Spinal StenosisNCT02838615
Comparison of Transforaminal vs. Parasagittal Interlaminar Epidural Injection
A study testing epidural steroid (dexamethasone) injection in people with Spinal Stenosis, run by Keimyung University Dongsan Medical Center.
Trial summary
The purpose of this study is to compare the clinical efficacy, incidence of ventral epidural spreading and provocation of concordant paresthesia, amount of radiation exposure and total procedure time between transforaminal and parasagittal interlaminar epidural injection. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spinal Stenosis
- What is being tested?
- epidural steroid (dexamethasone) injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Jun 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- central spinal stenosis
- herniated nucleus pulposus.
Who cannot join
- Lateral spinal stenosis
- Internal disc disruption
About this study
Official title: Comparison of Lumbar Epidural Steroid Injection: Transforaminal vs. Parasagittal Interlaminar Approach
The purpose of this study is to compare the clinical efficacy, incidence of ventral epidural spreading and provocation of concordant paresthesia, amount of radiation exposure and total procedure time between transforaminal and parasagittal interlaminar epidural injection.
Read the detailed description
Participants were randomly allocated to receive either parasagittal interlaminar or transforaminal ESI.
Investigators obtained clinical data including age, gender, duration of symptoms, predominant symptoms (axial pain vs. leg pain), severity of neurogenic intermittent claudication (NIC) and degree of depression. Depression was assessed by the Korean version of the Beck Depression Inventory (BDI). The BDI is a standardized questionnaire to assess cognitive, affective, and somatic symptoms of depression. All data were obtained before performing ESI.Data about anterior epidural spreading and presence of concordant pain provocation were obtained during fluoroscopic guided parasagittal interlaminar or transforaminal ESI. Also total procedure time and amount of radiation exposure were checked. Investigators observed the epidural spread pattern after a 2 ml injection of contrast material, confirmed anterior epidural spread with a lateral view, and asked the participants if they had any concordant pain provocation or not. The participants were asked if the pain was in the same distribution as their original pain (concordant) or dissimilar or absent in both quality and location.
Investigators used the numerical rating scale (NRS) as well as the Korean version of the Oswestry Disability Index (ODI) to evaluate clinical efficacy in terms of reducing pain and functional improvement at pretreatment and 2 weeks after the ESI series. ESI was performed twice with a 2 weeks interval before the final treatment outcome evaluation with the NRS and ODI. All patients reported average severity of their symptoms over the previous 1 week. A score of 0 on the NRS represents no pain, and a score of 10 represents the worst pain imaginable. The Korean version of the ODI (0-50) was used to assess functional improvement.
- Conditions
- Spinal Stenosis
- Being tested
- epidural steroid (dexamethasone) injection
- Keywords
- spinal stenosis, epidural steroid injection
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epidural steroid (dexamethasone) injectionProcedure or surgery
spinal injections performed in epidural space to relieve chronic low back pain or leg pain
| Study group | Role | What they receive |
|---|---|---|
| epidural steroid injection | Active comparator | TF epidural steroid (dexamethasone) injection Receives: Procedure: epidural steroid (dexamethasone) injection |
| IL epidural steroid injection | Active comparator | PS interlaminar epidural steroid(dexamethasone) injection Receives: Procedure: epidural steroid (dexamethasone) injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical efficacy
Numerical rating scale
Measured: 2 weeks after study completion
Secondary outcomes (2)
Intervention related time
time required to complete the intervention
Measured: 1 minutes after the completion of the intervention
Exposed radiation amount during intervention
Exposed radiation amount during intervention
Measured: 1 minutes after the completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionMay 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal StenosisStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Hee Hong, Keimyung University Dongsan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02838615
- Sponsor's protocol ID
- 2016-05-029
- Status last verified
- Nov 2017
- First submitted
- 25 May 2016
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Lumbar Epidural Steroid Injection: Transforaminal vs. Parasagittal Interlaminar Approach
- ClinicalTrials.gov ID
- NCT02838615
- Acronym / sponsor ID
- 2016-05-029
- Conditions
- Spinal Stenosis
- Keywords
- spinal stenosis, epidural steroid injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- May 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 20 Jul 2016 (estimated)
- 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.
The purpose of this study is to compare the clinical efficacy, incidence of ventral epidural spreading and provocation of concordant paresthesia, amount of radiation exposure and total procedure time between transforaminal and parasagittal interlaminar epidural injection.
Detailed description
Participants were randomly allocated to receive either parasagittal interlaminar or transforaminal ESI.
Investigators obtained clinical data including age, gender, duration of symptoms, predominant symptoms (axial pain vs. leg pain), severity of neurogenic intermittent claudication (NIC) and degree of depression. Depression was assessed by the Korean version of the Beck Depression Inventory (BDI). The BDI is a standardized questionnaire to assess cognitive, affective, and somatic symptoms of depression. All data were obtained before performing ESI.Data about anterior epidural spreading and presence of concordant pain provocation were obtained during fluoroscopic guided parasagittal interlaminar or transforaminal ESI. Also total procedure time and amount of radiation exposure were checked. Investigators observed the epidural spread pattern after a 2 ml injection of contrast material, confirmed anterior epidural spread with a lateral view, and asked the participants if they had any concordant pain provocation or not. The participants were asked if the pain was in the same distribution as their original pain (concordant) or dissimilar or absent in both quality and location.
Investigators used the numerical rating scale (NRS) as well as the Korean version of the Oswestry Disability Index (ODI) to evaluate clinical efficacy in terms of reducing pain and functional improvement at pretreatment and 2 weeks after the ESI series. ESI was performed twice with a 2 weeks interval before the final treatment outcome evaluation with the NRS and ODI. All patients reported average severity of their symptoms over the previous 1 week. A score of 0 on the NRS represents no pain, and a score of 10 represents the worst pain imaginable. The Korean version of the ODI (0-50) was used to assess functional improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| epidural steroid injection | Active comparator | Procedure: epidural steroid (dexamethasone) injectionTF epidural steroid (dexamethasone) injection |
| IL epidural steroid injection | Active comparator | Procedure: epidural steroid (dexamethasone) injectionPS interlaminar epidural steroid(dexamethasone) injection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- central spinal stenosis
- herniated nucleus pulposus.
Key exclusion criteria (2 listed)
- Lateral spinal stenosis
- Internal disc disruption
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 steroid (dexamethasone) injectionspinal injections performed in epidural space to relieve chronic low back pain or leg pain | Procedure or surgery | IL epidural steroid injection, epidural steroid injection |
Primary outcome
Clinical efficacy
Time frame: 2 weeks after study completion
Numerical rating scale
2 secondary outcomes
Intervention related time
Time frame: 1 minutes after the completion of the intervention
Exposed radiation amount during intervention
Time frame: 1 minutes after the completion of the intervention
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 Nov 2017.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing epidural steroid (dexamethasone) injection in people with Spinal Stenosis, run by Keimyung University Dongsan Medical Center.
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 2 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: finished, as of the sponsor's last update on 29 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Clinical efficacy (time frame: 2 weeks after study completion). 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 Nov 2017.