Clinical trial NCT01709058: Study on the Effects of Oxygen-ozone Therapy on Back Pain in Subjects Aged 65 or Older
Official title: Prospective, Randomized, Single Blind Trial on the Effects of Paravertebral Intramuscular Oxygen-ozone Therapy on Back Pain in Subjects Aged 65 or Older
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Back Pain
Keywords: Back Pain
Therapeutics
Aged
Injections, Intramuscular
Oxygen
Ozone
Geriatric Assessment
Trace Elements
Oxidative stress
Lead sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
Sponsor class: OTHER
Collaborators: name: Regione Marche
First posted: 2012-10-17
Enrollment: 130
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Oswestry Disability Index(ODI)
timeFrame: 6 weeks
Secondary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: 3 months follow-up
measure: Comprehensive geriatric assessment by INTERRAI-MDS-HC/VAOR-ADI instrument
timeFrame: 6 weeks
measure: intake of paracetamol
timeFrame: 6 weeks
measure: oxidative stress
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: INRCA Hospital, via della Montagnola, 81
Study officials:
References: