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

NCT01709058 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2012-10-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Intramuscular/paravertebral injections of Oxygen-Ozone

Medical Oxygen will be used as a part of the injected mixture (100% oxygen, 200 bar compressed gas in steel cylinder with valve 14 with an integrated reductive). For the generation of the Oxygen-Ozone mixture a certified equipment OZONOSAN alpha plus will be used according to the D.L. 46/97, EEC Directive 93/42, class 2A with a photometer. The mixture of O2-O3 is produced through a method called "silent discharge". Intramuscular/paravertebral injections to 3 cm from the spinal medial line will be performed introducing 5-20 mL of oxygen-ozone to each point, at a concentration of 10-20 micrograms/mL, for a total volume of 40 mL

OTHER

Simulated intramuscular/paravertebral injections

The simulated treatment administration will mimic the treatment in the area to be treated by pricking the skin with the needle without drilling. A light massage will be practice by hand and the application area will be covered with a bandage adhesive leaving the patient in the prone position for 10-15 minutes.

Sponsors & Collaborators

  • Regione Marche

    collaborator OTHER

  • Istituto Nazionale di Ricovero e Cura per Anziani

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-12-31
Completion
2015-08-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01709058 on ClinicalTrials.gov