Failed Back Surgery SyndromeNCT05099796
Epidural Steroid Injections in Post-lumbar Surgery Syndrome After Single-level Discectomy
A study testing Transforaminal epidural steroid injection and Caudal epidural steroid injection in people with Failed Back Surgery Syndrome and Low Back Pain, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
62 patients with postlumbar surgery syndrome were randomized and divided into two groups. Transforaminal epidural steroid injection (TFESI) was applied to the TFESI group (n=31), and caudal epidural steroid injection (CESI) was applied to the CESI group (n=31). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Failed Back Surgery Syndrome, Low Back Pain, Radiculopathy
- What is being tested?
- Transforaminal epidural steroid injection and Caudal epidural steroid injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2016to 11 May 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years
- Previous single-level, open, non-fusion discectomy for L4-5 or L5-S1 lumbar disc herniation within the past six months
- Having epidural fibrosis involving the L4, L5 or S1 nerve root on magnetic resonance imaging
- Having low back and leg pain for at least six months and unresponsive to conservative therapies
- A Numerical Rating Scale score of ≥4
- Having a single-level epidural fibrosis in the operated level and side as assessed by contrast-enhanced spinal magnetic resonance imaging
Who cannot join
- Having a multi-level epidural fibrosis
- Previous surgery for multi-level disc herniation
- Previous lumbar fusion surgery
- Having recurrent disc hernia
- Having sacroiliac/facet joint pain
- Having lumbar spinal stenosis, spondylolysis, spondylolisthesis, or scoliosis
Show all 11Show fewer
- History of epidural steroid injection within the past six months
- Having bleeding diathesis
- Presence of systemic or local infections
- Pregnancy
- Known hypersensitivity to the injectates to be applied
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Pendik Training and Research Hospital
Istanbul
About this study
Official title: Comparison of Caudal Versus Transforaminal Epidural Steroid Injection in Post-lumbar Surgery Syndrome After Single-level Discectomy: A Prospective, Randomized Clinical Trial
62 patients with postlumbar surgery syndrome were randomized and divided into two groups. Transforaminal epidural steroid injection (TFESI) was applied to the TFESI group (n=31), and caudal epidural steroid injection (CESI) was applied to the CESI group (n=31). The age of the patients involved in this study ranged from 18 years old to 65 years old
Read the detailed description
Patients with low back and radicular pain related to epidural fibrosis following single-level lumbar discectomy were included. The patients were randomly divided into two groups as the CESI group and TFESI group. Transforaminal epidural steroid injection was applied to the TFESI group (n=31), and caudal epidural steroid injection was applied to the CESI group (n=31). All patients were assessed before the procedure (baseline) and at 1 hour, three weeks, and three months after the procedure using the Numerical Rating Scale (NRS) and at baseline and three weeks and three months using the modified Oswestry Disability Index (mODI). Treatment success was defined as ≥50% decrease in the NRS scores compared to baseline
- Being tested
- Transforaminal epidural steroid injection, Caudal epidural steroid injection
- Keywords
- Failed back surgery syndrome, epidural steroid injections
- Medical subject headings
- Failed Back Surgery Syndrome, Low Back Pain, Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transforaminal epidural steroid injectionProcedure or surgery
Caudal epidural steroid injectionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Transforaminal epidural steroid injection (TESI) group | Active comparator | This procedure was applied only once.
1 to 2 cc of the contrast agent (300 mg/50 mL iohexol) was given and the distribution pattern was visualized. Once the epidural distribution of the contrast agent was confirmed without vascular flow, a mixture of 40 mg (1mL) of triamcinolone acetonide, 2 cc of physiological saline, and 2 cc (0.5%) of bupivacaine was injected. Receives: Procedure: Transforaminal epidural steroid injection |
| Caudal epidural steroid injection (CESI) group | Active comparator | This procedure was applied only once
1 to 2 cc of the contrast agent (300 mg/50 mL iohexol) was given and the distribution pattern was visualized which showed bilateral L5-S3 distribution without vascular flow. A mixture of 40 mg (1mL) of triamcinolone acetonide, 7 cc of physiological saline, and 2 cc (0.5%) of bupivacaine was injected. A total of 10 cc mixture was used for CESI. Receives: Procedure: Caudal epidural steroid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain severity
Numerical Rating Scale (NRS) is a scale for assessing the severity of pain. The numerical rating scale ranges from 0 to 10, with 0 being "no pain" and 10 being "worst pain imaginable". The patient chooses the most appropriate number describing the severity of pain (oral version).
Measured: All patients were assessed from baseline to each checkpoint (at 1 hour, three weeks, and three months after the procedure)
Change in disability score
Modified Oswestry Disability Index (MODI) is a 10-question questionnaire assessing disability in low back pain. Each question has 6 options. The lowest score for each question is zero and the highest score is 5. High score is associated with increased disability.
