Comparison between intraarticular ozone and a placebo in the treatment of knee arthritis

Phase 3

Completed

• Conditions: Knee osteoarthritis; Musculoskeletal Diseases; Gonarthrosis [arthrosis of knee]

• Registration Number: ISRCTN55861167
• Lead Sponsor: Sao Paolo Medical School (Escola Paulista de Medicina) (Brazil)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-08
• Last Update Posted: 6 February 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

Inclusion criteria as of 30/12/2016:
1. Patients from Outpatients Department of Geriatrics and Gerontology Discipline – Paulista School of Medicine – Federal University of Sao Paulo, Pro-Vida – Centro de Assistencia Integral a Saude, and Outpatients Department – Rheumatology Discipline – Medical College – Santo Amaro University
2. Aged between 60 years and 85 years
3. Clinically and radiologically confirmed knee osteoarthritis according to the American College of Rheumatology (ACR) criteria

Original inclusion criteria:
1. Patients from Outpatients Department of Geriatrics and Gerontology Discipline da Escola Paulista de Medicina - Universidade Federal de São Paulo
2. Aged more than 60 years or less than 85 years
3. Clinically and radiologically confirmed knee arthritis according to the American College of Rheumatology (ACR) criteria

Exclusion Criteria

Exclusion criteria as of 30/12/2016:
1. Patients from Outpatients Department of Geriatrics and Gerontology Discipline – Paulista School of Medicine – Federal University of Sao Paulo, Pro-Vida – Centro de Assistencia Integral a Saude, and Outpatients Department – Rheumatology Discipline – Medical College – Santo Amaro University,
2. Aged between 60 years and 85 years, and
3. Clinically and radiologically confirmed knee osteoarthritis according to the American College of Rheumatology (ACR) criteria.

Original exclusion criteria:
1. Patients aged less than 60 years or more than 75 years
2. Will not give their permission to be included in the study
3. Patients with mental and/or neurologic deficit
4. Diagnosis of secondary osteoarthrosis, patients with recent knee traumas or
5. Suspected associated knee lesion
6. Patients with coxofemoral articulation affections
7. In the acute phase of the disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome measures as of 30/12/2016:<br>Reduction of pain measured according to<br>1. Visual Analogue Scale (VAS)<br>2. Lequesne Algofunctional Index<br>3. Geriatric Pain Measure (GPM)<br><br>All outcomes will be measured at baseline, 4 and 8 weeks and 2 months.<br><br>Original primary outcome measures:<br>Efficacy of treatment measured according to <br>1. Lequesne Algofunctional Index<br>2. Time Up and Go Test<br>3. Activities of Daily Living (ADLs)<br>4. Medical Outcomes Study 36-Item Short Form <br>5. Health Survey (MOS SF36 Health Survey)<br>6. Visual Analogue Scale (VAS) <br>7. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Index)<br><br>All outcomes will be measured at baseline, 4 and 8 weeks and 2 months.

Secondary Outcome Measures

Name	Time	Method
Secondary outcome measures as of 30/12/2016:<br>Improvement of joint function and quality of life according to:<br>1. Time Up and Go Test <br>2. Medical Outcomes Study 36-Item Short Form<br>3. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Index)<br><br>All outcomes will be measured at baseline, 4 and 8 weeks and 2 months<br><br>Original secondary outcome measures:<br>Pain reduction according to <br>1. Lequesne Algofunctional Index <br>2. VAS<br>All outcomes will be measured at baseline, 4 and 8 weeks and 2 months.