Effect of DrugNCT04562493
Comparative Effect of Transforaminal Injection of Magnesium Sulphate Versus Ozone Therapy on Oxidative Stress Biomarkers in Lumbar Disc Related Radicular Pain
A study testing Transforaminal Epidural injection in people with Effect of Drug, run by Beni-Suef University at 1 site in Egypt.
Trial summary
Chronic lumbar radicular (CLR) pain is a term used to describe neuropathic pain symptoms in the distribution of a particular lumbar nerve root due to disc protrusion, spinal stenosis, facet hypertrophy, or fibrosis after previous surgery. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Effect of Drug
- What is being tested?
- Transforaminal Epidural injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Oct 2020to 5 Apr 2021
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed as having symptomatic lumbar disc prolapse based on the following:
- Clinical evidence of disc pulge in the form of disc related radicular pain of >3 months duration, not responding to conservative treatment and interfering with daily activities
- Radiological demonstration of posterolateral lumbar disc pulge by MRI lumbosacral
- Age range is between 30-80 years
Who cannot join
- The following patients will be excluded from the study:
- Patients with spinal deformities
- Patients with a previous history of spinal trauma
- Patients with previous spinal surgery
- Patients with radiological evidence of any inflammatory or neoplastic lesion affecting the spinal cord or vertebral column
- Patients with severe lumbar disc herniation causing lower limb weakness or sphincteric troubles
Show all 12Show fewer
- Patient with pain rather than radicular neuropathic pain as Facet osteoarthritis, Sacroiliitis, Hip osteoarthritis, Discogenic, Pyriformis syndrome.
- Patients with contraindications to interventions (coagulopathy, sepsis, or allergy to the used drugs)
- Patients with contraindications for MRI examination (e.g., metallic implants such as pacemakers, surgical aneurysm clips, or known metal fragments embedded in the body).
- Pregnant
- History of G6PD deficiency in patients who are candidates to receive ozone therapy.
- Suspected spondylodiscitis.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Wael Fathy Hassan
Banī Suwayf, 62511
Wael Fathy, Lecturer, 01006527133, drwaelfathy@yahoo.com
About this study
Chronic lumbar radicular (CLR) pain is a term used to describe neuropathic pain symptoms in the distribution of a particular lumbar nerve root due to disc protrusion, spinal stenosis, facet hypertrophy, or fibrosis after previous surgery. The pathophysiology of CLR pain involves mechanical, inflammatory, and immunologic factors that affect the function of the dorsal root ganglion (DRG).1Treatment methods include oral pain medications, physical therapy, epidural steroid injection (ESI) and surgery, among others. Both ESI and surgery appear to result in short-term pain relief relative to more conservative measures, yet neither is clearly superior to observation at 1-year follow-up (2,3).
Lumbar epidural steroid injection (LESI) was first suggested as a conservative treatment for radicular pain in 1952 by Robecchi and Capra,4 and it has since become one of the most commonly utilized conservative interventions for radiculopathy.5 Steroids are used to reduce inflammation in the epidural space.6-10 LESI is performed via a transforaminal (TF), caudal (C), or interlaminar (IL) approach in the lumbar spine; these approaches offer different advantages and disadvantages, which may result in different outcomes.11-14 The TF approach is perhaps the most favored because the injection site is adjacent to the nerve root, and only a small volume of medication is required for injection.15 The C route is both the easiest and the safest route and also seems to provide the most favorable analgesic effects. However, this approach requires relatively large volumes of medication and is less specific to the site of pathology.16 Previous studies have described the effectiveness of these methods in the management of radiculopathy.17-22 Magnesium sulfate has not been familiar to anesthesiologists until recently. It has drawn much attention in the field of anesthesiology,23,24 resulting in numerous publications of clinical studies, 25 review articles, and meta-analyses. 26 Based on its diverse roles in cellular functions, magnesium sulfate has been suggested to prevent excitotoxicity by its neuroprotective effects.27 Magnesium can antagonize NMDA receptor channels by blocking calcium influx in a voltage-gated manner. Intravenous administration of magnesium is efficacious in the management of various conditions associated with neuropathic pain. 28,29 Collins and colleagues reported that 70 mg/kg magnesium sulphate infusions in 4 hours for 5 days reduced pain in patients with complex regional pain syndrome. 