The Efficacy of Extracorporeal Focused Shock Wave Therapy for Patients With Primary Knee Osteoarthritis
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Unilateral Primary Osteoarthritis of Knee
- Sponsor
- University of Sao Paulo General Hospital
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Knee Pain after one month
- Last Updated
- 9 years ago
Overview
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.
Investigators
Linamara Rizzo Battistella, MD PhD
PhD
University of Sao Paulo General Hospital
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.
Outcomes
Primary Outcomes
Knee Pain after one month
Time Frame: One month
Mean change in Visual Analogue Scale (VAS) score one month after the end of the treatment compared to baseline.
Secondary Outcomes
- 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)
- TUG Knee Function progression(One week after each of four weekly ESWT applications)
- WOMAC Knee Function after three months(Three months)
- TUG Knee Function after three months(Three months)