Low Back PainNCT00681447
Treatment of Chronic Low Back and Lower Extremity Pain
A study testing Lumbar Interlaminar Epidural and Lumbar Interlaminar Epidural injection in people with Low Back Pain, run by Pain Management Center of Paducah at 1 site in United States.
Trial summary
1. To demonstrate clinically significant improvements in patients undergoing lumbar interlaminar epidurals. Improvement will be assessed in relation to the clinical outcome measures of pain and function. 2. To evaluate and compare the adverse event profile in all patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Lumbar Interlaminar Epidural and Lumbar Interlaminar Epidural injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Dec 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects of at least 18 years of age
- Subjects with a history of chronic, function-limiting chronic low back pain of at least 6 months in duration
- Subjects who are able to give voluntary, written informed consent to participate in this investigation
- Subjects who, in the opinion of the PI, are able to understand this investigation, co-operate with the investigational procedures, and are willing to return to the center for all the required post-operative follow-ups
- Subjects have not had recent surgical procedures within the last 3 months.
Who cannot join
- Cauda Equina symptoms and/or compressive radiculopathy
- Narcotic use of no greater than hydrocodone 100 mg/day, methadone of 60 mg, or morphine 180 mg, or dose equivalent
- Uncontrolled major depression or uncontrolled psychiatric disorders
- Uncontrolled or acute medical illnesses including coagulopathy, renal insufficiency, chronic liver dysfunction, progressive neurological deficit, urinary sphincter dysfunction, infection, increased intracranial pressure, pseudotumor cerebri, intracranial tumors, unstable angina, and severe chronic obstructive pulmonary disease.
- Chronic severe conditions that could interfere with the interpretations of the outcome assessments for pain and bodily function
- Women who are pregnant or lactating
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- Subjects who have participated in a clinical study with an investigational product within 30 days of enrollment
- Patients with multiple complaints involving concomitant hip osteoarthritis, due to the overlap of pain complaints
- Inability to achieve appropriate positioning and inability to understand informed consent and protocol
- History of adverse reaction to local anesthetic or anti-inflammatory drugs and history of gastrointestinal bleeding or ulcers
- Previous surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Prospective, Double-Blind Controlled Evaluation of the Effectiveness of Lumbar Interlaminar Epidural Injections in Lumbar Disc Herniation, and Discogenic Pain
- To demonstrate clinically significant improvements in patients undergoing lumbar interlaminar epidurals. Improvement will be assessed in relation to the clinical outcome measures of pain and function.
- To evaluate and compare the adverse event profile in all patients.
- Conditions
- Low Back Pain
- Being tested
- Lumbar Interlaminar Epidural, Lumbar Interlaminar Epidural injection
- Keywords
- lumbar disc herniation, discogenic pain, lumbar interlaminar epidural, injections
- Medical subject headings
- Low Back Pain, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar Interlaminar EpiduralProcedure or surgery
- Lumbar interlaminar epidural injections under fluoroscopy
- Epidural tray and needle
- Drugs:
0.5% Xylocaine and non-particulate Celestone
Lumbar Interlaminar Epidural injectionProcedure or surgery
- Lumbar interlaminar epidural injections under fluoroscopy
- Epidural tray and needle
- Drugs:
0.5% Xylocaine and non-particulate Celestone
| Study group | Role | What they receive |
|---|---|---|
| Group I | Other | Lumbar interlaminar epidural injection with local anesthetic only Receives: Procedure: Lumbar Interlaminar Epidural; Procedure: Lumbar Interlaminar Epidural injection |
| Group II | Other | Lumbar Interlaminar Epidural Injection with local anesthetic wiht 6 mg of non-particulate Celestone Receives: Procedure: Lumbar Interlaminar Epidural; Procedure: Lumbar Interlaminar Epidural injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate clinically significant improvement or lack thereof with the lumbar interlaminar epidural patients with or without steroids.
Measured: Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months.
Secondary outcomes (2)
To evaluate differences in outcomes in patients receiving steroids compared to those patients randomized to the local anesthetic group who did not receive steroids.
Measured: Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months.
To evaluate and compare the adverse event profile in all patients.
