NCT07468734

Brief Summary

This study aims to compare the effectiveness of extracorporeal shock wave therapy (ESWT) versus structured therapeutic exercise in patients with chronic knee osteoarthritis (KOA), with respect to pain reduction and improvement of knee function.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress35%
Mar 2026Nov 2026

First Submitted

Initial submission to the registry

March 9, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

March 18, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

9 months

First QC Date

March 9, 2026

Last Update Submit

March 18, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in pain intensity

    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 Outcomes (4)

  • Stiffness assessment

    5-week after intervention

  • Assessment of physical function

    5-week after intervention

  • Knee range of motion

    5-week after intervention

  • Incidence of adverse events

    5-week after intervention

Study Arms (2)

ESWT Group

EXPERIMENTAL

Patients will receive extracorporeal shock wave therapy.

Other: Extracorporeal shock wave therapy

Exercise Therapy Group

ACTIVE COMPARATOR

Patients will undergo a structured exercise therapy program.

Other: Exercise therapy program

Interventions

Patients will receive extracorporeal shock wave therapy.

ESWT Group

Patients will undergo a structured exercise therapy program.

Exercise Therapy Group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Prior knee surgery within last 6 months.
  • Intra-articular injections in the last 3 months.
  • Systemic inflammatory arthritis or other neurological conditions affecting gait.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

German International University

Cairo, 12613, Egypt

RECRUITING

MeSH Terms

Interventions

Extracorporeal Shockwave Therapy

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitation

Central Study Contacts

Magdy M Shabana, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor in Orthopedic, Physical Therapy

Study Record Dates

First Submitted

March 9, 2026

First Posted

March 13, 2026

Study Start

March 18, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations