Study on the Effects of Oxygen-ozone Therapy on Back Pain in Subjects Aged 65 or Older (O2-O3)

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status and phase: Unknown; Phase 4

Conditions: Back Pain

Treatments: Drug: Intramuscular/paravertebral injections of Oxygen-Ozone; Other: Simulated intramuscular/paravertebral injections

Study type: Interventional

Funder types: Other

Identifiers

NCT01709058

2011-003185-33 (EudraCT Number)

INRCA-02-2011

Details and patient eligibility

About

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.

Full description

Back pain is a leading cause of disability, including impairment in activities of daily living. In particular, the persistence of low back pain is more frequent in the elderly, associated with functional limitations and difficulties to perform tasks in everyday life. In addition to pharmacological treatments, various non-surgical interventional procedures are used for the treatment of low back pain. Some recent studies have evaluated the interventional oxygen-ozone (O2-O3) therapy in the treatment of back pain. However, these results are based on the technique of intradiscal infiltration / intraforaminal of O2-O3, while the intramuscular injection technique / paravertebral is the most widely used in clinical practice in Italy. In general, minimally invasive treatments such as percutaneous infiltration, are well tolerated and have been shown to produce clinical results, although the number of controlled studies is still scarce and the studies are often not comparable. Taking into account the above considerations, it seems appropriate to try to broaden the knowledge on the use of O2-O3 in the treatment of low back pain, using the technique of intramuscular injection / paravertebral, with particular reference to the elderly population.

The primary objective of this trial is therefore to evaluate the effects of O2-O3 therapy in the treatment of back pain associated with lumbar disc disease using the technique of intramuscular injection/paravertebral. These effects will be evaluated after a 6 weeks treatment period and after a 3 months follow-up period.

The project will include 130 subjects aged 65 or older who will be randomly enrolled in two different types of intervention:

• Oxygen-ozone therapy
• Simulated treatment

fully described below in the section: Interventions

In addition to clinical evaluations, the trial will contribute to the study of biological bases of the O2-O3 therapy as the levels of trace elements, oxidative status and antioxidant capacity in plasma will be evaluated.

Enrollment: 130 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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130 participants in 2 patient groups

Intramuscular/paravertebral injections of Oxygen-Ozone

Experimental group

Description:

This group will be treated with "Intramuscular/paravertebral injections of Oxygen-Ozone" twice a week for six weeks

Treatment:

Drug: Intramuscular/paravertebral injections of Oxygen-Ozone

Simulated treatment

Other group

Description:

The "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.

Treatment:

Other: Simulated intramuscular/paravertebral injections