Low Back PainNCT01053273
A Randomized, Equivalence Trial of Percutaneous Lumbar Adhesiolysis and Caudal Epidural Steroid Injections
A study testing Caudal Epidural Injection and percutaneous adhesiolysis in people with Low Back Pain, run by Pain Management Center of Paducah at 1 site in United States.
Trial summary
The purpose of this study is to: evaluate the effectiveness of percutaneous epidural adhesiolysis in managing chronic low back and/or lower extremity pain in patients without post lumbar surgery syndrome or spinal stenosis and compare with fluoroscopically directed caudal epidural steroid injections. 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 and percutaneous adhesiolysis
- 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 27 Jan 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 history of lumbar surgery of at least 6 months duration in the past
- Patients over the 18 years of age
- Patients with a history of chronic function-limiting low back pain with or without 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
- Post surgery, central spinal stenosis, and facet joints as sole pain generators
- Unstable or heavy opioid use
- Uncontrolled psychiatric disorders
- Uncontrolled medical illness
- Any conditions that could interfere with the interpretation of the outcome assessments
- Pregnant or lactating women
- Patients with a history or potential for adverse reaction(s) to local anesthetics or steroid.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pain Management Center of Paducah
Paducah, Kentucky, 42001
About this study
Official title: Comparative Effectiveness of Percutaneous Adhesiolysis and Caudal Epidural Steroid Injections in Low Back and/or Lower Extremity Pain: A Randomized, Equivalence Trial
The purpose of this study is to:
- evaluate the effectiveness of percutaneous epidural adhesiolysis in managing chronic low back and/or lower extremity pain in patients without post lumbar surgery syndrome or spinal stenosis and compare with fluoroscopically directed caudal epidural steroid injections.
- evaluate and compare the adverse event profile in all groups.
Read the detailed description
Recruitment is indicated in patients with chronic low back pain and/or lower extremity pain without post lumbar laminectomy syndrome or spinal stenosis, non-responsive to conservative therapy with physical therapy, chiropractic, medical therapy, and fluoroscopically directed epidural injections.
This is a single-center study performed in an interventional pain management referral center in the United States.
The study involves 120 patients assigned to one of 2 groups with 60 patients in each group.
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
- Caudal Epidural Injection, percutaneous adhesiolysis
- Keywords
- Low back pain, Post lumbar laminectomy syndrome, Lumbar spinal stenosis, Local anesthetic steroid, Lumbar transforaminal epidural injection, Percutaneous epidural adhesiolysis, Caudal epidural injection
- Medical subject headings
- Low Back Pain, Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caudal Epidural InjectionProcedure or surgery
Group I will receive caudal epidural injections with catheterization up to S3 with local anesthetic, steroids, and 0.9% sodium chloride solution
percutaneous adhesiolysisProcedure or surgery
Group II will receive percutaneous adhesiolysis with targeted delivery of lidocaine, 10% hypertonic sodium chloride solution, and non-particulate betamethasone.
| Study group | Role | What they receive |
|---|---|---|
| Caudal epidural Injection | Active comparator | Group I will receive caudal epidural injections with catheterization up to S3 with local anesthetic, steroids, and 0.9% sodium chloride solution Receives: Procedure: Caudal Epidural Injection |
| Percutaneous Adhesiolysis | Active comparator | Group II will receive percutaneous adhesiolysis with targeted delivery of lidocaine, 10% hypertonic sodium chloride solution, and non-particulate betamethasone Receives: Procedure: percutaneous adhesiolysis |
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.
List and look at all 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 posted21 Jan 2010 (estimated)
- Study startFeb 2010
- Primary completionJan 2012
- Study completion27 Jan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 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, Principal investigator, Ambulatory Surgery Center, Paducah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01053273
- Sponsor's protocol ID
- Protocol 27
- Status last verified
- Apr 2017
- First submitted
- 19 Jan 2010
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Manchikanti L, Pampati V, Cash KA. Protocol for evaluation of the comparative effectiveness of percutaneous adhesiolysis and caudal epidural steroid injections in low back and/or lower extremity pain without post surgery syndrome or spinal stenosis. Pain Physician. 2010 Mar-Apr;13(2):E91-E110.
