Low Back PainNCT01052571
Evaluation of the Effectiveness of Transforaminal Epidural Injections in Lumbar Disc Herniation or Radiculitis
A study testing lumbar transforaminal epidural injections in people with Low Back Pain, run by Pain Management Center of Paducah at 1 site in United States.
Trial summary
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 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 transforaminal epidural injections
- 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 2010to Aug 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
- Patients with disc herniation or radiculitis
- Patients who are 18 years of age
- Patients with a history of chronic function-limiting low back and lower extremity pain of at least 6 months duration
- Patients who are competent to understand the study protocol and provide voluntary, written informed consent and participate in outcome measurements
Who cannot join
- Previous lumbar surgery, radiculitis secondary to spinal stenosis without disc herniation
- Uncontrollable or unstable opioid use
- Uncontrolled psychiatric disorders
- Uncontrolled medical illness either acute or chronic
- Any conditions that could interfere with the interpretation of the outcome assessments
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Prospective, Double-Blind, Equivalence, Controlled Evaluation of the Effectiveness of Transforaminal Epidural Injections in Lumbar Disc Herniation or Radiculitis With or 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 evaluate and compare the adverse event profile in all patients.
Read the detailed description
Recruitment is indicated in patients with chronic low back and lower extremity pain secondary to lumbar disc herniation and/or lumbar radiculitis of at least 6-months duration, non-responsive to conservative management with NSAIDs, physical therapy, chiropractic treatment, and exercises.
This is a single center study performed in an interventional pain management referral center in the United States.
The study involves 120 patients studied in 2 groups with 60 patients in each group. Randomization includes sequence generation, allocation concealment, implementation, and blinding.
Data management analysis includes sample size justification of 40 patients in each group with a power of 80% and a 0.05% 2-sided significance level. Statistical methodology includes chi-squared statistics, Fisher's exact test, t-test, and paired t-test with significance evaluated at P value < 0.05.
- Conditions
- Low Back Pain
- Being tested
- lumbar transforaminal epidural injections
- Keywords
- Chronic low back pain, Lumbar disc herniation, Lower extremity pain, Lumbar radiculitis, Local anesthetic, Steroid, Lumbar transforaminal epidural injection
- Medical subject headings
- Low Back Pain, Intervertebral Disc Displacement, Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lumbar transforaminal epidural injectionsProcedure or surgery
Also called Transforaminal Epidural
with an injection of local anesthetic or with 1% lidocaine or 0.25% bupivacaine with 3 mg of steroid per level
| Study group | Role | What they receive |
|---|---|---|
| Without Steroids | Active comparator | Group I patients receiving lumbar transforaminal epidural injections with an injection of local anesthetic (lidocaine 1% or bupivacaine 0.25% Receives: Procedure: lumbar transforaminal epidural injections |
| steroids | Active comparator | Group II patients will receive lumbar transforaminal epidural injections with 1% lidocaine or 0.25% bupivacaine with 3 mg of steroid per level Receives: Procedure: lumbar transforaminal epidural injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric rating scale (NRS), Oswestry Disability Index (ODI), duration of significant pain relief, opioid intake, and return to work
Measured: Outcomes are measured at baseline and at 3, 6, 12, 18, and 24 months post-treatment.
Secondary outcomes (1)
Adverse event profile of side effects and complications.
Measured: Adverse events are measured at baseline and at 3, 6, 12, 18, and 24 months post-treatment, and at any time during the procedure or after the procedure the adverse events are suspected or expected.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2010 (estimated)
- Study startFeb 2010
- Primary completionJan 2012
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Care provider
- 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
- NCT01052571
- Sponsor's protocol ID
- Protocol 24
- Status last verified
- Oct 2015
- First submitted
- 18 Jan 2010
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
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, Equivalence, Controlled Evaluation of the Effectiveness of Transforaminal Epidural Injections in Lumbar Disc Herniation or Radiculitis With or Without Steroids
- ClinicalTrials.gov ID
- NCT01052571
- Acronym / sponsor ID
- Protocol 24
- Conditions
- Low Back Pain
- Keywords
- Chronic low back pain, Lumbar disc herniation, Lower extremity pain, Lumbar radiculitis, Local anesthetic, Steroid, Lumbar transforaminal epidural injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Pain Management Center of PaducahUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 20 Jan 2010 (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 evaluate differences in outcomes in patients receiving steroids compared to those patients randomized to the local anesthetic group who did not receive steroids.
To evaluate and compare the adverse event profile in all patients.
Detailed description
Recruitment is indicated in patients with chronic low back and lower extremity pain secondary to lumbar disc herniation and/or lumbar radiculitis of at least 6-months duration, non-responsive to conservative management with NSAIDs, physical therapy, chiropractic treatment, and exercises.
This is a single center study performed in an interventional pain management referral center in the United States.
The study involves 120 patients studied in 2 groups with 60 patients in each group. Randomization includes sequence generation, allocation concealment, implementation, and blinding.
Data management analysis includes sample size justification of 40 patients in each group with a power of 80% and a 0.05% 2-sided significance level. Statistical methodology includes chi-squared statistics, Fisher's exact test, t-test, and paired t-test with significance evaluated at P value < 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Without Steroids | Active comparator | Procedure: lumbar transforaminal epidural injectionsGroup I patients receiving lumbar transforaminal epidural injections with an injection of local anesthetic (lidocaine 1% or bupivacaine 0.25% |
| steroids | Active comparator | Procedure: lumbar transforaminal epidural injectionsGroup II patients will receive lumbar transforaminal epidural injections with 1% lidocaine or 0.25% bupivacaine with 3 mg of steroid per level |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with disc herniation or radiculitis
- Patients who are 18 years of age
- Patients with a history of chronic function-limiting low back and lower extremity pain of at least 6 months duration
- Patients who are competent to understand the study protocol and provide voluntary, written informed consent and participate in outcome measurements
Key exclusion criteria (6 listed)
- Previous lumbar surgery, radiculitis secondary to spinal stenosis without disc herniation
- Uncontrollable or unstable opioid use
- Uncontrolled psychiatric disorders
- Uncontrolled medical illness either acute or chronic
- Any conditions that could interfere with the interpretation of the 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 |
|---|---|---|
| lumbar transforaminal epidural injectionsAlso: Transforaminal Epiduralwith an injection of local anesthetic or with 1% lidocaine or 0.25% bupivacaine with 3 mg of steroid per level | Procedure or surgery | Without Steroids, steroids |
Primary outcome
Numeric rating scale (NRS), Oswestry Disability Index (ODI), duration of significant pain relief, opioid intake, and return to work
Time frame: Outcomes are measured at baseline and at 3, 6, 12, 18, and 24 months post-treatment.
1 secondary outcome
Adverse event profile of side effects and complications.
Time frame: Adverse events are measured at baseline and at 3, 6, 12, 18, and 24 months post-treatment, and at any time during the procedure or after the procedure the adverse events are suspected or expected.
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.
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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 transforaminal epidural injections 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 4 inclusion and 6 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?
Numeric rating scale (NRS), Oswestry Disability Index (ODI), duration of significant pain relief, opioid intake, and return to work (time frame: Outcomes are measured at baseline and at 3, 6, 12, 18, and 24 months post-treatment.). 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 21 Oct 2015.