scores for all items are summed to obtain a total score ranging from 0 to 80.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Masood Khan, MPTh, King Saud University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2021

Primary Completion (Actual)

February 2, 2022

Study Completion (Actual)

April 27, 2022

Study Registration Dates

First Submitted

December 13, 2023

First Submitted That Met QC Criteria

December 13, 2023

First Posted (Actual)

December 26, 2023

Study Record Updates

Last Update Posted (Actual)

December 26, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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