Measured: Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2008 (estimated)
- Study startFeb 2008
- Primary completionFeb 2010
- Study completionDec 2014
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 Low Back 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pain Management Center of Paducah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laxmaiah Manchikanti, MD, Pain Management Center of Paducah
- Investigators
- Laxmaiah Manchikanti, MD, Principal investigator, Ambulatory Surgery Center, Paducah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00681447
- Sponsor's protocol ID
- protocol 15
- Status last verified
- Oct 2015
- First submitted
- 14 Mar 2008
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Manchikanti L, Cash KA, McManus CD, Damron KS, Pampati V, Falco FJ. A randomized, double-blind controlled trial of lumbar interlaminar epidural injections in central spinal stenosis: 2-year follow-up. Pain Physician. 2015 Jan-Feb;18(1):79-92.
PubMed 25675062Manchikanti L, Singh V, Cash KA, Pampati V, Falco FJ. A randomized, double-blind, active-control trial of the effectiveness of lumbar interlaminar epidural injections in disc herniation. Pain Physician. 2014 Jan-Feb;17(1):E61-74.
PubMed 24452658Manchikanti L, Cash KA, McManus CD, Pampati V, Benyamin RM. A randomized, double-blind, active-controlled trial of fluoroscopic lumbar interlaminar epidural injections in chronic axial or discogenic low back pain: results of 2-year follow-up. Pain Physician. 2013 Sep-Oct;16(5):E491-504.
PubMed 24077199Manchikanti L, Cash KA, McManus CD, Damron KS, Pampati V, Falco FJ. Lumbar interlaminar epidural injections in central spinal stenosis: preliminary results of a randomized, double-blind, active control trial. Pain Physician. 2012 Jan-Feb;15(1):51-63.
PubMed 22270738Manchikanti L, Cash KA, McManus CD, Pampati V, Benyamin RM. Preliminary results of a randomized, double-blind, controlled trial of fluoroscopic lumbar interlaminar epidural injections in managing chronic lumbar discogenic pain without disc herniation or radiculitis. Pain Physician. 2010 Jul-Aug;13(4):E279-92.
PubMed 20648214Manchikanti L, Singh V, Falco FJ, Cash KA, Pampati V. Evaluation of the effectiveness of lumbar interlaminar epidural injections in managing chronic pain of lumbar disc herniation or radiculitis: a randomized, double-blind, controlled trial. Pain Physician. 2010 Jul-Aug;13(4):343-55.
PubMed 20648203
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective, Double-Blind Controlled Evaluation of the Effectiveness of Lumbar Interlaminar Epidural Injections in Lumbar Disc Herniation, and Discogenic Pain
- ClinicalTrials.gov ID
- NCT00681447
- Acronym / sponsor ID
- protocol 15
- Conditions
- Low Back Pain
- Keywords
- lumbar disc herniation, discogenic pain, lumbar interlaminar epidural, injections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Pain Management Center of PaducahUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 21 May 2008 (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.
- To demonstrate clinically significant improvements in patients undergoing lumbar interlaminar epidurals. Improvement will be assessed in relation to the clinical outcome measures of pain and function.
- To evaluate and compare the adverse event profile in all patients.
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 |
|---|---|---|
| Group I | Other | Procedure: Lumbar Interlaminar Epidural, Procedure: Lumbar Interlaminar Epidural injectionLumbar interlaminar epidural injection with local anesthetic only |
| Group II | Other | Procedure: Lumbar Interlaminar Epidural, Procedure: Lumbar Interlaminar Epidural injectionLumbar Interlaminar Epidural Injection with local anesthetic wiht 6 mg of non-particulate Celestone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects of at least 18 years of age
- Subjects with a history of chronic, function-limiting chronic low back pain of at least 6 months in duration
- Subjects who are able to give voluntary, written informed consent to participate in this investigation
- Subjects who, in the opinion of the PI, are able to understand this investigation, co-operate with the investigational procedures, and are willing to return to the center for all the required post-operative follow-ups
- Subjects have not had recent surgical procedures within the last 3 months.
