Prospective, controlled, randomized, blind study to evaluate the effects of intramuscular-paravertebral injections of an oxygen-ozone (O2-O3) mixture in patients with lumbar pain aged 65 or older

• Conditions: subjects aged 65 or older with lumbar pain and discopathy for at least 6 weeks; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]; MedDRA version: 14.1Level: SOCClassification code 10028395Term: Musculoskeletal and connective tissue disordersSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

• Registration Number: EUCTR2011-003185-33-IT
• Lead Sponsor: ISTITUTO NAZIONALE DI RICOVERO E CURA PER ANZIANI IRCCS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-05
• Last Update Posted: 25 September 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. subjects aged 65 or older 2. lumbar pain and discopathy for at least 6 weeks 3.Patients with diagnostic imaging performed by no longer than two years to exclude the presence of diseases or morphological conditions listed in the exclusion criteria 4. Oswestry Disability Index between 30% and 80% 5. Patients free from steroidal and nonsteroidal antinflammatory drugs from at least 10 days
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 130

Exclusion Criteria

1. clinical signs of radiculopathy 2. cauda equina syndrome 3. progressive neurologic deficit 4. lumbar stenosis 5. spondylolisthesis 6. lesions requiring immediately surgery 7. diabetic neuropathy 8. body mass index >30 9. lumbar scoliosis >20° 10. favism 11. Known or suspected hypersensitivity to paracetamol or controindications of its use

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effects of intramuscolar-paravertebral injection of an oxygen-ozone mixture in the treatment of lumbar pain with discopathy;Secondary Objective: 1.comprehensive geriatric assessment 2.Paracetamol assumption 3. Determination of markers of oxidative stress and plasmatic trace elements (Zn, Cu, Fe, Se);Timepoint(s) of evaluation of this end point: Visit 1: baseline; Visit 2: 2 weeks of treatment; Visit 3: 4 weeks of treatment; Visit 4: 6 weeks of treatment; Visit 5: 2 weeks of follow-up; Visit 6: 3 months of follow-up; Visit 7: 6 months of follow-up;Primary end point(s): Changes in Disability Index (ODI) obtained after administration dell'Oswestry Disability Questionnaire. Response to treatment is a binary classification: ''success'' if the Oswestry Disability Index at follow-up is between 0 and 20% and ''failure'' in the other cases.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Comprehensive geriatric assessment by INTERRAI-HC/VAOR-ADI instrument.;Timepoint(s) of evaluation of this end point: Visit 1: baseline; visit 6: 3 months of follow-up; visit 7: 6 months of follow-up