30 Neuraxial administration of magnesium is an "off-label" use However, animal studies 31,32 showed that intrathecally administered magnesium was free of neurotoxicity, and recent studies have demonstrated the safety of magnesium administration via the epidural route in humans33,34.35 Recently, ozone therapy has emerged as an alternative or additional treatment option for patients with lumbar disc prolapse. Ozone (O 3 ) is an allotropic form of oxygen, primarily known for its ecological properties, industrial application and therapeutic effects. Questions persist concerning its potential toxicity as an oxidant agent versus its reported clinical efficacy. Several mechanisms of action have been proposed to explain the efficacy of ozone therapy including analgesic, anti-inflammatory and oxidant action. The O2-O3 gas mixture injected proximal to the root ganglion is thought to normalize the levels of cytokines and prostaglandins, increase superoxide dismutase levels minimize reactive oxidant species and improve local periganglionic circulation with eutropic effect on the nerve root36,37 Much concern was directed towardsthe contribution of oxidative stress to the pathophysiology of disc prolapse. More and more researchers devote themselves to elucidating the association between oxidative stress and disc degeneration. Antioxidative therapy is suggested as a promising therapeutic approach for preventing or retarding the establishment and progression of disc degeneration. The effect of interventional pain procedures for lumbar disc prolapse on oxidative stress biomarkers such as Glutathione and superoxide dismutase (SOD) remains unknown. 38
- Conditions
- Effect of Drug
- Being tested
- Transforaminal Epidural injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transforaminal Epidural injectionProcedure or surgery
Transforaminal injection will be performed under fluoroscopy guidance. The patient will be placed in the prone position and draped in the sterile manner. A 22-gauge, 3.5-inch spinal needle will be used. The selected patients will receive transforaminal epidural injection of the drug
| Study group | Role | What they receive |
|---|---|---|
| Magnesium sulphate group | Active comparator | Effect of transforaminal Magnesium sulphate on oxidative stress markers and radicular pain Receives: Procedure: Transforaminal Epidural injection |
| Ozone Group | Experimental | Effect of transforaminal Ozone on oxidative stress markers and radicular pain Receives: Procedure: Transforaminal Epidural injection |
| Steroid group | Other | Effect of transforaminal steroids on oxidative stress markers and radicular pain Receives: Procedure: Transforaminal Epidural injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxidative stress biomarkers
(Glutathione (GSH) and superoxide dismutase (SOD))
Measured: 2 weeks post intervention
Pain relief
Numeric Rating Scale
Measured: 3 months post intervention
Disability improvement
Numeric Rating Scale
Measured: 3 months post intervention
Secondary outcomes (1)
Patient satisfaction
The Short Assessment of Patient Satisfaction (SAPS)
Measured: 3 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start5 Oct 2020 (estimated)
- Primary completion5 Jan 2021 (estimated)
- Study completion5 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of DrugStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wael Fathy Hassan, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04562493
- Sponsor's protocol ID
- FMBSUREC/01122019/Hussein
- Status last verified
- Sep 2020
- First submitted
- 3 Sep 2020
- Last updated
- 24 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effect of Transforaminal Injection of Magnesium Sulphate Versus Ozone Therapy on Oxidative Stress Biomarkers in Lumbar Disc Related Radicular Pain
- ClinicalTrials.gov ID
- NCT04562493
- Acronym / sponsor ID
- FMBSUREC/01122019/Hussein
- Conditions
- Effect of Drug
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 5 Oct 2020 (estimated)
- Primary completion
- 5 Jan 2021 (estimated)
- Study completion
- 5 Apr 2021 (estimated)
- First posted
- 24 Sep 2020 (actual)
- 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.
Chronic lumbar radicular (CLR) pain is a term used to describe neuropathic pain symptoms in the distribution of a particular lumbar nerve root due to disc protrusion, spinal stenosis, facet hypertrophy, or fibrosis after previous surgery. The pathophysiology of CLR pain involves mechanical, inflammatory, and immunologic factors that affect the function of the dorsal root ganglion (DRG).1Treatment methods include oral pain medications, physical therapy, epidural steroid injection (ESI) and surgery, among others. Both ESI and surgery appear to result in short-term pain relief relative to more conservative measures, yet neither is clearly superior to observation at 1-year follow-up (2,3).
