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

NCT ID: NCT01709058

Last Updated: 2012-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Back Pain

Keywords

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Back Pain Therapeutics Aged Injections, Intramuscular Oxygen Ozone Geriatric Assessment Trace Elements Oxidative stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Intramuscular/paravertebral injections of Oxygen-Ozone

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

Group Type EXPERIMENTAL

Intramuscular/paravertebral injections of Oxygen-Ozone

Intervention Type DRUG

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

Simulated treatment

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.

Group Type OTHER

Simulated intramuscular/paravertebral injections

Intervention Type OTHER

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.

Interventions

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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

Intervention Type DRUG

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.

Intervention Type OTHER

Other Intervention Names

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oxygen-ozone treatment

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regione Marche

OTHER

Sponsor Role collaborator

Istituto Nazionale di Ricovero e Cura per Anziani

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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INRCA Hospital, via della Montagnola, 81

Ancona, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Oriano Mercante, MD

Role: CONTACT

Phone: 39 071 8003276

Email: [email protected]

Facility Contacts

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Oriano Mercante, MD

Role: primary

Other Identifiers

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2011-003185-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

INRCA-02-2011

Identifier Type: -

Identifier Source: org_study_id