PubMed 20309389
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Percutaneous Adhesiolysis and Caudal Epidural Steroid Injections in Low Back and/or Lower Extremity Pain: A Randomized, Equivalence Trial
- ClinicalTrials.gov ID
- NCT01053273
- Acronym / sponsor ID
- Protocol 27
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Post lumbar laminectomy syndrome, Lumbar spinal stenosis, Local anesthetic steroid, Lumbar transforaminal epidural injection, Percutaneous epidural adhesiolysis, Caudal 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 (actual)
- Primary completion
- Jan 2012 (actual)
- Study completion
- 27 Jan 2014 (actual)
- First posted
- 21 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.
The purpose of this study is to:
- evaluate the effectiveness of percutaneous epidural adhesiolysis in managing chronic low back and/or lower extremity pain in patients without post lumbar surgery syndrome or spinal stenosis and compare with fluoroscopically directed caudal epidural steroid injections.
- evaluate and compare the adverse event profile in all groups.
Detailed description
Recruitment is indicated in patients with chronic low back pain and/or lower extremity pain without post lumbar laminectomy syndrome or spinal stenosis, non-responsive to conservative therapy with physical therapy, chiropractic, medical therapy, and fluoroscopically directed epidural injections.
This is a single-center study performed in an interventional pain management referral center in the United States.
The study involves 120 patients assigned to one of 2 groups with 60 patients in each group.
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 |
|---|---|---|
| Caudal epidural Injection | Active comparator | Procedure: Caudal Epidural InjectionGroup I will receive caudal epidural injections with catheterization up to S3 with local anesthetic, steroids, and 0.9% sodium chloride solution |
| Percutaneous Adhesiolysis | Active comparator | Procedure: percutaneous adhesiolysisGroup II will receive percutaneous adhesiolysis with targeted delivery of lidocaine, 10% hypertonic sodium chloride solution, and non-particulate betamethasone |
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 history of lumbar surgery of at least 6 months duration in the past
- Patients over the 18 years of age
- Patients with a history of chronic function-limiting low back pain with or without 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 (7 listed)
- Post surgery, central spinal stenosis, and facet joints as sole pain generators
- Unstable or heavy opioid use
- Uncontrolled psychiatric disorders
- Uncontrolled medical illness
- 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 |
|---|---|---|
| Caudal Epidural InjectionGroup I will receive caudal epidural injections with catheterization up to S3 with local anesthetic, steroids, and 0.9% sodium chloride solution | Procedure or surgery | Caudal epidural Injection |
| percutaneous adhesiolysisGroup II will receive percutaneous adhesiolysis with targeted delivery of lidocaine, 10% hypertonic sodium chloride solution, and non-particulate betamethasone. | Procedure or surgery | Percutaneous Adhesiolysis |
Primary outcome
Numeric rating scale (NRS), Oswestry Disability Index (ODI)
Time frame: Outcomes are measured at baseline and at 3, 6, 12, 18, and 24 months post-treatment.
duration of significant pain relief, opioid intake, and return to work
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 25 Apr 2017.
- Derived from this study: PubMed 20309389Manchikanti L, Pampati V, Cash KA. Protocol for evaluation of the comparative effectiveness of percutaneous adhesiolysis and caudal epidural steroid injections in low back and/or lower extremity pain without post surgery syndrome or spinal stenosis. Pain Physician. 2010 Mar-Apr;13(2):E91-E110.
- 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.
Laxmaiah Manchikanti 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 Caudal Epidural Injection and percutaneous adhesiolysis 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 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 25 Apr 2017. 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) (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?
On the ClinicalTrials.gov record for NCT01053273, which also lists 1 linked publication.
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 25 Apr 2017.