Condition category
Musculoskeletal Diseases
Date applied
23/10/2010
Date assigned
08/11/2010
Last edited
08/11/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Carlos César Lopes de Jesus

ORCID ID

Contact details

Rua Pedro de Toledo
598
São Paulo
04039-001
Brazil
+55 (0)11 55752970 / 50850248
caceloje@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NCT29102010

Study information

Scientific title

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

Acronym

INOPKA

Study hypothesis

Ozone is more affective than placebo in the treatment of knee arthritis.

Ethics approval

The Ethics Committee of Sao Paulo Medical School, Federal University of Sao Paolo (Escola Paulista de Medicina, Universidade Federal de São Paulo [EPM-UNIFESP]) approved on the 8th of October 2010

Study design

Randomised double blind placebo controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet.

Condition

Knee arthritis

Intervention

Patients will be randomised to receive either
1. Intraarticular ozone, 30μl/ml once a week over 8 weeks
2. Intraarticular ozone, once a week over 8 weeks

The follow-up will last for 2 months after the last session of treatment.

Intervention type

Drug

Phase

Phase III

Drug names

Ozone

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 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.

Overall trial start date

29/10/2010

Overall trial end date

31/10/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

108 patients

Participant 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

Recruitment start date

29/10/2010

Recruitment end date

31/10/2012

Locations

Countries of recruitment

Brazil

Trial participating centre

Rua Pedro de Toledo, 598
São Paulo
04039-001
Brazil

Sponsor information

Organisation

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

Sponsor details

c/o Carlos César Lopes de Jesus
Rua Pedro de Toledo
598
São Paulo
04039-001
Brazil
+55 (0)11 55752970 / 50850248
caceloje@gmail.com

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Sao Paolo Medical School (Escola Paulista de Medicina) (Brazil) - Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes