Low Back PainEarly Phase 1NCT00370799
Effectiveness of Caudal Epidural Injections in Treatment of Chronic Low Back and Lower Extremity Pain
A Early Phase 1 study testing Caudal epidural injection, Caudal Epidural Injection with generic Celestone and Caudal Epidural Injection with Celestone in people with Low Back Pain, run by Pain Management Center of Paducah at 1 site in United States.
Trial summary
To demonstrate clinically significant improvements or lack thereof in the caudal epidural patients with our without steroids. To evaluate differences in outcomes in patients receiving steroids compared to those patients randomized to the local anesthetic group who did not receive steroids. 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?
- Caudal epidural injection, Caudal Epidural Injection with generic Celestone and Caudal Epidural Injection with Celestone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Mar 2010
- Phase
- Early Phase 1
- 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
- At least 18 years of age
- History of chronic, function-limiting low back pain of at least 6 months duration
- Able to give voluntary, written informed consent to participate,
- Able to understand the investigation, cooperate with the procedures, and willing to return for follow-up
- No recent surgical procedures within last three months
Who cannot join
- Cauda Equina symptoms and/or compressive radiculopathy
- Narcotic use of no greater than 100mg/day hydrocodone, 60mg Methadone. or 100mg morphine
- Uncontrolled major Depression or uncontrolled psychiatric disorder
- Uncontrolled or acute medical illnesses
- Chronic severe conditions that could interfere with outcome assessments
- Women who are pregnant or lactating
Show all 10Show fewer
- 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
- Inability to achieve proper 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
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 Caudal Epidural Injections in Lumbar Disc Herniations, Spinal Stenosis, Discogenic Pain, and Post-Lumbar Laminectomy Syndrome
To demonstrate clinically significant improvements or lack thereof in the caudal epidural patients with our without steroids.
To evaluate differences in outcomes in patients receiving steroids compared to those patients randomized to the local anesthetic group who did not receive steroids.
To assess improvements among patients and compare steroid groups with each other and local anesthetic group.
To evaluate and compare the adverse event profile in all patients
Read the detailed description
Patients with chronic low back pain of at least 6 months duration, non-responsive to conservative management with NSAIDS, physical therapy or chiropractic treatment exercises.
A single-center, prospective, controlled, double blinded, randomized study of patients in 4 groups.
- Group 1. local anesthetics only
- Group 2. local anesthetic with 6mg of non-particulate Celestone
- Group 3. local anesthetic with 6 mg of brand name Celestone
- Group 4. local anesthetic with 40 mg of alcohol-free DepoMedrol
All patients will be unblinded in 12 months.
Non-responsive patients will be unblinded after 3 months and will be crossed over to a different group
- Conditions
- Low Back Pain
- Being tested
- Caudal epidural injection, Caudal Epidural Injection with generic Celestone, Caudal Epidural Injection with Celestone, Caudal Epidural Injection with DepoMedrol
- Keywords
- Caudal Epidural injections, lumbar disc herniation, spinal stenosis, discogenic pain, post-lumbar laminectomy syndrome
- Medical subject headings
- Low Back Pain, Intervertebral Disc Displacement, Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caudal epidural injectionDrug
Also called Group 1
group 1: Caudal epidural injection local anesthetics only
Caudal Epidural Injection with generic CelestoneDrug
Also called Group 2
Group 2. Caudal Epidural Injection local anesthetic with 6mg of non-particulate Celestone
Caudal Epidural Injection with CelestoneDrug
Also called Group 3
Group 3. Caudal Epidural Injection with local anesthetic with 6 mg of brand name Celestone
Caudal Epidural Injection with DepoMedrolDrug
Also called Group 4
Group 4. local anesthetic with 40 mg of alcohol-free DepoMedrol
| Study group | Role | What they receive |
|---|---|---|
| local anesthetic | Active comparator | Group 1. local anesthetics only Receives: Drug: Caudal epidural injection |
| Local anesthetic with generic Celestone | Active comparator | Group 2. local anesthetic with 6mg of non-particulate Celestone Receives: Drug: Caudal Epidural Injection with generic Celestone |
| Local anesthetic with Celestone | Active comparator | Group 3. local anesthetic with 6 mg of brand nameCelestone Receives: Drug: Caudal Epidural Injection with Celestone |
| Local anesthetic with DepoMedrol | Active comparator | Group 4. local anesthetic with 40 mg of alcohol-free DepoMedrol Receives: Drug: Caudal Epidural Injection with DepoMedrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate for differences between the patients in various groups in the physical function and pain at 1, 3, 6, and 12 months post treatment
Measured: 1,3,6,12 months
Secondary outcomes (1)
To assess adverse events in all four groups.
Measured: 1,3,6,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2006 (estimated)
- Study startJan 2007
- Primary completionDec 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 240 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00370799
- Sponsor's protocol ID
- protocol 10
- Status last verified
- Aug 2013
- First submitted
- 30 Aug 2006
- Last updated
- 16 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Manchikanti L, Singh V, Cash KA, Pampati V, Damron KS, Boswell MV. Effect of fluoroscopically guided caudal epidural steroid or local anesthetic injections in the treatment of lumbar disc herniation and radiculitis: a randomized, controlled, double blind trial with a two-year follow-up. Pain Physician. 2012 Jul-Aug;15(4):273-86.
PubMed 22828681Manchikanti L, Cash KA, McManus CD, Pampati V, Smith HS. One-year results of a randomized, double-blind, active controlled trial of fluoroscopic caudal epidural injections with or without steroids in managing chronic discogenic low back pain without disc herniation or radiculitis. Pain Physician. 2011 Jan-Feb;14(1):25-36.
