Status:
COMPLETED
Efficacy of Radial Shockwave Therapy for Treatment of Pain in Knee Osteoarthritis
Lead Sponsor:
Marta Imamura
Collaborating Sponsors:
University of Sao Paulo
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief Summary
The objective of this study is to compare the results of 2000 impulses of radius shockwaves per week with 2000 placebo shockwaves on the treatment of pain and functional incapacity of patients with se...
Detailed Description
* Prospective, placebo controlled randomized and double-blind study. * Treatment Method: Radial extracorporeal shockwaves will be applied using the Swiss Dolorclast (EMS Electro Medical Systems, Swit...
Eligibility Criteria
Inclusion
- Clinical and radiological diagnosis of primary knee diagnosis.
- Pain intensity: Visual Analog Scale (VAS) ≥ 6;
- One of more failures with conventional treatment (drugs, Non-Steroidal Anti-inflammatory Drugs - NSAD, physiotherapy, stretching, acupuncture, orthosis and others);
- Age over 60 years;
- No use of corticosteroids in the prior 48 hours;
- No major osteoarthritis events in other joints of lower limbs (waist and ankle) and lower back;
- No clinical evidence of related neuropathy, including radiculopathy and peripheral neuropathy;
- Absence of systemic inflammatory disease (Rheumatoid arthritis, Reiter, ankylosing spondylitis, generalized polyarthritis, cancer);
- Absence of infection or cancer at the application site;
- Absence of related endocrine and metabolic diseases;
- Absence of fibromyalgia, diagnosed after the American College of Rheumatology, 1999;
- Absence of severe blood dyscrasias;
- Absence of severe psychiatric disturbances that requires psychiatric assessment;
- Availability to comply with the clinic visits and follow up evaluations along the treatment
Exclusion
- Patients who withdraw the informed consent form at any time
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT02197962
Start Date
May 1 2010
End Date
December 1 2015
Last Update
October 5 2016
Active Locations (2)
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1
Instituto de Ortopedia e Traumatologia HCFMUSP
São Paulo, São Paulo, Brazil, 05403-010
2
Instituto de Medicina Fisica e Reabilitacao HCFMUSP
São Paulo, São Paulo, Brazil, 05716-150