Back Pain | Study on the Effects of Oxygen-ozone Therapy on Back Pain in Subjects Aged 65 or Older
Back Pain research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Intramuscular/paravertebral injections of Oxygen-OzoneMedical 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 injectionsThe 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.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Intramuscular/paravertebral injections of Oxygen-OzoneThis group will be treated with "Intramuscular/paravertebral injections of Oxygen-Ozone" twice a week for six weeks
Simulated treatmentThe "Simulated intramuscular/paravertebral injections" will mimic the Oxygen-Ozone injections in the area to be treated by pricking the skin with the needle without drilling. These simulated injections will be performed twice a week for six weeks.
Start Date: August 2012
Completed Date: August 2015
Phase: Phase 4
Primary Outcome: Oswestry Disability Index(ODI)
Secondary Outcome: Oswestry Disability Index (ODI)
Study sponsors, principal investigator, and references
Lead Sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
Collaborator: Regione Marche