- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06181955
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
Status
Completed
Conditions
Intervention / Treatment
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
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Riyadh, Saudi Arabia, 11433
- King Saud University
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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.
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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.
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Active Comparator: Control group
The participants in this group received conventional physical therapy only.
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Conventional physical therapy consisted of ultrasound therapy and three types of knee-strengthening exercises.
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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.
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4 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AWH/EC/03/2021/2
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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