Extracorporeal Focused Shock Wave Therapy for Primary Knee Osteoarthritis

The Efficacy of Extracorporeal Focused Shock Wave Therapy for Patients With Primary Knee Osteoarthritis

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.

Study Overview

• Status: Unknown
• Conditions: Unilateral Primary Osteoarthritis of Knee
• Intervention / Treatment: Device: Extracorporeal Shock Waves; Other: Physical activities; Device: Sham Extracorporeal Shock Waves

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 04116-030
    • Recruiting
    • Centro de Pesquisa Clínica do Instituto de Medicina Física e Reabilitação do HCFMUSP
    • Contact: Fabíola Cavalieri, MD; Phone Number: 55-11-99212-3999; Email: fabiola.cavalieri@hc.fm.usp.br
    • Contact: Artur C Santos; Phone Number: 55-11-5180-7897; Email: artur.santos@hc.fm.usp.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Extracorporeal Shock Waves; Other: Physical activities; Patients receive instructions for physical activities for strengthening of femoral quadriceps and stretching of hamstring muscles.
Sham Comparator: 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.	Other: Physical activities; Patients receive instructions for physical activities for strengthening of femoral quadriceps and stretching of hamstring muscles.; Device: Sham Extracorporeal Shock Waves

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Principal Investigator: Linamara R Battistella, PhD, MD, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Anticipated): October 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: June 29, 2016
• First Submitted That Met QC Criteria: September 13, 2016
• First Posted (Estimate): September 19, 2016

Study Record Updates

• Last Update Posted (Estimate): September 19, 2016
• Last Update Submitted That Met QC Criteria: September 13, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 54013616.1.0000.0068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED