Study on the Effects of Oxygen-ozone Therapy on Back Pain in Subjects Aged 65 or Older
O2-O3
Prospective, Randomized, Single Blind Trial on the Effects of Paravertebral Intramuscular Oxygen-ozone Therapy on Back Pain in Subjects Aged 65 or Older
2 other identifiers
interventional
130
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Aug 2012
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 16, 2012
CompletedFirst Posted
Study publicly available on registry
October 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedOctober 18, 2012
October 1, 2012
2.3 years
October 16, 2012
October 17, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Oswestry Disability Index(ODI)
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.
6 weeks
Secondary Outcomes (4)
Oswestry Disability Index (ODI)
3 months follow-up
Comprehensive geriatric assessment by INTERRAI-MDS-HC/VAOR-ADI instrument
6 weeks
intake of paracetamol
6 weeks
oxidative stress
6 weeks
Study Arms (2)
Intramuscular/paravertebral injections of Oxygen-Ozone
EXPERIMENTALThis group will be treated with "Intramuscular/paravertebral injections of Oxygen-Ozone" twice a week for six weeks
Simulated treatment
OTHERThe "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.
Interventions
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
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.
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Istituto Nazionale di Ricovero e Cura per Anzianilead
- Regione Marchecollaborator
Study Sites (1)
INRCA Hospital, via della Montagnola, 81
Ancona, I-60131, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2012
First Posted
October 17, 2012
Study Start
August 1, 2012
Primary Completion
December 1, 2014
Study Completion
August 1, 2015
Last Updated
October 18, 2012
Record last verified: 2012-10