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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Istituto Nazionale di Ricovero e Cura per Anziani
Sponsor:
Collaborator:
Regione Marche
Information provided by (Responsible Party):
Istituto Nazionale di Ricovero e Cura per Anziani
ClinicalTrials.gov Identifier:
NCT01709058
First received: October 16, 2012
Last updated: October 17, 2012
Last verified: October 2012

October 16, 2012
October 17, 2012
August 2012
December 2014   (final data collection date for primary outcome measure)
Oswestry Disability Index(ODI) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

The Oswestry Disability Index (ODI) is used to investigate the functional impairment in activities of daily living related to low back pain. The ODI is one of the main measuring instruments necessary for the evaluation of disability from pain and is considered the gold standard for evaluation of disability in low back pain. It consists of 10 questions with multiple answers in which the patient chooses the answer that comes closest to its current state or to that of the last 2 weeks.

Response to treatment is considered as a binary classification: "success" if the Oswestry Disability Index is between 0 and 20% (minimal disability) and "failure" in the other cases.

Same as current
Complete list of historical versions of study NCT01709058 on ClinicalTrials.gov Archive Site
  • Oswestry Disability Index (ODI) [ Time Frame: 3 months follow-up ] [ Designated as safety issue: No ]

    The Oswestry Disability Index (ODI) is used to investigate the functional impairment in activities of daily living related to low back pain. The ODI is one of the main measuring instruments necessary for the evaluation of disability from pain and is considered the gold standard for evaluation of disability in low back pain. It consists of 10 questions with multiple answers in which the patient chooses the answer that comes closest to its current state or to that of the last 2 weeks.

    Response to treatment is considered as a binary classification: "success" if the Oswestry Disability Index is between 0 and 20% (minimal disability) and "failure" in the other cases.

  • Comprehensive geriatric assessment by INTERRAI-MDS-HC/VAOR-ADI instrument [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    identification information, personal data at admission, assessment date, cognitive function, communication and vision, mood and behaviour, physical function, incontinence, diagnosis of the disease, health conditions, oral and nutrition status, skin conditions, medications, treatment and procedures, advanced directives, discharge potential, discharge, assessment information, anamnestic-clinical data, standardised clinical assessment, physical performance tests
  • intake of paracetamol [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    The use of paracetamol is allowed during the study period for the treatment of low back pain, at a dose of no more than 4 grams a day
  • oxidative stress [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    The evaluation of oxidative stress by the d-ROMs test and total antioxidant capacity by the anti-ROMs test will be performed.
Same as current
Not Provided
Not Provided
 
Study on the Effects of Oxygen-ozone Therapy on Back Pain in Subjects Aged 65 or Older
Prospective, Randomized, Single Blind Trial on the Effects of Paravertebral Intramuscular Oxygen-ozone Therapy on Back Pain in Subjects Aged 65 or Older

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Back Pain
  • 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 Name: oxygen-ozone treatment
  • 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.
  • Experimental: Intramuscular/paravertebral injections of Oxygen-Ozone
    This group will be treated with "Intramuscular/paravertebral injections of Oxygen-Ozone" twice a week for six weeks
    Intervention: Drug: Intramuscular/paravertebral injections of Oxygen-Ozone
  • 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.
    Intervention: Other: Simulated intramuscular/paravertebral injections
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
130
August 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
65 Years and older
No
Contact: Oriano Mercante, MD 39 071 8003276 O.MERCANTE@inrca.it
Italy
 
NCT01709058
INRCA-02-2011, 2011-003185-33
No
Istituto Nazionale di Ricovero e Cura per Anziani
Istituto Nazionale di Ricovero e Cura per Anziani
Regione Marche
Not Provided
Istituto Nazionale di Ricovero e Cura per Anziani
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP