Lumbar Redicular PainNCT06656429
Outcome of Transforminal Epidural Injections in Patients with Lumbar Radicular Pain
A study testing Transforaminal Epidural Steroid Injections in people with Lumbar Redicular Pain, run by Muhammad Aamir Latif at 1 site in Pakistan.
Trial summary
Back pain is the most common chronic pain disorder of adult population. Lumbar radicular pain occurs due to irritation or compression of the nerve roots in the lower back. Various non-surgical methods can also be exercised that have been used to treat lumbar radicular pain since the ancient times. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Lumbar Redicular Pain
- What is being tested?
- Transforaminal Epidural Steroid Injections
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2021to 30 Sep 2022
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both genders
- Aged between 45 and 80 years
- Experiencing lumbar radicular pain
Who cannot join
- History of spinal fracture or previous spinal surgery
- Recurrent pain within 3 months of prior treatment
- Ongoing steroid therapy
- IKnown allergy to dexamethasone or lidocaine
Trial locations and contacts
1 site in 1 country.
About this study
Back pain is the most common chronic pain disorder of adult population. Lumbar radicular pain occurs due to irritation or compression of the nerve roots in the lower back. Various non-surgical methods can also be exercised that have been used to treat lumbar radicular pain since the ancient times. Despite the availability of various treatment options, achieving optimal pain relief and functional recovery remains challenging. Lumbar Transforaminal Epidural Steroid Injections (TFESI) are commonly used to manage this condition, but there is variability in patient response and limited data on the effectiveness of TFESI in different demographic and clinical subgroups.
- Conditions
- Lumbar Redicular Pain
- Being tested
- Transforaminal Epidural Steroid Injections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transforaminal Epidural Steroid InjectionsDrug
Also called Lumbar transforaminal epidural steroid Injection was administered, consisting of 4 mg dexamethasone and 0.33% lidocaine in a 3 ml solution
Transforaminal Epidural Steroid Injections
| Study group | Role | What they receive |
|---|---|---|
| TFESI | Experimental | Lumbar Transforaminal Epidural Steroid Injections was administered, consisting of 4 mg dexamethasone and 0.33% lidocaine in a 3 ml solution. Receives: Drug: Transforaminal Epidural Steroid Injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Patients were monitored for four weeks post-treatment, with follow-up visits scheduled at 1 week and 4 weeks. Pain scores were reassessed using visual analog scale (scores between 1 to 10). Lower scores meant lower pain whereas higher scores meant higher degree of pain
Measured: 4-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start1 Oct 2021
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Redicular PainStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Quasi-experimental study
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammad Aamir Latif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad Aamir Latif, RESnTEC, Institute of Research
- Investigators
- Muhammad Zarak Awais, MBBS, Principal investigator, Department of Orthopedic Surgery, Mayo Hospital, Lahore, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06656429
- Sponsor's protocol ID
- Mayo-1
- Status last verified
- Oct 2024
- First submitted
- 18 Oct 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Transforminal Epidural Injections in Patients with Lumbar Radicular Pain
- ClinicalTrials.gov ID
- NCT06656429
- Acronym / sponsor ID
- Mayo-1
- Conditions
- Lumbar Redicular Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Muhammad Aamir LatifUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 24 Oct 2024 (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.
Back pain is the most common chronic pain disorder of adult population. Lumbar radicular pain occurs due to irritation or compression of the nerve roots in the lower back. Various non-surgical methods can also be exercised that have been used to treat lumbar radicular pain since the ancient times. Despite the availability of various treatment options, achieving optimal pain relief and functional recovery remains challenging. Lumbar Transforaminal Epidural Steroid Injections (TFESI) are commonly used to manage this condition, but there is variability in patient response and limited data on the effectiveness of TFESI in different demographic and clinical subgroups.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Quasi-experimental study
| Arm | Type | Receives |
|---|---|---|
| TFESI | Experimental | Drug: Transforaminal Epidural Steroid InjectionsLumbar Transforaminal Epidural Steroid Injections was administered, consisting of 4 mg dexamethasone and 0.33% lidocaine in a 3 ml solution. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Both genders
- Aged between 45 and 80 years
- Experiencing lumbar radicular pain
Key exclusion criteria (4 listed)
- History of spinal fracture or previous spinal surgery
- Recurrent pain within 3 months of prior treatment
- Ongoing steroid therapy
- IKnown allergy to dexamethasone or lidocaine
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 Steroid InjectionsAlso: Lumbar transforaminal epidural steroid Injection was administered, consisting of 4 mg dexamethasone and 0.33% lidocaine in a 3 ml solutionTransforaminal Epidural Steroid Injections | Drug | TFESI |
Primary outcome
Pain score
Time frame: 4-week
Patients were monitored for four weeks post-treatment, with follow-up visits scheduled at 1 week and 4 weeks. Pain scores were reassessed using visual analog scale (scores between 1 to 10). Lower scores meant lower pain whereas higher scores meant higher degree of pain
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 24 Oct 2024.
- Individual participant dataSharing planned: No
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.
Muhammad Zarak Awais, MBBS principal investigator
Department of Orthopedic Surgery, Mayo Hospital, Lahore, Pakistan
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 Steroid Injections in people with Lumbar Redicular Pain, run by Muhammad Aamir Latif at 1 site in Pakistan.
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 4 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 24 Oct 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 Pakistan. 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: 4-week). 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 Oct 2024.