Extracorporeal Focused Shock Wave Therapy for Primary Knee Osteoarthritis

NCT02904785 | Unknown Phase 2 DMC

• 1 other identifier: 54013616.1.0000.0068
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Unilateral Primary Osteoarthritis of Knee

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Knee pain progression

  One week after each of four weekly ESWT applications

• Knee Pain after three months

  Three months

• Lequesne Knee Function progression

  One week after each of four weekly ESWT applications

• Lequesne Knee Function after three months

  Three months

• WOMAC Knee Function progression

  One week after each of four weekly ESWT applications

Study Arms (2)

Extracorporeal Shock Waves

EXPERIMENTAL

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

Sham Extracorporeal Shock Waves

SHAM COMPARATOR

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.

Device: Sham Extracorporeal Shock Waves; Other: Physical activities

Interventions

Extracorporeal Shock Waves DEVICE

Extracorporeal Shock Waves

Sham Extracorporeal Shock Waves DEVICE

Sham Extracorporeal Shock Waves

Physical activities OTHER

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

Extracorporeal Shock Waves; Sham Extracorporeal Shock Waves

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical and radiologic diagnosis of primary knee osteoarthritis (Kellgren \& Lawrence I, II or III);
• Capability to understand the Informed Consent Form;
• Absence of skin injures, infections or tumor in the target knee;
• Availability to comply with the visits.

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

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

São Paulo, São Paulo, 04116-030, Brazil

RECRUITING

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Linamara R Battistella, PhD, MD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gilson T Shinzato, MD

CONTACT

55-11-99688-0698; g.shinzato@hc.fm.usp.br

Fabíola Cavalieri, MD

CONTACT

55-11-99212-3999; fabiola.cavalieri@hc.fm.usp.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: September 19, 2016
• Study Start: May 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 19, 2016

Record last verified: 2016-09

Locations

BR (1)