Extracorporeal Focused Shock Wave Therapy for Primary Knee Osteoarthritis

University of Sao Paulo General Hospital

Status and phase: Unknown; Phase 2

Conditions: Unilateral Primary Osteoarthritis of Knee

Treatments: Device: Extracorporeal Shock Waves; Other: Physical activities; Device: Sham Extracorporeal Shock Waves

Study type: Interventional

Funder types: Other

Identifiers

NCT02904785

54013616.1.0000.0068

Details and patient eligibility

About

The purpose of this study is to determine whether Extracorporeal Focused Shock Wave Therapy reduces knee pain and enhance function in patients with primary knee osteoarthritis.

Full description

This study is a placebo controlled Randomized Clinical Trial (RCT) in which the primary outcome is to determine whether Extracorporeal Focused Shock Wave Therapy (ESWT) reduces knee pain comparing the VAS at baseline and one month after the end of the treatment. Function assessment and progression of pain along the treatment are the secondary outcomes. Function will be assessed with the Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC), the Lequesne's Algofunctional Questionnaire for Osteoarthritis of Knee (Lequesne) and the Timed up and Go (TUG).

The ESWT applications will be performed once a week for four consecutive weeks, the patients will be assessed for pain and function before the beginning of the treatment and one week after every application of the ESWT.

The treatment groups will be randomized. The allocation of the patients is sealed and will not be disclosed to the patients nor to the evaluators.

Enrollment: 30 estimated patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical and radiologic diagnosis of primary knee osteoarthritis (Kellgren & Lawrence I, II or III);
• Capability to understand the Informed Consent Form;
• Chronic pain for at least 3 months prior to inclusion, measured by VAS. (VAS 4 or above);
• Absence of skin injures, infections or tumor in the target knee;
• Availability to comply with the visits.

Exclusion criteria

• History of spinal cord stenosis or clinical symptoms of lumbar radiculopathy;
• History or onset neurological diseases;
• Generalized pain or fibromyalgia;
• Inability to walk;
• History of knee surgery in the target knee;
• Secondary causes of osteoarthritis;
• Use of statins and quinolones in the previous year;
• Uncontrolled and ongoing psychiatric diseases;
• Invasive knee treatments with hyaluronic acid infusion, corticosteroids and anaesthetics, in the target knee, up to 6 months previous to study inclusion.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

Extracorporeal Shock Waves

Experimental group

Description:

Focused shock waves delivered by an electromagnetic generator with a focus of 5.0cm deep on the affected knee in three different positions. A total of 7000 pulses will be delivered on a weekly session for four weeks.

Treatment:

Other: Physical activities

Device: Extracorporeal Shock Waves

Sham Extracorporeal Shock Waves

Sham Comparator group

Description:

Sham focused shock waves delivered by an electromagnetic generator on the affected knee in three different positions. A total of 7000 pulses will be delivered on a weekly session for four weeks. A foam will be placed in the probe as to stop the energy to be transmitted to the patient's knee, so no focused shockwaves will be delivered.

Treatment:

Other: Physical activities

Device: Sham Extracorporeal Shock Waves