- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07468734
Shock Wave Versus Traditional Physical Therapy for Adult Chronic Knee Osteoarthritis
Shock Wave Versus Traditional Physical Therapy for Adult Chronic Knee Osteoarthritis: A Prospective Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Knee osteoarthritis (KOA) is a highly prevalent chronic degenerative joint disease characterized by progressive cartilage loss, chronic pain, stiffness, functional disability, and reduced quality of life in adults, particularly the elderly.
Extracorporeal shock wave therapy (ESWT) has emerged as a non-invasive physical modality that delivers acoustic pressure waves to musculoskeletal tissues, stimulating biological responses such as enhanced microcirculation, anti-inflammatory cytokine modulation, neovascularization, cartilage and bone repair processes, and decreased pain transmission.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Magdy M Shabana, MD
- Phone Number: 00201006053332
- Email: magdy.shabana@giu-uni.de
Study Locations
-
-
-
Cairo, Egypt, 12613
- Recruiting
- German International University
-
Contact:
- Magdy M Shabana, MD
- Phone Number: 00201006053332
- Email: magdy.shabana@giu-uni.de
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults ≥ 40 years with clinical and radiographic diagnosis of chronic knee osteoarthritis (KOA) (Kellgren-Lawrence grade II-III).
- Both sexes.
- Persistent knee pain ≥ 3 months.
- Ability to provide consent and participate in interventions.
Exclusion Criteria:
- Prior knee surgery within last 6 months.
- Intra-articular injections in the last 3 months.
- Systemic inflammatory arthritis or other neurological conditions affecting gait.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ESWT Group
Patients will receive extracorporeal shock wave therapy.
|
Patients will receive extracorporeal shock wave therapy.
|
|
Active Comparator: Exercise Therapy Group
Patients will undergo a structured exercise therapy program.
|
Patients will undergo a structured exercise therapy program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in pain intensity
Time Frame: 5-week after intervention
|
Change in pain intensity will be assessed using the Visual Analogue Scale (VAS) which is a 10-cm horizontal line used to measure pain intensity, ranging from (0) "no pain" to (10) "worst imaginable pain".
|
5-week after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stiffness assessment
Time Frame: 5-week after intervention
|
Stiffness will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). WOMAC will be recorded at baseline, at the end of the intervention period, and during follow-up. Higher scores indicate greater symptom severity. |
5-week after intervention
|
|
Assessment of physical function
Time Frame: 5-week after intervention
|
Physical function will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). WOMAC will be recorded at baseline, at the end of the intervention period, and during follow-up. Higher scores indicate greater symptom severity. |
5-week after intervention
|
|
Knee range of motion
Time Frame: 5-week after intervention
|
Knee range of motion (ROM) will be assessed.
|
5-week after intervention
|
|
Incidence of adverse events
Time Frame: 5-week after intervention
|
Incidence of adverse events will be recorded.
|
5-week after intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DCSR-02026-104
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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-
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