Extracorporeal Focused Shock Wave Therapy for Primary Knee Osteoarthritis

Phase 2

• Conditions: Unilateral Primary Osteoarthritis of Knee
• Interventions: Device: Sham Extracorporeal Shock Waves; Device: Extracorporeal Shock Waves; Other: Physical activities

• Registration Number: NCT02904785
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-06-29
• Status Verified: 2016-09
• Study First Submitted QC: 2016-09-13
• Last Update Submitted: 2016-09-13
• Study First Posted: 2016-09-19
• Last Update Posted: 2016-09-19
• Primary Completion: 2016-10
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Extracorporeal Shock Waves	Sham Extracorporeal Shock Waves	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.
Extracorporeal Shock Waves	Physical activities	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.
Sham Extracorporeal Shock Waves	Physical activities	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.
Extracorporeal Shock Waves	Extracorporeal Shock Waves	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.

Primary Outcome Measures

Name	Time	Method
Knee Pain after one month	One month	Mean change in Visual Analogue Scale (VAS) score one month after the end of the treatment compared to baseline.

Secondary Outcome Measures

Name	Time	Method
WOMAC Knee Function after three months	Three months	Mean change in WOMAC score three months after the end of the treatment compared to baseline.
Knee pain progression	One week after each of four weekly ESWT applications	Mean change in VAS score one week after each application compared to baseline.
Knee Pain after three months	Three months	Mean change in VAS score three months after the end of the treatment compared to baseline.
Lequesne Knee Function progression	One week after each of four weekly ESWT applications	Mean change in Lequesne score one week after each application compared to baseline.
Lequesne Knee Function after three months	Three months	Mean change in Lequesne three months after the end of the treatment compared to baseline.
WOMAC Knee Function progression	One week after each of four weekly ESWT applications	Mean change in WOMAC score one week after each application compared to baseline.
TUG Knee Function progression	One week after each of four weekly ESWT applications	Mean change in TUG score one week after each application compared to baseline.
TUG Knee Function after three months	Three months	Mean change in TUG score three months after the end of the treatment compared to baseline.

Trial Locations

Locations (1)

Centro de Pesquisa Clínica do Instituto de Medicina Física e Reabilitação do HCFMUSP; 🇧🇷 Sao Paulo, Brazil