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

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 - O2-O3 Therapy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-003185-33-IT

Enrollment

130

Registered

2012-03-05

Start date

2011-10-13

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

subjects aged 65 or older with lumbar pain and discopathy for at least 6 weeks MedDRA version: 14.1 Level: SOC Classification code 10028395 Term: Musculoskeletal and connective tissue disorders System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Trade Name: OSSIGENO*COMPR 200BAR 14L AC V Pharmaceutical Form: Medicinal gas, compressed INN or Proposed INN: NA CAS Number: 7782-44-7 Current Sponsor code: NA Other descriptive name: Dioxygen Concen

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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);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.;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	—

Measure

Time frame

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);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.;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

—

Secondary

Measure	Time frame
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	—

Countries

Italy

Contacts

Public ContactU.O. Riabilitazione Clinica

Istituto Nazionale di Ricovero e Cura per Anziani

o.mercante@inrca.it0718003276

Outcome results

None listed

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