Key exclusion criteria (11 listed)
- Cauda Equina symptoms and/or compressive radiculopathy
- Narcotic use of no greater than hydrocodone 100 mg/day, methadone of 60 mg, or morphine 180 mg, or dose equivalent
- Uncontrolled major depression or uncontrolled psychiatric disorders
- Uncontrolled or acute medical illnesses including coagulopathy, renal insufficiency, chronic liver dysfunction, progressive neurological deficit, urinary sphincter dysfunction, infection, increased intracranial pressure, pseudotumor cerebri, intracranial tumors, unstable angina, and severe chronic obstructive pulmonary disease.
- Chronic severe conditions that could interfere with the interpretations of the outcome assessments for pain and bodily function
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 |
|---|---|---|
| Lumbar Interlaminar Epidural1. Lumbar interlaminar epidural injections under fluoroscopy 2. Epidural tray and needle 3. Drugs: 0.5% Xylocaine and non-particulate Celestone | Procedure or surgery | Group I, Group II |
| Lumbar Interlaminar Epidural injection1. Lumbar interlaminar epidural injections under fluoroscopy 2. Epidural tray and needle 3. Drugs: 0.5% Xylocaine and non-particulate Celestone | Procedure or surgery | Group I, Group II |
Primary outcome
To demonstrate clinically significant improvement or lack thereof with the lumbar interlaminar epidural patients with or without steroids.
Time frame: Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months.
2 secondary outcomes
To evaluate differences in outcomes in patients receiving steroids compared to those patients randomized to the local anesthetic group who did not receive steroids.
Time frame: Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months.
To evaluate and compare the adverse event profile in all patients.
Time frame: Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months.
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 21 Oct 2015.
- Derived from this study: PubMed 25675062Manchikanti L, Cash KA, McManus CD, Damron KS, Pampati V, Falco FJ. A randomized, double-blind controlled trial of lumbar interlaminar epidural injections in central spinal stenosis: 2-year follow-up. Pain Physician. 2015 Jan-Feb;18(1):79-92.
- Derived from this study: PubMed 24452658Manchikanti L, Singh V, Cash KA, Pampati V, Falco FJ. A randomized, double-blind, active-control trial of the effectiveness of lumbar interlaminar epidural injections in disc herniation. Pain Physician. 2014 Jan-Feb;17(1):E61-74.
- Derived from this study: PubMed 24077199Manchikanti L, Cash KA, McManus CD, Pampati V, Benyamin RM. A randomized, double-blind, active-controlled trial of fluoroscopic lumbar interlaminar epidural injections in chronic axial or discogenic low back pain: results of 2-year follow-up. Pain Physician. 2013 Sep-Oct;16(5):E491-504.
- Derived from this study: PubMed 22270738Manchikanti L, Cash KA, McManus CD, Damron KS, Pampati V, Falco FJ. Lumbar interlaminar epidural injections in central spinal stenosis: preliminary results of a randomized, double-blind, active control trial. Pain Physician. 2012 Jan-Feb;15(1):51-63.
- Derived from this study: PubMed 20648214Manchikanti L, Cash KA, McManus CD, Pampati V, Benyamin RM. Preliminary results of a randomized, double-blind, controlled trial of fluoroscopic lumbar interlaminar epidural injections in managing chronic lumbar discogenic pain without disc herniation or radiculitis. Pain Physician. 2010 Jul-Aug;13(4):E279-92.
- Derived from this study: PubMed 20648203Manchikanti L, Singh V, Falco FJ, Cash KA, Pampati V. Evaluation of the effectiveness of lumbar interlaminar epidural injections in managing chronic pain of lumbar disc herniation or radiculitis: a randomized, double-blind, controlled trial. Pain Physician. 2010 Jul-Aug;13(4):343-55.
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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.
Laxmaiah Manchikanti, MD principal investigator
Ambulatory Surgery Center, Paducah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar Interlaminar Epidural and Lumbar Interlaminar Epidural injection in people with Low Back Pain, run by Pain Management Center of Paducah 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 5 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 21 Oct 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?
To demonstrate clinically significant improvement or lack thereof with the lumbar interlaminar epidural patients with or without steroids. (time frame: Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months.). 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 NCT00681447, 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 21 Oct 2015.