Back PainPhase 4O2-O3NCT01709058
Study on the Effects of Oxygen-ozone Therapy on Back Pain in Subjects Aged 65 or Older
A Phase 4 study testing Intramuscular/paravertebral injections of Oxygen-Ozone and Simulated intramuscular/paravertebral injections in people with Back Pain, run by Istituto Nazionale di Ricovero e Cura per Anziani at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Back Pain
- What is being tested?
- Intramuscular/paravertebral injections of Oxygen-Ozone and Simulated intramuscular/paravertebral injections
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2012to Aug 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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%
Who cannot join
- heart failure
- favism
- clinically hyperthyroidism
- cancer and concomitant chemo-or radio-therapy
- epilepsy
- asthma
Show all 14Show fewer
- life expectancy of 6 months or less
- psychotic drugs
- clinical signs of radiculopathy
- polyradiculopathy
- progressive neurological deficit
- lumbar stenosis
- spondylolisthesis
- diabetic neuropathy
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
INRCA Hospital, via della Montagnola, 81
Ancona, I-60131
Oriano Mercante, MD, O.MERCANTE@inrca.it
About this study
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
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.
Read the 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.
- Conditions
- Back Pain
- Being tested
- Intramuscular/paravertebral injections of Oxygen-Ozone, Simulated intramuscular/paravertebral injections
- Keywords
- Back Pain, Therapeutics, Aged, Injections, Intramuscular, Oxygen, Ozone, Geriatric Assessment, Trace Elements, Oxidative stress
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intramuscular/paravertebral injections of Oxygen-OzoneDrug
Also called oxygen-ozone treatment
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 intramuscular/paravertebral injectionsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intramuscular/paravertebral injections of Oxygen-Ozone | Experimental | This group will be treated with "Intramuscular/paravertebral injections of Oxygen-Ozone" twice a week for six weeks Receives: Drug: Intramuscular/paravertebral injections of Oxygen-Ozone |
| Simulated treatment | Other | 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. Receives: Other: Simulated intramuscular/paravertebral injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (4)
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.
Measured: 3 months follow-up
Comprehensive geriatric assessment by INTERRAI-MDS-HC/VAOR-ADI instrument
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
Measured: 6 weeks
intake of paracetamol
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
Measured: 6 weeks
oxidative stress
The evaluation of oxidative stress by the d-ROMs test and total antioxidant capacity by the anti-ROMs test will be performed.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2014 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per Anziani
- Sponsor type
- University, hospital or other
- Collaborators
- Regione Marche
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01709058
- Sponsor's protocol ID
- INRCA-02-2011
- Other IDs
- 2011-003185-33
- Acronym
- O2-O3
- Status last verified
- Oct 2012
- First submitted
- 16 Oct 2012
- Last updated
- 18 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01709058
- Acronym / sponsor ID
- O2-O3 / INRCA-02-2011
- Conditions
- Back Pain
- Keywords
- Back Pain, Therapeutics, Aged, Injections, Intramuscular, Oxygen, Ozone, Geriatric Assessment, Trace Elements
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per AnzianiUniversity, hospital or other
- Collaborators
- Regione Marche
- Study start
- Aug 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 17 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intramuscular/paravertebral injections of Oxygen-Ozone | Experimental | Drug: Intramuscular/paravertebral injections of Oxygen-OzoneThis group will be treated with "Intramuscular/paravertebral injections of Oxygen-Ozone" twice a week for six weeks |
| Simulated treatment | Other | Other: Simulated intramuscular/paravertebral injectionsThe "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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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%
Key exclusion criteria (14 listed)
- heart failure
- favism
- clinically hyperthyroidism
- cancer and concomitant chemo-or radio-therapy
- epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intramuscular/paravertebral injections of Oxygen-OzoneAlso: oxygen-ozone treatmentMedical 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 | Drug | Intramuscular/paravertebral injections of Oxygen-Ozone |
| Simulated intramuscular/paravertebral injectionsThe 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. | Other | Simulated treatment |
Primary outcome
Oswestry Disability Index(ODI)
Time frame: 6 weeks
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.
4 secondary outcomes
Oswestry Disability Index (ODI)
Time frame: 3 months follow-up
Comprehensive geriatric assessment by INTERRAI-MDS-HC/VAOR-ADI instrument
Time frame: 6 weeks
intake of paracetamol
Time frame: 6 weeks
oxidative stress
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intramuscular/paravertebral injections of Oxygen-Ozone and Simulated intramuscular/paravertebral injections in people with Back Pain, run by Istituto Nazionale di Ricovero e Cura per Anziani at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oriano Mercante, MD (39 071 8003276, O.MERCANTE@inrca.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index(ODI) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2012.