Chronic PainNCT05271721
Trans-foraminal Lumbar Epidural Injection of Dexmedetomidine Against Magnesium Sulfate When Combined With Dexamethasone in Uni-lateral Lower Limb Radicular Pain. Multi-centeric Comparative Study
A study testing epidural transforaminal injection of magnesuim sulfate, epidural transforaminal injection of dexmedtemodine and transforaminal epidural injection of dexamethasone in people with Chronic Pain, run by Minia University at 1 site in Egypt.
Trial summary
Transforaminal injection of chronic radicular lower limb injection by either dexmedetomdine or magnesuim sulfate Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- epidural transforaminal injection of magnesuim sulfate, epidural transforaminal injection of dexmedtemodine and transforaminal epidural injection of dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2022to 1 May 2023
- 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age group. 25-75ys old
- Both sex.
- Lumber disc protrusion at one or two segments on MRI.
- Chronic lumbar radiculer pain for more than 6 weeks refractory to
- medical treatment for at least 4 weeks. .
- Positve leg rising test at 30-70 degrees.
Who cannot join
- Diabetic candidates ( type Ior II).
- Patient refusal.
- MRI with disc sequestration.
- Neurological examination revealed foot drop, neuropathic ulcers
- Myelopathic or scoliotic patients, .
- Coagulopathic patients ( cirrhotic patients, on anti-coagulation )
Trial locations and contacts
1 site in 1 country.
About this study
Transforaminal injection of chronic radicular lower limb injection by either dexmedetomdine or magnesuim sulfate
- Conditions
- Chronic Pain
- Being tested
- epidural transforaminal injection of magnesuim sulfate, epidural transforaminal injection of dexmedtemodine, transforaminal epidural injection of dexamethasone
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epidural transforaminal injection of magnesuim sulfateDrug
Also called floroscopic epidural injection of magnesuim
transforaminal fluroscopic guided
epidural transforaminal injection of dexmedtemodineDrug
Also called fluroscopic eoidural injection of dexmedtemodine
transforaminal fluroscopic guided
transforaminal epidural injection of dexamethasoneDrug
Also called fluroscopic epidural injection of dexamethasone
transforaminal fluroscopic guided
| Study group | Role | What they receive |
|---|---|---|
| control group | Other | Dexamethasone 4 mg (1ml) plus 40 mg ( 2ml) lidocaine 2% plus 1ml sterile saline Receives: Drug: transforaminal epidural injection of dexamethasone |
| Magnesuim group | Active comparator | . 200 mg Mg sulfate (1ml) plus 4 mg dexamethasone(1ml) plus 40mg lidocaine 2% (2ml) Receives: Drug: epidural transforaminal injection of magnesuim sulfate |
| Dexmedetomidine group | Active comparator | Dexmedetmodine 50mic (0.5ml) ,4 mg dexamethasone (1ml), 40 mg lidocaine 2% (2ml) added to 4ml total volume with sterile saline . Receives: Drug: epidural transforaminal injection of dexmedtemodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score
visual analogue pain score. pain value of (0 cm) equals no pain , and value of (10 cm) equals worst pain
Measured: up to 6 months post-injection
Secondary outcomes (2)
functional disability
Modified Oswestry Disability Questionnaire....0% to 20%: minimal disability:....21%-40%: moderate disability: 41%-60%: severe disability...61%-80%: crippled
Measured: up to 6 months post injection
acute complications
number of patients developed epidural hematoma by magnetic resonance imaging
Measured: 6 hours post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start1 Mar 2022
- Primary completion10 Feb 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Minia 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Maher, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271721
- Sponsor's protocol ID
- R/219
- Status last verified
- Jul 2024
- First submitted
- 26 Feb 2022
- Last updated
- 3 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans-foraminal Lumbar Epidural Injection of Dexmedetomidine Against Magnesium Sulfate When Combined With Dexamethasone in Uni-lateral Lower Limb Radicular Pain. Multi-centeric Comparative Study
- ClinicalTrials.gov ID
- NCT05271721
- Acronym / sponsor ID
- R/219
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 10 Feb 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 9 Mar 2022 (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.
Transforaminal injection of chronic radicular lower limb injection by either dexmedetomdine or magnesuim sulfate
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | Other | Drug: transforaminal epidural injection of dexamethasoneDexamethasone 4 mg (1ml) plus 40 mg ( 2ml) lidocaine 2% plus 1ml sterile saline |
| Magnesuim group | Active comparator | Drug: epidural transforaminal injection of magnesuim sulfate. 200 mg Mg sulfate (1ml) plus 4 mg dexamethasone(1ml) plus 40mg lidocaine 2% (2ml) |
| Dexmedetomidine group | Active comparator | Drug: epidural transforaminal injection of dexmedtemodineDexmedetmodine 50mic (0.5ml) ,4 mg dexamethasone (1ml), 40 mg lidocaine 2% (2ml) added to 4ml total volume with sterile saline . |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age group. 25-75ys old
- Both sex.
- Lumber disc protrusion at one or two segments on MRI.
- Chronic lumbar radiculer pain for more than 6 weeks refractory to
- medical treatment for at least 4 weeks. .
Key exclusion criteria (6 listed)
- Diabetic candidates ( type Ior II).
- Patient refusal.
- MRI with disc sequestration.
- Neurological examination revealed foot drop, neuropathic ulcers
- Myelopathic or scoliotic patients, .
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 |
|---|---|---|
| epidural transforaminal injection of magnesuim sulfateAlso: floroscopic epidural injection of magnesuimtransforaminal fluroscopic guided | Drug | Magnesuim group |
| epidural transforaminal injection of dexmedtemodineAlso: fluroscopic eoidural injection of dexmedtemodinetransforaminal fluroscopic guided | Drug | Dexmedetomidine group |
| transforaminal epidural injection of dexamethasoneAlso: fluroscopic epidural injection of dexamethasonetransforaminal fluroscopic guided | Drug | control group |
Primary outcome
pain score
Time frame: up to 6 months post-injection
visual analogue pain score. pain value of (0 cm) equals no pain , and value of (10 cm) equals worst pain
2 secondary outcomes
functional disability
Time frame: up to 6 months post injection
acute complications
Time frame: 6 hours post-injection
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 3 Jul 2024.
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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.
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 epidural transforaminal injection of magnesuim sulfate, epidural transforaminal injection of dexmedtemodine and transforaminal epidural injection of dexamethasone in people with Chronic Pain, run by Minia 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 6 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 3 Jul 2024. 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 score (time frame: up to 6 months post-injection). 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 3 Jul 2024.