Pain, ChronicNCT03023969
Implication of Two Doses of O2-O3 Upon the Pain Alleviation in Patients With Low Back Pain
A study testing ozone oxygen mixture in people with Pain, Chronic, run by Assiut University at 1 site in Egypt.
Trial summary
Low back pain is very common problem, variable modalities have been introduced to control such problem. One of the emerging modalities is the ozone - oxygen (O2-O3 ) mixture that could reduce the herniation disk size and inflammation. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pain, Chronic
- What is being tested?
- ozone oxygen mixture
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2015to Dec 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
- All patients Suffered radicular leg pain and some reported additional back pain.
- All patients are non-responsive to conservative treatment modalities with VAS more than 7.
Who cannot join
- presence of bleeding disorder
- local infection
- uncontrolled or degenerative spine disease
- pregnancy
- multilevel disk involvement
- patient refusal.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implication of Two Different Doses of Intradiscal O2-O3 Injection Upon the Pain Alleviation in Patients With Low Back Pain: A Randomized, Single-blind Study
Low back pain is very common problem, variable modalities have been introduced to control such problem. One of the emerging modalities is the ozone - oxygen (O2-O3 ) mixture that could reduce the herniation disk size and inflammation.
Read the detailed description
Intervertebral disc herniation is the most common problem which induces low back pain LBP. The number of patients seek surgical and or alternative therapy increases. The rate of re-operation is between 7-9% at 2 years and increases up to 10-25% at ten years postoperative.
Epidural injections with local anesthetics and steroids are one of the most commonly used interventions in managing chronic low back pain and lower extremity pain of various causes. However, despite their extensive use, debate continues on this medications effectiveness due to the lack of well-designed, randomized, controlled studies to determine the effectiveness of epidural injections in general, and caudal epidural injections in particular.
Ozone in mixture with oxygen has been justified in multiple studies have been done, this study aims to evaluate variable doses of this mix upon patient satisfaction, pain alleviation over 12 month follow up period .
- Conditions
- Pain, Chronic
- Being tested
- ozone oxygen mixture
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ozone oxygen mixtureDrug
receive 10 ml of ozone oxygen mixture under variable dosing
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | percutaneous ozone intradiscal injection group A receive 10 ml of ozone oxygen mixture 40 ug O3/ ml O2 Receives: Drug: ozone oxygen mixture |
| group B | Active comparator | percutaneous ozone intradiscal injection group receive 10 ml of ozone oxygen mixture 30 ug O3/ ml O2. Receives: Drug: ozone oxygen mixture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain alleviation by visual analogue scale (VAS)
assessing pain alleviation by visual analogue scale (VAS)
Measured: 12 months
Secondary outcomes (2)
Reduction of disk herniation by MRI
evaluation of disk herniation by MRI 6 month after injection, in comparison to the pre-injection MRI
Measured: 6 months
Pain alleviation using Oswestry Low Back Pain Questionnaire
using Oswestry Low Back Pain Questionnaire
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study startAug 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, ChronicStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emad Zarief , MD, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03023969
- Sponsor's protocol ID
- IRB00009908
- Status last verified
- Feb 2017
- First submitted
- 12 Jan 2017
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Elawamy A, Kamel EZ, Hassanien M, Wahba OM, Amin SE. Implication of Two Different Doses of Intradiscal Ozone-Oxygen Injection upon the Pain Alleviation in Patients with Low Back Pain: A Randomized, Single-Blind Study. Pain Physician. 2018 Jan;21(1):E25-E31.
PubMed 29357333
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implication of Two Different Doses of Intradiscal O2-O3 Injection Upon the Pain Alleviation in Patients With Low Back Pain: A Randomized, Single-blind Study
- ClinicalTrials.gov ID
- NCT03023969
- Acronym / sponsor ID
- IRB00009908
- Conditions
- Pain, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 18 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.
Low back pain is very common problem, variable modalities have been introduced to control such problem. One of the emerging modalities is the ozone - oxygen (O2-O3 ) mixture that could reduce the herniation disk size and inflammation.
Detailed description
Intervertebral disc herniation is the most common problem which induces low back pain LBP. The number of patients seek surgical and or alternative therapy increases. The rate of re-operation is between 7-9% at 2 years and increases up to 10-25% at ten years postoperative.
Epidural injections with local anesthetics and steroids are one of the most commonly used interventions in managing chronic low back pain and lower extremity pain of various causes. However, despite their extensive use, debate continues on this medications effectiveness due to the lack of well-designed, randomized, controlled studies to determine the effectiveness of epidural injections in general, and caudal epidural injections in particular.
Ozone in mixture with oxygen has been justified in multiple studies have been done, this study aims to evaluate variable doses of this mix upon patient satisfaction, pain alleviation over 12 month follow up period .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Drug: ozone oxygen mixturepercutaneous ozone intradiscal injection group A receive 10 ml of ozone oxygen mixture 40 ug O3/ ml O2 |
| group B | Active comparator | Drug: ozone oxygen mixturepercutaneous ozone intradiscal injection group receive 10 ml of ozone oxygen mixture 30 ug O3/ ml O2. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- All patients Suffered radicular leg pain and some reported additional back pain.
- All patients are non-responsive to conservative treatment modalities with VAS more than 7.
Key exclusion criteria (6 listed)
- presence of bleeding disorder
- local infection
- uncontrolled or degenerative spine disease
- pregnancy
- multilevel disk involvement
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 |
|---|---|---|
| ozone oxygen mixturereceive 10 ml of ozone oxygen mixture under variable dosing | Drug | group A, group B |
Primary outcome
Pain alleviation by visual analogue scale (VAS)
Time frame: 12 months
assessing pain alleviation by visual analogue scale (VAS)
2 secondary outcomes
Reduction of disk herniation by MRI
Time frame: 6 months
Pain alleviation using Oswestry Low Back Pain Questionnaire
Time frame: 12 months
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 7 Feb 2017.
- Derived from this study: PubMed 29357333Elawamy A, Kamel EZ, Hassanien M, Wahba OM, Amin SE. Implication of Two Different Doses of Intradiscal Ozone-Oxygen Injection upon the Pain Alleviation in Patients with Low Back Pain: A Randomized, Single-Blind Study. Pain Physician. 2018 Jan;21(1):E25-E31.
- Individual participant dataSharing planned: Undecided
Related trials for Pain, Chronic
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ozone oxygen mixture in people with Pain, Chronic, 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 2 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 7 Feb 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?
Pain alleviation by visual analogue scale (VAS) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03023969, which also lists 1 linked publication.
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 7 Feb 2017.