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NCT Number: NCT07567365

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

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

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Westminster Spine & Injury Center

Westminster, Colorado, 80021, United States

Location contact

CAMERON HALL

CONTACT

[email protected]

3034259557

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physical Rehab

Other

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

Other names: Physical Therapy

Focused Shockwave Therapy

Device

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

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cameron A Hall, DC, PhD

CONTACT

[email protected]

720-518-8005

Sponsors and collaborators

Lead sponsor

Pulse Wave USA

Industry

Registry information

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
May 5, 2026
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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