Low Back PainNCT03038529
Variable Approaches of Intradiscal O3-O2 Injection
A study testing Classic postrolateral extraarticular percutaneous approach for O3 injection and Postrolateral transforaminal approach (Yess approach ) for O3 injection in people with Low Back Pain, run by Assiut University at 1 site in Egypt.
Trial summary
Cost Intradiscal injection of ozone-oxygen mixture (O3-O2) which offers a rapid onset amelioration of symptoms, with a sustained duration pain relief in low back pain. Does change of injection approach make a difference? Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Classic postrolateral extraarticular percutaneous approach for O3 injection and Postrolateral transforaminal approach (Yess approach ) for O3 injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2015to 30 Nov 2016
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- radicular leg pain
- low back pain
- non-responsive to conservative treatment
Who cannot join
- patient refusal
- infection at injection site
- coagulopathy
- uncontrolled or degenerative spine disease
- pregnancy
- multilevel disk involvement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Variable Approaches of Intradiscal O3-O2 Injection for Management of Low Back Pain: Could it Make a Difference? a Prospective Double Blind Randomized Clinical Trial.
Cost Intradiscal injection of ozone-oxygen mixture (O3-O2) which offers a rapid onset amelioration of symptoms, with a sustained duration pain relief in low back pain.
Does change of injection approach make a difference?
Read the detailed description
Low back pain (LBP) mostly is induced by disc herniation (DH), or degeneration and has a burden upon social and economic aspects of life. Medical and or surgical interventions have been used to resolve this problem, but one of the newly introduced is the minimally invasive low cost Intradiscal injection of ozone-oxygen mixture (O3-O2) which offers a rapid onset amelioration of symptoms, with a sustained duration pain relief.
A lot of injection approaches are available, but which offers the best results, is the question.
- Conditions
- Low Back Pain
- Being tested
- Classic postrolateral extraarticular percutaneous approach for O3 injection, Postrolateral transforaminal approach (Yess approach ) for O3 injection
- Keywords
- low back pain , Ozone
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classic postrolateral extraarticular percutaneous approach for O3 injectionProcedure or surgery
Receive 10 ml of ozone oxygen mixture 30 ug O3/ml O2 through the classic postrolateral extraarticular percutaneous approach
Postrolateral transforaminal approach (Yess approach ) for O3 injectionProcedure or surgery
Group B receive 10 ml of ozone oxygen mixture 30 ug O3/ml O2 through postrolateral transforaminal approach (Yess approach ).
| Study group | Role | What they receive |
|---|---|---|
| A: Classic approach | Other | Intradiscal O3 injection through classic postrolateral extraarticular percutaneous approach.
The participants will receive 10 ml of ozone oxygen mixture 30 ug O3/ml O2. The ozone-oxygen mixture was produced in real-time by a medical ozone generator (Ozonline E 80, Medica srl, Bologna Italy). Receives: Procedure: Classic postrolateral extraarticular percutaneous approach for O3 injection |
| B: Transforaminal approach (Yess approach ) | Active comparator | Participants will receive 10 ml of ozone oxygen mixture 30 ug O3/ml O2 through postrolateral transforaminal approach (Yess approach).
The ozone-oxygen mixture was produced in real-time by a medical ozone generator (Ozonline E 80, Medica srl, Bologna Italy). Receives: Procedure: Postrolateral transforaminal approach (Yess approach ) for O3 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of pain alleviation (visual analog scale)
assessing visual analog scale (VAS)
Measured: one year
Secondary outcomes (1)
Analgesia reduction (percent)
the percent of analgesia reduction
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start1 Jan 2015
- Primary completion30 Oct 2016
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emad Zarief , MD, Assiut University
- Investigators
- Abdelraheem Alawaamy, MD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03038529
- Sponsor's protocol ID
- IRB00009903
- Status last verified
- Dec 2017
- First submitted
- 28 Jan 2017
- Last updated
- 8 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variable Approaches of Intradiscal O3-O2 Injection for Management of Low Back Pain: Could it Make a Difference? a Prospective Double Blind Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03038529
- Acronym / sponsor ID
- IRB00009903
- Conditions
- Low Back Pain
- Keywords
- low back pain , Ozone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 Oct 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 31 Jan 2017 (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.
Cost Intradiscal injection of ozone-oxygen mixture (O3-O2) which offers a rapid onset amelioration of symptoms, with a sustained duration pain relief in low back pain.
Does change of injection approach make a difference?
Detailed description
Low back pain (LBP) mostly is induced by disc herniation (DH), or degeneration and has a burden upon social and economic aspects of life. Medical and or surgical interventions have been used to resolve this problem, but one of the newly introduced is the minimally invasive low cost Intradiscal injection of ozone-oxygen mixture (O3-O2) which offers a rapid onset amelioration of symptoms, with a sustained duration pain relief.
A lot of injection approaches are available, but which offers the best results, is the question.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Classic approach | Other | Procedure: Classic postrolateral extraarticular percutaneous approach for O3 injectionIntradiscal O3 injection through classic postrolateral extraarticular percutaneous approach. The participants will receive 10 ml of ozone oxygen mixture 30 ug O3/ml O2. The ozone-oxygen mixture was produced in real-time by a medical ozone generator (Ozonline E 80, Medica srl, Bologna Italy). |
| B: Transforaminal approach (Yess approach ) | Active comparator | Procedure: Postrolateral transforaminal approach (Yess approach ) for O3 injectionParticipants will receive 10 ml of ozone oxygen mixture 30 ug O3/ml O2 through postrolateral transforaminal approach (Yess approach). The ozone-oxygen mixture was produced in real-time by a medical ozone generator (Ozonline E 80, Medica srl, Bologna Italy). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- radicular leg pain
- low back pain
- non-responsive to conservative treatment
Key exclusion criteria (6 listed)
- patient refusal
- infection at injection site
- coagulopathy
- uncontrolled or degenerative spine disease
- pregnancy
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 |
|---|---|---|
| Classic postrolateral extraarticular percutaneous approach for O3 injectionReceive 10 ml of ozone oxygen mixture 30 ug O3/ml O2 through the classic postrolateral extraarticular percutaneous approach | Procedure or surgery | A: Classic approach |
| Postrolateral transforaminal approach (Yess approach ) for O3 injectionGroup B receive 10 ml of ozone oxygen mixture 30 ug O3/ml O2 through postrolateral transforaminal approach (Yess approach ). | Procedure or surgery | B: Transforaminal approach (Yess approach ) |
Primary outcome
Quality of pain alleviation (visual analog scale)
Time frame: one year
assessing visual analog scale (VAS)
1 secondary outcome
Analgesia reduction (percent)
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2017.
- Individual participant dataSharing planned: Undecided
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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.
Abdelraheem Alawaamy, MD study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Classic postrolateral extraarticular percutaneous approach for O3 injection and Postrolateral transforaminal approach (Yess approach ) for O3 injection in people with Low Back Pain, run by Assiut University at 1 site in Egypt.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 8 Dec 2017. 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 Egypt. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of pain alleviation (visual analog scale) (time frame: one year). 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 8 Dec 2017.