PubMed 21267039Manchikanti L, Singh V, Cash KA, Pampati V, Datta S. Management of pain of post lumbar surgery syndrome: one-year results of a randomized, double-blind, active controlled trial of fluoroscopic caudal epidural injections. Pain Physician. 2010 Nov-Dec;13(6):509-21.
PubMed 21102963
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2013. 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 Caudal Epidural Injections in Lumbar Disc Herniations, Spinal Stenosis, Discogenic Pain, and Post-Lumbar Laminectomy Syndrome
- ClinicalTrials.gov ID
- NCT00370799
- Acronym / sponsor ID
- protocol 10
- Conditions
- Low Back Pain
- Keywords
- Caudal Epidural injections, lumbar disc herniation, spinal stenosis, discogenic pain, post-lumbar laminectomy syndrome
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Pain Management Center of PaducahUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 1 Sep 2006 (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 or lack thereof in the caudal epidural patients with our without steroids.
To evaluate differences in outcomes in patients receiving steroids compared to those patients randomized to the local anesthetic group who did not receive steroids.
To assess improvements among patients and compare steroid groups with each other and local anesthetic group.
To evaluate and compare the adverse event profile in all patients
Detailed description
Patients with chronic low back pain of at least 6 months duration, non-responsive to conservative management with NSAIDS, physical therapy or chiropractic treatment exercises.
A single-center, prospective, controlled, double blinded, randomized study of patients in 4 groups.
- Group 1. local anesthetics only
- Group 2. local anesthetic with 6mg of non-particulate Celestone
- Group 3. local anesthetic with 6 mg of brand name Celestone
- Group 4. local anesthetic with 40 mg of alcohol-free DepoMedrol
All patients will be unblinded in 12 months.
Non-responsive patients will be unblinded after 3 months and will be crossed over to a different group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| local anesthetic | Active comparator | Drug: Caudal epidural injectionGroup 1. local anesthetics only |
| Local anesthetic with generic Celestone | Active comparator | Drug: Caudal Epidural Injection with generic CelestoneGroup 2. local anesthetic with 6mg of non-particulate Celestone |
| Local anesthetic with Celestone | Active comparator | Drug: Caudal Epidural Injection with CelestoneGroup 3. local anesthetic with 6 mg of brand nameCelestone |
| Local anesthetic with DepoMedrol | Active comparator | Drug: Caudal Epidural Injection with DepoMedrolGroup 4. local anesthetic with 40 mg of alcohol-free DepoMedrol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years of age
- History of chronic, function-limiting low back pain of at least 6 months duration
- Able to give voluntary, written informed consent to participate,
- Able to understand the investigation, cooperate with the procedures, and willing to return for follow-up
- No recent surgical procedures within last three months
Key exclusion criteria (10 listed)
- Cauda Equina symptoms and/or compressive radiculopathy
- Narcotic use of no greater than 100mg/day hydrocodone, 60mg Methadone. or 100mg morphine
- Uncontrolled major Depression or uncontrolled psychiatric disorder
- Uncontrolled or acute medical illnesses
- Chronic severe conditions that could interfere with outcome assessments
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 |
|---|---|---|
| Caudal epidural injectionAlso: Group 1group 1: Caudal epidural injection local anesthetics only | Drug | local anesthetic |
| Caudal Epidural Injection with generic CelestoneAlso: Group 2Group 2. Caudal Epidural Injection local anesthetic with 6mg of non-particulate Celestone | Drug | Local anesthetic with generic Celestone |
| Caudal Epidural Injection with CelestoneAlso: Group 3Group 3. Caudal Epidural Injection with local anesthetic with 6 mg of brand name Celestone | Drug | Local anesthetic with Celestone |
| Caudal Epidural Injection with DepoMedrolAlso: Group 4Group 4. local anesthetic with 40 mg of alcohol-free DepoMedrol | Drug | Local anesthetic with DepoMedrol |
Primary outcome
To evaluate for differences between the patients in various groups in the physical function and pain at 1, 3, 6, and 12 months post treatment
Time frame: 1,3,6,12 months
1 secondary outcome
To assess adverse events in all four groups.
Time frame: 1,3,6,12 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 16 Aug 2013.
- Derived from this study: PubMed 22828681Manchikanti L, Singh V, Cash KA, Pampati V, Damron KS, Boswell MV. Effect of fluoroscopically guided caudal epidural steroid or local anesthetic injections in the treatment of lumbar disc herniation and radiculitis: a randomized, controlled, double blind trial with a two-year follow-up. Pain Physician. 2012 Jul-Aug;15(4):273-86.
- Derived from this study: PubMed 21267039Manchikanti L, Cash KA, McManus CD, Pampati V, Smith HS. One-year results of a randomized, double-blind, active controlled trial of fluoroscopic caudal epidural injections with or without steroids in managing chronic discogenic low back pain without disc herniation or radiculitis. Pain Physician. 2011 Jan-Feb;14(1):25-36.
- Derived from this study: PubMed 21102963Manchikanti L, Singh V, Cash KA, Pampati V, Datta S. Management of pain of post lumbar surgery syndrome: one-year results of a randomized, double-blind, active controlled trial of fluoroscopic caudal epidural injections. Pain Physician. 2010 Nov-Dec;13(6):509-21.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Caudal epidural injection, Caudal Epidural Injection with generic Celestone and Caudal Epidural Injection with Celestone 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 10 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 16 Aug 2013. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 evaluate for differences between the patients in various groups in the physical function and pain at 1, 3, 6, and 12 months post treatment (time frame: 1,3,6,12 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 NCT00370799, which also lists 3 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 16 Aug 2013.