Clinical Outcomes of Focused Shockwave Therapy Without Adjunct Rehabilitation Compared to Standard Physical Rehabilitation in Patients With Grade I-III Knee Osteoarthritis: A Single-Blind Randomized Study

April 28, 2026 updated by: Cameron Hall, Pulse Wave USA
Clinical Outcomes of Focused Shockwave Therapy Without Adjunct Rehabilitation Compared to Standard Physical Rehabilitation in Patients with Grade I-III Knee Osteoarthritis: A Single-Blind Randomized Study

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

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 Contact

Study Locations

  • United States
    • Colorado
      • Westminster, Colorado, United States, 80021
        • Westminster Spine & Injury Center
        • Contact:

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient must have diagnosed OA of the unilateral or bilateral knee(s) sufficient to qualify as grade I, II, or III O.A.

Exclusion Criteria:

  • Patients without diagnosable or gradable O.A. of the knee or knees.

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
Active Comparator: Physical Rehab Group
Participants in this arm will receive physical rehab only for at the same frequency and duration as the comparator group.
Other: Physical Rehab
Physical rehab through the use of body weight exercises, resistance bands, weights, movement, repetitive movement.
Other Names:
  • Physical Therapy
Active Comparator: Focused Shockwave Therapy Group
This arm will receive focused shockwave therapy at the same frequency and duration as the comparator group.
Device: Focused Shockwave Therapy
Applying focused shockwave therapy using a focused shockwave therapy device to the treatment area.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in WOMAC Pain Subscale score from baseline to the primary endpoint - likely 8 or 12 weeks after treatment begins.
Time Frame: 8 to 12 weeks
The primary outcome measure will be the between-group difference in change from baseline in WOMAC Pain Subscale score at 12 weeks.
8 to 12 weeks

Collaborators and Investigators

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

Sponsor

Pulse Wave USA

Investigators

  • Principal Investigator: Cameron A Hall, DC, PhD, Pulse Wave USA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

September 25, 2027

Primary Completion (Estimated)

June 25, 2028

Study Completion (Estimated)

September 25, 2028

Study Registration Dates

First Submitted

April 28, 2026

First Submitted That Met QC Criteria

April 28, 2026

First Posted (Actual)

May 5, 2026

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IKOABS1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Patient privacy and HIPAA.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

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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