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

Study Overview
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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.

Official Title
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Prospective, Randomized, Single Blind Trial on the Effects of Paravertebral Intramuscular Oxygen-ozone Therapy on Back Pain in Subjects Aged 65 or Older

Conditions
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Back Pain

Intervention / Treatment
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* Drug: Intramuscular/paravertebral injections of Oxygen-Ozone
* Other: Simulated intramuscular/paravertebral injections


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intramuscular/paravertebral injections of Oxygen-Ozone<br>This group will be treated with Intramuscular/paravertebral injections of Oxygen-Ozone twice a week for six weeks | Drug: Intramuscular/paravertebral injections of Oxygen-Ozone<br>* 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<br>* Other names: oxygen-ozone treatment;|
| Other: Simulated treatment<br>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. | Other: Simulated intramuscular/paravertebral injections<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 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. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Back Pain, Therapeutics, Aged, Injections, Intramuscular, Oxygen, Ozone, Geriatric Assessment, Trace Elements, Oxidative stress