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

INTERVENTION: 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 affected knee and application of the following questionnaires and tests: Visual Analogue Scale (VAS), Geriatric Pain Measure (GPM), Lequesne’s Index, Timed Up and Go Test (TUG Test), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Short‐Form Health Survey (SF‐36). Eligible patients are fully informed of the purpose of the study. All patients that fulfill the inclusion criteria signed the informed consent prior to enrolment in the trial. They are instructed to continue their medical treatment according to their physicians’ orientations. With the objective of avoiding selection bias, all included participants are sequentially assigned by the researchers to receive OZ or PBO according to a pre‐established computer‐generated global randomization list. This is carried out in such a manner as to guarantee each patient an equal chance of receiving the intervention. The randomization list is generated using software ETCETERA, version 2.46, and constituted 98 numbers with the corresponding treatments. Prior to the beginning of the randomization it has been stipulated that group A would be the ozone group and B, the placebo group. Ozone group (OZ): Participants receive one intra articular injection of ozone 20 µg/ml (10ml) per week for 8 consecutive weeks. Placebo group (PBO): Participants receive one intra articular injection of 10 ml of air per week for 8 consecutive weeks. Assessments are performed at baseline (visit 1), 4 weeks (visit 2), 8 weeks (visit 3), and 8 weeks after the end of the injections (visit 4). At the follow‐up visits, the same procedures as those described for visit 1 are performed. Original interventions section: Patients will be randomized to receive either intra articular ozone, 20µg/ml once a week for 8 consecutive weeks, CONDITION: Knee osteoarthritis ; Musculoskeletal Diseases ; Gonarthrosis [arthrosis of knee] PRIMARY OUTCOME: 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 OUTCOME: 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. 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