NCT07567365

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
12mo left

Started Sep 2027

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 5, 2026

Completed
1.4 years until next milestone

Study Start

First participant enrolled

September 25, 2027

Expected
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2028

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2028

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

9 months

First QC Date

April 28, 2026

Last Update Submit

April 28, 2026

Conditions

Knee Osteoarthristis

Keywords

Knee OsteoarthritisFocused ShockwavePulse Wave

Outcome Measures

Primary Outcomes (1)

  • Change in WOMAC Pain Subscale score from baseline to the primary endpoint - likely 8 or 12 weeks after treatment begins.

    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

Study Arms (2)

Physical Rehab Group

ACTIVE COMPARATOR

Participants in this arm will receive physical rehab only for at the same frequency and duration as the comparator group.

Other: Physical Rehab

Focused Shockwave Therapy Group

ACTIVE COMPARATOR

This arm will receive focused shockwave therapy at the same frequency and duration as the comparator group.

Device: Focused Shockwave Therapy

Interventions

Physical RehabOTHER

Physical rehab through the use of body weight exercises, resistance bands, weights, movement, repetitive movement.

Also known as: Physical Therapy
Physical Rehab Group
Focused Shockwave TherapyDEVICE

Applying focused shockwave therapy using a focused shockwave therapy device to the treatment area.

Focused Shockwave Therapy Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Westminster Spine & Injury Center

Westminster, Colorado, 80021, United States

Location

Related Publications (4)

  • Avendano-Coy J, Comino-Suarez N, Grande-Munoz J, Avendano-Lopez C, Gomez-Soriano J. Extracorporeal shockwave therapy improves pain and function in subjects with knee osteoarthritis: A systematic review and meta-analysis of randomized clinical trials. Int J Surg. 2020 Oct;82:64-75. doi: 10.1016/j.ijsu.2020.07.055. Epub 2020 Aug 13.

    PMID: 32798759BACKGROUND

  • Covelli I, De Giorgi S, Di Lorenzo A, Pavone A, Salvato F, Rifino F, Moretti B, Solarino G, Notarnicola A. Extracorporeal Shock Wave Therapy (ESWT) vs. Exercise in Thumb Osteoarthritis (SWEX-TO): Prospective Clinical Trial at 6 Months. Life (Basel). 2024 Nov 8;14(11):1453. doi: 10.3390/life14111453.

    PMID: 39598251BACKGROUND

  • Liao PC, Chou SH, Shih CL. A systematic review of the use of shockwave therapy for knee osteoarthritis. J Orthop. 2024 May 1;56:18-25. doi: 10.1016/j.jor.2024.04.020. eCollection 2024 Oct.

    PMID: 38765896BACKGROUND

  • Uysal A, Yildizgoren MT, Guler H, Turhanoglu AD. Effects of radial extracorporeal shock wave therapy on clinical variables and isokinetic performance in patients with knee osteoarthritis: a prospective, randomized, single-blind and controlled trial. Int Orthop. 2020 Jul;44(7):1311-1319. doi: 10.1007/s00264-020-04541-w. Epub 2020 Mar 26.

    PMID: 32215674BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Cameron A Hall, DC, PhD

    Pulse Wave USA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cameron A Hall, DC, PhD

CONTACT

720-518-8005drhall@pulse-wave.us

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 28, 2026

First Posted

May 5, 2026

Study Start (Estimated)

September 25, 2027

Primary Completion (Estimated)

June 25, 2028

Study Completion (Estimated)

September 25, 2028

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Patient privacy and HIPAA.

Locations

US(1)