Overview

Study on the Effects of Oxygen-ozone Therapy on Back Pain in Subjects Aged 65 or Older

Status:
Unknown status
Trial end date:
2015-08-01
Target enrollment:
0
Participant gender:
All
Summary
This study aims to evaluate the efficacy of the oxygen-ozone therapy in the treatment of back pain in subjects aged 65 or older. In particular, the intramuscular injection technique/paravertebral of oxygen-ozone mixture, a minimal invasive treatment with respect to intradiscal infiltration/intraforaminal technique, will be used.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Istituto Nazionale di Ricovero e Cura per Anziani
Collaborator:
Regione Marche
Criteria
Inclusion Criteria:

- patients aged 65 or older

- intervertebral disc degeneration

- back pain persistent for at least 6 weeks

- painkillers and anti-inflammatory drugs

- ODI score at baseline between 30 and 80%

Exclusion Criteria:

- heart failure

- favism

- clinically hyperthyroidism

- cancer and concomitant chemo-or radio-therapy

- epilepsy

- asthma

- life expectancy of 6 months or less

- psychotic drugs

- clinical signs of radiculopathy

- polyradiculopathy

- progressive neurological deficit

- lumbar stenosis

- spondylolisthesis

- diabetic neuropathy