Lumbar epidural steroid injection (LESI) was first suggested as a conservative treatment for radicular pain in 1952 by Robecchi and Capra,4 and it has since become one of the most commonly utilized conservative interventions for radiculopathy.5 Steroids are used to reduce inflammation in the epidural space.6-10 LESI is performed via a transforaminal (TF), caudal (C), or interlaminar (IL) approach in the lumbar spine; these approaches offer different advantages and disadvantages, which may result in different outcomes.11-14 The TF approach is perhaps the most favored because the injection site is adjacent to the nerve root, and only a small volume of medication is required for injection.15 The C route is both the easiest and the safest route and also seems to provide the most favorable analgesic effects. However, this approach requires relatively large volumes of medication and is less specific to the site of pathology.16 Previous studies have described the effectiveness of these methods in the management of radiculopathy.17-22 Magnesium sulfate has not been familiar to anesthesiologists until recently. It has drawn much attention in the field of anesthesiology,23,24 resulting in numerous publications of clinical studies, 25 review articles, and meta-analyses. 26 Based on its diverse roles in cellular functions, magnesium sulfate has been suggested to prevent excitotoxicity by its neuroprotective effects.27 Magnesium can antagonize NMDA receptor channels by blocking calcium influx in a voltage-gated manner. Intravenous administration of magnesium is efficacious in the management of various conditions associated with neuropathic pain. 28,29 Collins and colleagues reported that 70 mg/kg magnesium sulphate infusions in 4 hours for 5 days reduced pain in patients with complex regional pain syndrome. 30 Neuraxial administration of magnesium is an "off-label" use However, animal studies 31,32 showed that intrathecally administered magnesium was free of neurotoxicity, and recent studies have demonstrated the safety of magnesium administration via the epidural route in humans33,34.35 Recently, ozone therapy has emerged as an alternative or additional treatment option for patients with lumbar disc prolapse. Ozone (O 3 ) is an allotropic form of oxygen, primarily known for its ecological properties, industrial application and therapeutic effects. Questions persist concerning its potential toxicity as an oxidant agent versus its reported clinical efficacy. Several mechanisms of action have been proposed to explain the efficacy of ozone therapy including analgesic, anti-inflammatory and oxidant action. The O2-O3 gas mixture injected proximal to the root ganglion is thought to normalize the levels of cytokines and prostaglandins, increase superoxide dismutase levels minimize reactive oxidant species and improve local periganglionic circulation with eutropic effect on the nerve root36,37 Much concern was directed towardsthe contribution of oxidative stress to the pathophysiology of disc prolapse. More and more researchers devote themselves to elucidating the association between oxidative stress and disc degeneration. Antioxidative therapy is suggested as a promising therapeutic approach for preventing or retarding the establishment and progression of disc degeneration. The effect of interventional pain procedures for lumbar disc prolapse on oxidative stress biomarkers such as Glutathione and superoxide dismutase (SOD) remains unknown. 38
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Magnesium sulphate group | Active comparator | Procedure: Transforaminal Epidural injectionEffect of transforaminal Magnesium sulphate on oxidative stress markers and radicular pain |
| Ozone Group | Experimental | Procedure: Transforaminal Epidural injectionEffect of transforaminal Ozone on oxidative stress markers and radicular pain |
| Steroid group | Other | Procedure: Transforaminal Epidural injectionEffect of transforaminal steroids on oxidative stress markers and radicular pain |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical evidence of disc pulge in the form of disc related radicular pain of >3 months duration, not responding to conservative treatment and interfering with daily activities
- Radiological demonstration of posterolateral lumbar disc pulge by MRI lumbosacral
- Age range is between 30-80 years
Key exclusion criteria (12 listed)
- Patients with spinal deformities
- Patients with a previous history of spinal trauma
- Patients with previous spinal surgery
- Patients with radiological evidence of any inflammatory or neoplastic lesion affecting the spinal cord or vertebral column
- Patients with severe lumbar disc herniation causing lower limb weakness or sphincteric troubles
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 |
|---|---|---|
| Transforaminal Epidural injectionTransforaminal injection will be performed under fluoroscopy guidance. The patient will be placed in the prone position and draped in the sterile manner. A 22-gauge, 3.5-inch spinal needle will be used. The selected patients will receive transforaminal epidural injection of the drug | Procedure or surgery | Magnesium sulphate group, Ozone Group, Steroid group |
Primary outcome
Oxidative stress biomarkers
Time frame: 2 weeks post intervention
(Glutathione (GSH) and superoxide dismutase (SOD))
Pain relief
Time frame: 3 months post intervention
Numeric Rating Scale
Disability improvement
Time frame: 3 months post intervention
Numeric Rating Scale
1 secondary outcome
Patient satisfaction
Time frame: 3 months post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transforaminal Epidural injection in people with Effect of Drug, run by Beni-Suef 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 4 inclusion and 12 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 24 Sep 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxidative stress biomarkers (time frame: 2 weeks post intervention). The study lists 3 primary outcomes in all. 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 24 Sep 2020.