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 statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorPulse Wave USA

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Physical Rehab

    Other intervention

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

  • Focused Shockwave Therapy

    Device

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Physical Rehab GroupActive comparator 1 intervention
Group B: Focused Shockwave Therapy GroupActive comparator 1 intervention

Trial outcomes

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.

Time frame
8 to 12 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: