- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04562493
Comparative Effect of Transforaminal Injection of Magnesium Sulphate Versus Ozone Therapy on Oxidative Stress Biomarkers in Lumbar Disc Related Radicular Pain
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Banī Suwayf, Egypt, 62511
- Wael Fathy Hassan
-
Contact:
- Wael Fathy, Lecturer
- Phone Number: 01006527133
- Email: drwaelfathy@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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
Exclusion Criteria:
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
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Magnesium sulphate group
Effect of transforaminal Magnesium sulphate on oxidative stress markers and radicular pain
|
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
|
Experimental: Ozone Group
Effect of transforaminal Ozone on oxidative stress markers and radicular pain
|
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
|
Other: Steroid group
Effect of transforaminal steroids on oxidative stress markers and radicular pain
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oxidative stress biomarkers
Time Frame: 2 weeks post intervention
|
(Glutathione (GSH) and superoxide dismutase (SOD))
|
2 weeks post intervention
|
Pain relief
Time Frame: 3 months post intervention
|
Numeric Rating Scale
|
3 months post intervention
|
Disability improvement
Time Frame: 3 months post intervention
|
Numeric Rating Scale
|
3 months post intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient satisfaction
Time Frame: 3 months post intervention
|
The Short Assessment of Patient Satisfaction (SAPS)
|
3 months post intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FMBSUREC/01122019/Hussein
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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