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

Comparison between intraarticular ozone and a placebo in the treatment of knee arthritis: A double blind, randomised placebo controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN55861167
Enrollment
96
Registered
2010-11-08
Start date
2010-11-19
Completion date
Unknown
Last updated
2017-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee osteoarthritis Musculoskeletal Diseases Gonarthrosis [arthrosis of knee]

Interventions

Interventions section as of 11/01/2017: Study participants attend a baseline visit at which the following procedures are performed: medical history, physical examination, analysis of X-ray of the affe

Sponsors

Sao Paolo Medical School (Escola Paulista de Medicina) (Brazil)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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: 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

Design outcomes

Primary

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

Secondary

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

Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026