Unilateral Lumbosacral Radiculopathy PainNCT01760317
Two Different Approaches During Fluoroscopically Guided Interlaminar Lumbar Epidural Steroid Injection
A study testing Midline vs Parasagittal Lumbar Epidural Steroid Injection in people with Unilateral Lumbosacral Radiculopathy Pain, run by Kenneth D Candido at 1 site in United States.
Trial summary
The purpose of this study is to compare two different approaches (midline and parasagittal) during interlaminar lumbar epidural steroid injection (LESI), and to verify the role of concordant pressure paresthesia occurring during the LESI in determining outcome. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Unilateral Lumbosacral Radiculopathy Pain
- What is being tested?
- Midline vs Parasagittal Lumbar 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
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to May 2013
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18- 80 years old
- History of low back pain and unilateral lumbosacral radiculopathy pain
- Lumbar disk disease including disk herniations, bulging discs, and degenerated discs, where at least 50% of the disk height is preserved respective to contiguous levels
Who cannot join
- Discogenic pain without radiculopathy pain
- History of previous spinal surgery
- LESI(s) in the past year
- Allergy to methylprednisolone, or lidocaine, or iodine-based contrast
- Concurrent use of systemic steroid medications
- Opioid habituation
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Chicago Anesthesia Pain Specialits
Chicago, Illinois, 60657
About this study
Official title: Midline vs Lateral Parasagittal Approach During Fluoroscopically Guided Interlaminar Lumbar Epidural Steroid Injection: the Role of Concordant Pressure Paresthesia in Determing Outcome.
The purpose of this study is to compare two different approaches (midline and parasagittal) during interlaminar lumbar epidural steroid injection (LESI), and to verify the role of concordant pressure paresthesia occurring during the LESI in determining outcome.
The investigators are planning to include 100 patients, undergoing LESI for radicular low back pain. This will be single-blinded randomized study. Every patient will receive the same medication we would use regardless of participating in the study. The patients will be randomly assigned to one of two groups, based on the approach:
- Group I (50 patients) - will get LESI using midline (MIL) approach.
- Group II (50 patients) - will get LESI using parasagittal interlaminar (PIL) approach.
- Being tested
- Midline vs Parasagittal Lumbar Epidural Steroid Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midline vs Parasagittal Lumbar Epidural Steroid InjectionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Midline | Active comparator | Midline Lumbar Epidural Steroid Injection Receives: Procedure: Midline vs Parasagittal Lumbar Epidural Steroid Injection |
| Parasagittal | Active comparator | Parasagittal Lumbar Epidural Steroid Injection Receives: Procedure: Midline vs Parasagittal Lumbar Epidural Steroid Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Pain Scores from baseline after Lumbar Epidural Steroid Injection
Measured: Days 1, 7, 14, 21, 28, 60, 120, 180, 360
Pressure Paresthesia during injection
Measured: 1 day (During Lumbar Epidural Steroid Injection)
Quality of life improvement change after Lumbar Epidural Steroid Injection
Measured: Days 1, 7, 14, 21, 28, 60, 120, 180, 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startAug 2010
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Unilateral Lumbosacral Radiculopathy 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kenneth D Candido
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kenneth D Candido, Chicago Anesthesia Pain Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01760317
- Sponsor's protocol ID
- Advocate-IRB-4917
- Status last verified
- Feb 2015
- First submitted
- 21 Dec 2012
- Last updated
- 5 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Boswell MV, Shah RV, Everett CR, Sehgal N, McKenzie Brown AM, Abdi S, Bowman RC 2nd, Deer TR, Datta S, Colson JD, Spillane WF, Smith HS, Lucas LF, Burton AW, Chopra P, Staats PS, Wasserman RA, Manchikanti L. Interventional techniques in the management of chronic spinal pain: evidence-based practice guidelines. Pain Physician. 2005 Jan;8(1):1-47.
PubMed 16850041Abdi S, Datta S, Trescot AM, Schultz DM, Adlaka R, Atluri SL, Smith HS, Manchikanti L. Epidural steroids in the management of chronic spinal pain: a systematic review. Pain Physician. 2007 Jan;10(1):185-212.
PubMed 17256030Manchikanti L. The growth of interventional pain management in the new millennium: a critical analysis of utilization in the medicare population. Pain Physician. 2004 Oct;7(4):465-82.
PubMed 16858489Boswell MV, Trescot AM, Datta S, Schultz DM, Hansen HC, Abdi S, Sehgal N, Shah RV, Singh V, Benyamin RM, Patel VB, Buenaventura RM, Colson JD, Cordner HJ, Epter RS, Jasper JF, Dunbar EE, Atluri SL, Bowman RC, Deer TR, Swicegood JR, Staats PS, Smith HS, Burton AW, Kloth DS, Giordano J, Manchikanti L; American Society of Interventional Pain Physicians. Interventional techniques: evidence-based practice guidelines in the management of chronic spinal pain. Pain Physician. 2007 Jan;10(1):7-111.
PubMed 17256025Buenaventura RM, Datta S, Abdi S, Smith HS. Systematic review of therapeutic lumbar transforaminal epidural steroid injections. Pain Physician. 2009 Jan-Feb;12(1):233-51.
PubMed 19165306Candido KD, Raghavendra MS, Chinthagada M, Badiee S, Trepashko DW. A prospective evaluation of iodinated contrast flow patterns with fluoroscopically guided lumbar epidural steroid injections: the lateral parasagittal interlaminar epidural approach versus the transforaminal epidural approach. Anesth Analg. 2008 Feb;106(2):638-44, table of contents. doi: 10.1213/ane.0b013e3181605e9b.
