Lumbar RadiculopathyNCT05551676
Transforaminal and Parasagittal Approach in Lumbar Epidural Steroid Injection
A study testing transforaminal group and Lateral parasagittal group in people with Lumbar Radiculopathy, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Lumbar epidural injection is used in the treatment of lumbar radicular pain. There are three different application methods: lateral parasagittal, midline interlaminar and transforaminal epidural injection. Investigator aimed to compare lateral parasagittal and transforaminal epidural injection methods. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lumbar Radiculopathy
- What is being tested?
- transforaminal group and Lateral parasagittal group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Jun 2022to 22 Dec 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral low back pain, radiculopathy
Who cannot join
- malignancy
- past back surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Diskapi Yildirim Beyazıt Teaching and Research Hospital
Ankara
About this study
Official title: Comparison of Lateral Parasagittal Approach and Transforaminal Epidural Approach in Lumbar Epidural Steroid Injection
Lumbar epidural injection is used in the treatment of lumbar radicular pain. There are three different application methods: lateral parasagittal, midline interlaminar and transforaminal epidural injection. Investigator aimed to compare lateral parasagittal and transforaminal epidural injection methods. The purpose of the study is to determine which method is more efficient.
Read the detailed description
It was planned to recruit 60 participants in the study. Interlaminar epidural steroid injection will be applied to 30 patients with midline and 30 patients with lateral parasagittal approach. All patients will receive Oswestry disability index before and 2-4-12 weeks after the procedure. All patients will receive Somatization Amplification Scale (SSAS) before the treatment. The results of the patients will be compared. It will be investigated which method is more effective.
- Conditions
- Lumbar Radiculopathy
- Being tested
- transforaminal group, Lateral parasagittal group
- Keywords
- epidural steroid injection, transforaminal steroid injection, radicular pain
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transforaminal groupProcedure or surgery
Epidural steroid injection will be applied with transforaminal approach accompanied by fluoroscopy.
Lateral parasagittal groupProcedure or surgery
Epidural steroid injection will be applied with lateral parasagittal approach accompanied by scopy.
| Study group | Role | What they receive |
|---|---|---|
| Transforaminal group | Active comparator | Transforaminal steroid injection will be applied, 30 patients Receives: Procedure: transforaminal group |
| Lateral parasagittal group | Active comparator | Lateral parasagittal steroid injection will be applied, 30 patients Receives: Procedure: Lateral parasagittal group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry disability index
Oswestry Low Back Pain Disability Questionnaire, the Oswestry Disability Index helps to measure a patient's lower back pain. It evaluates the extent to which the patient's level of function is restricted by the pain, concentrating on the effects rather than the nature of the pain.
0% to 20%: minimal disability 41%-60%: severe disability 61%-80%: crippled
Measured: baseline, week 4, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start22 Jun 2022
- Primary completion22 Jun 2023 (estimated)
- Study completion22 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar RadiculopathyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damla Yürük, Diskapi Teaching and Research Hospital
- Investigators
- Ömer Taylan AKKAYA, Study director, Diskapi TRHHüseyin Alp Alptekin, Study chair, Diskapi TRHEzgi Can, Principal investigator, Diskapi TRH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551676
- Sponsor's protocol ID
- Lomber Epidural
- Status last verified
- Sep 2022
- First submitted
- 29 Aug 2022
- Last updated
- 23 Sep 2022
- 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 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Lateral Parasagittal Approach and Transforaminal Epidural Approach in Lumbar Epidural Steroid Injection
- ClinicalTrials.gov ID
- NCT05551676
- Acronym / sponsor ID
- Lomber Epidural
- Conditions
- Lumbar Radiculopathy
- Keywords
- epidural steroid injection, transforaminal steroid injection, radicular pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- 22 Jun 2023 (estimated)
- Study completion
- 22 Dec 2023 (estimated)
- First posted
- 23 Sep 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.
Lumbar epidural injection is used in the treatment of lumbar radicular pain. There are three different application methods: lateral parasagittal, midline interlaminar and transforaminal epidural injection. Investigator aimed to compare lateral parasagittal and transforaminal epidural injection methods. The purpose of the study is to determine which method is more efficient.
Detailed description
It was planned to recruit 60 participants in the study. Interlaminar epidural steroid injection will be applied to 30 patients with midline and 30 patients with lateral parasagittal approach. All patients will receive Oswestry disability index before and 2-4-12 weeks after the procedure. All patients will receive Somatization Amplification Scale (SSAS) before the treatment. The results of the patients will be compared. It will be investigated which method is more effective.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transforaminal group | Active comparator | Procedure: transforaminal groupTransforaminal steroid injection will be applied, 30 patients |
| Lateral parasagittal group | Active comparator | Procedure: Lateral parasagittal groupLateral parasagittal steroid injection will be applied, 30 patients |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Unilateral low back pain, radiculopathy
Key exclusion criteria (2 listed)
- malignancy
- past back surgery
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 groupEpidural steroid injection will be applied with transforaminal approach accompanied by fluoroscopy. | Procedure or surgery | Transforaminal group |
| Lateral parasagittal groupEpidural steroid injection will be applied with lateral parasagittal approach accompanied by scopy. | Procedure or surgery | Lateral parasagittal group |
Primary outcome
Oswestry disability index
Time frame: baseline, week 4, week 12
Oswestry Low Back Pain Disability Questionnaire, the Oswestry Disability Index helps to measure a patient's lower back pain. It evaluates the extent to which the patient's level of function is restricted by the pain, concentrating on the effects rather than the nature of the pain. 0% to 20%: minimal disability 41%-60%: severe disability 61%-80%: crippled
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
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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.
Ömer Taylan AKKAYA study director
Diskapi TRH
Hüseyin Alp Alptekin study chair
Diskapi TRH
Ezgi Can principal investigator
Diskapi TRH
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 group and Lateral parasagittal group in people with Lumbar Radiculopathy, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 2 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 23 Sep 2022. 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 Turkey (Türkiye). 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?
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?
Oswestry disability index (time frame: baseline, week 4, week 12). 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 23 Sep 2022.