Measured: All patients were assessed from baseline to each checkpoint (at 1 hour, three weeks, and three months after the procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start5 Jan 2016
- Primary completion11 May 2021
- Study completion11 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Failed Back Surgery SyndromeStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Savas Sencan, Assoc. Prof., Study director, Marmara University Pendik Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05099796
- Sponsor's protocol ID
- 09.2014.0085
- Status last verified
- Oct 2021
- First submitted
- 11 Oct 2021
- Last updated
- 29 Oct 2021
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Caudal Versus Transforaminal Epidural Steroid Injection in Post-lumbar Surgery Syndrome After Single-level Discectomy: A Prospective, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05099796
- Acronym / sponsor ID
- 09.2014.0085
- Keywords
- Failed back surgery syndrome, epidural steroid injections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 5 Jan 2016 (actual)
- Primary completion
- 11 May 2021 (actual)
- Study completion
- 11 May 2021 (actual)
- First posted
- 29 Oct 2021 (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.
62 patients with postlumbar surgery syndrome were randomized and divided into two groups. Transforaminal epidural steroid injection (TFESI) was applied to the TFESI group (n=31), and caudal epidural steroid injection (CESI) was applied to the CESI group (n=31). The age of the patients involved in this study ranged from 18 years old to 65 years old
Detailed description
Patients with low back and radicular pain related to epidural fibrosis following single-level lumbar discectomy were included. The patients were randomly divided into two groups as the CESI group and TFESI group. Transforaminal epidural steroid injection was applied to the TFESI group (n=31), and caudal epidural steroid injection was applied to the CESI group (n=31). All patients were assessed before the procedure (baseline) and at 1 hour, three weeks, and three months after the procedure using the Numerical Rating Scale (NRS) and at baseline and three weeks and three months using the modified Oswestry Disability Index (mODI). Treatment success was defined as ≥50% decrease in the NRS scores compared to baseline
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transforaminal epidural steroid injection (TESI) group | Active comparator | Procedure: Transforaminal epidural steroid injectionThis procedure was applied only once. 1 to 2 cc of the contrast agent (300 mg/50 mL iohexol) was given and the distribution pattern was visualized. Once the epidural distribution of the contrast agent was confirmed without vascular flow, a mixture of 40 mg (1mL) of triamcinolone acetonide, 2 cc of physiological saline, and 2 cc (0.5%) of bupivacaine was injected. |
| Caudal epidural steroid injection (CESI) group | Active comparator | Procedure: Caudal epidural steroid injectionThis procedure was applied only once 1 to 2 cc of the contrast agent (300 mg/50 mL iohexol) was given and the distribution pattern was visualized which showed bilateral L5-S3 distribution without vascular flow. A mixture of 40 mg (1mL) of triamcinolone acetonide, 7 cc of physiological saline, and 2 cc (0.5%) of bupivacaine was injected. A total of 10 cc mixture was used for CESI. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 and 65 years
- Previous single-level, open, non-fusion discectomy for L4-5 or L5-S1 lumbar disc herniation within the past six months
- Having epidural fibrosis involving the L4, L5 or S1 nerve root on magnetic resonance imaging
- Having low back and leg pain for at least six months and unresponsive to conservative therapies
- A Numerical Rating Scale score of ≥4
Key exclusion criteria (11 listed)
- Having a multi-level epidural fibrosis
- Previous surgery for multi-level disc herniation
- Previous lumbar fusion surgery
- Having recurrent disc hernia
- Having sacroiliac/facet joint pain
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 injection | Procedure or surgery | Transforaminal epidural steroid injection (TESI) group |
| Caudal epidural steroid injection | Procedure or surgery | Caudal epidural steroid injection (CESI) group |
Primary outcome
Change in pain severity
Time frame: All patients were assessed from baseline to each checkpoint (at 1 hour, three weeks, and three months after the procedure)
Numerical Rating Scale (NRS) is a scale for assessing the severity of pain. The numerical rating scale ranges from 0 to 10, with 0 being "no pain" and 10 being "worst pain imaginable". The patient chooses the most appropriate number describing the severity of pain (oral version).
Change in disability score
Time frame: All patients were assessed from baseline to each checkpoint (at 1 hour, three weeks, and three months after the procedure)
Modified Oswestry Disability Index (MODI) is a 10-question questionnaire assessing disability in low back pain. Each question has 6 options. The lowest score for each question is zero and the highest score is 5. High score is associated with increased disability.
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 29 Oct 2021.
- 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.
Savas Sencan, Assoc. Prof. study director
Marmara University Pendik Training and Research Hospital
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 injection and Caudal epidural steroid injection in people with Failed Back Surgery Syndrome and Low Back Pain, run by Marmara University 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 6 inclusion and 11 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 29 Oct 2021. 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?
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?
Change in pain severity (time frame: All patients were assessed from baseline to each checkpoint (at 1 hour, three weeks, and three months after the procedure)). The study lists 2 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 29 Oct 2021.