PubMed 18227326
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Midline vs Lateral Parasagittal Approach During Fluoroscopically Guided Interlaminar Lumbar Epidural Steroid Injection: the Role of Concordant Pressure Paresthesia in Determing Outcome.
- ClinicalTrials.gov ID
- NCT01760317
- Acronym / sponsor ID
- Advocate-IRB-4917
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Kenneth D CandidoUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 4 Jan 2013 (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 two different approaches (midline and parasagittal) during interlaminar lumbar epidural steroid injection (LESI), and to verify the role of concordant pressure paresthesia occurring during the LESI in determining outcome.
The investigators are planning to include 100 patients, undergoing LESI for radicular low back pain. This will be single-blinded randomized study. Every patient will receive the same medication we would use regardless of participating in the study. The patients will be randomly assigned to one of two groups, based on the approach:
- Group I (50 patients) - will get LESI using midline (MIL) approach.
- Group II (50 patients) - will get LESI using parasagittal interlaminar (PIL) approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midline | Active comparator | Procedure: Midline vs Parasagittal Lumbar Epidural Steroid InjectionMidline Lumbar Epidural Steroid Injection |
| Parasagittal | Active comparator | Procedure: Midline vs Parasagittal Lumbar Epidural Steroid InjectionParasagittal Lumbar Epidural Steroid Injection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18- 80 years old
- History of low back pain and unilateral lumbosacral radiculopathy pain
- Lumbar disk disease including disk herniations, bulging discs, and degenerated discs, where at least 50% of the disk height is preserved respective to contiguous levels
Key exclusion criteria (7 listed)
- Discogenic pain without radiculopathy pain
- History of previous spinal surgery
- LESI(s) in the past year
- Allergy to methylprednisolone, or lidocaine, or iodine-based contrast
- Concurrent use of systemic steroid medications
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 |
|---|---|---|
| Midline vs Parasagittal Lumbar Epidural Steroid Injection | Procedure or surgery | Midline, Parasagittal |
Primary outcome
Changes in Pain Scores from baseline after Lumbar Epidural Steroid Injection
Time frame: Days 1, 7, 14, 21, 28, 60, 120, 180, 360
Pressure Paresthesia during injection
Time frame: 1 day (During Lumbar Epidural Steroid Injection)
Quality of life improvement change after Lumbar Epidural Steroid Injection
Time frame: Days 1, 7, 14, 21, 28, 60, 120, 180, 360
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 5 Feb 2015.
- Background: PubMed 16850041Boswell MV, Shah RV, Everett CR, Sehgal N, McKenzie Brown AM, Abdi S, Bowman RC 2nd, Deer TR, Datta S, Colson JD, Spillane WF, Smith HS, Lucas LF, Burton AW, Chopra P, Staats PS, Wasserman RA, Manchikanti L. Interventional techniques in the management of chronic spinal pain: evidence-based practice guidelines. Pain Physician. 2005 Jan;8(1):1-47.
- Background: PubMed 17256030Abdi S, Datta S, Trescot AM, Schultz DM, Adlaka R, Atluri SL, Smith HS, Manchikanti L. Epidural steroids in the management of chronic spinal pain: a systematic review. Pain Physician. 2007 Jan;10(1):185-212.
- Background: PubMed 16858489Manchikanti L. The growth of interventional pain management in the new millennium: a critical analysis of utilization in the medicare population. Pain Physician. 2004 Oct;7(4):465-82.
- Background: PubMed 17256025Boswell MV, Trescot AM, Datta S, Schultz DM, Hansen HC, Abdi S, Sehgal N, Shah RV, Singh V, Benyamin RM, Patel VB, Buenaventura RM, Colson JD, Cordner HJ, Epter RS, Jasper JF, Dunbar EE, Atluri SL, Bowman RC, Deer TR, Swicegood JR, Staats PS, Smith HS, Burton AW, Kloth DS, Giordano J, Manchikanti L; American Society of Interventional Pain Physicians. Interventional techniques: evidence-based practice guidelines in the management of chronic spinal pain. Pain Physician. 2007 Jan;10(1):7-111.
- Background: PubMed 19165306Buenaventura RM, Datta S, Abdi S, Smith HS. Systematic review of therapeutic lumbar transforaminal epidural steroid injections. Pain Physician. 2009 Jan-Feb;12(1):233-51.
- Background: PubMed 18227326Candido KD, Raghavendra MS, Chinthagada M, Badiee S, Trepashko DW. A prospective evaluation of iodinated contrast flow patterns with fluoroscopically guided lumbar epidural steroid injections: the lateral parasagittal interlaminar epidural approach versus the transforaminal epidural approach. Anesth Analg. 2008 Feb;106(2):638-44, table of contents. doi: 10.1213/ane.0b013e3181605e9b.
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 Midline vs Parasagittal Lumbar Epidural Steroid Injection in people with Unilateral Lumbosacral Radiculopathy Pain, run by Kenneth D Candido at 1 site in United States.
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 7 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 5 Feb 2015. 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 United States. 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?
Changes in Pain Scores from baseline after Lumbar Epidural Steroid Injection (time frame: Days 1, 7, 14, 21, 28, 60, 120, 180, 360). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01760317, which also lists 6 linked publications.
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 5 Feb 2015.