Extracorporeal Focused Shock Wave Therapy for Primary Knee Osteoarthritis

Unilateral Primary Osteoarthritis of Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02904785
• Other study ID #: 54013616.1.0000.0068
• Status: Recruiting
• Phase: Phase 2
• First received: June 29, 2016
• Last updated: September 13, 2016
• Start date: May 2016
• Est. completion date: December 2016

Study information

• Verified date: September 2016
• Source: University of Sao Paulo General Hospital
• Contact: Gilson T Shinzato, MD
• Phone: 55-11-99688-0698
• Email: g.shinzato[@]hc.fm.usp.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Unilateral Primary Osteoarthritis of Knee

Intervention

Device:
• Extracorporeal Shock Waves

• Sham Extracorporeal Shock Waves

Other:
• Physical activities
Patients receive instructions for physical activities for strengthening of femoral quadriceps and stretching of hamstring muscles.

Locations

Country	Name	City	State
Brazil	Centro de Pesquisa Clínica do Instituto de Medicina Física e Reabilitação do HCFMUSP	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Knee Pain after three months	Mean change in VAS score three months after the end of the treatment compared to baseline.	Three months	No
Secondary	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	No
Secondary	Lequesne Knee Function after three months	Mean change in Lequesne three months after the end of the treatment compared to baseline.	Three months	No
Secondary	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	No
Secondary	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	No
Secondary	WOMAC Knee Function after three months	Mean change in WOMAC score three months after the end of the treatment compared to baseline.	Three months	No
Secondary	TUG Knee Function after three months	Mean change in TUG score three months after the end of the treatment compared to baseline.	Three months	No