Extracorporeal Focused Shock Wave Therapy for Primary Knee Osteoarthritis

NCT ID: NCT02904785

Last Updated: 2016-09-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2016-12-31

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.

Conditions

Unilateral Primary Osteoarthritis of Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Extracorporeal Shock Waves

Intervention Type: DEVICE

Physical activities

Intervention Type: OTHER

Patients receive instructions for physical activities for strengthening of femoral quadriceps and stretching of hamstring muscles.

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.

Group Type: SHAM_COMPARATOR

Sham Extracorporeal Shock Waves

Intervention Type: DEVICE

Physical activities

Intervention Type: OTHER

Patients receive instructions for physical activities for strengthening of femoral quadriceps and stretching of hamstring muscles.

Interventions

Extracorporeal Shock Waves

Intervention Type: DEVICE

Sham Extracorporeal Shock Waves

Intervention Type: DEVICE

Physical activities

Patients receive instructions for physical activities for strengthening of femoral quadriceps and stretching of hamstring muscles.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Linamara Rizzo Battistella, MD PhD

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Linamara R Battistella, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

Centro de Pesquisa Clínica do Instituto de Medicina Física e Reabilitação do HCFMUSP

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Gilson T Shinzato, MD

Role: CONTACT

g.shinzato@hc.fm.usp.br

55-11-99688-0698

Fabíola Cavalieri, MD

Role: CONTACT

fabiola.cavalieri@hc.fm.usp.br

55-11-99212-3999

Facility Contacts

Fabíola Cavalieri, MD

Role: primary

fabiola.cavalieri@hc.fm.usp.br

55-11-99212-3999

Artur C Santos

Role: backup

artur.santos@hc.fm.usp.br

55-11-5180-7897

Other Identifiers

54013616.1.0000.0068

Identifier Type: -

Identifier Source: org_study_id