A Randomized, Equivalence Trial of Percutaneous Lumbar Adhesiolysis and Caudal Epidural Steroid Injections
This study is enrolling participants by invitation only.
Sponsor:
Pain Management Center of Paducah
Information provided by (Responsible Party):
Laxmaiah Manchikanti, MD, Pain Management Center of Paducah
ClinicalTrials.gov Identifier:
NCT01053273
First received: January 19, 2010
Last updated: March 21, 2012
Last verified: March 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Low Back Pain |
Procedure: Caudal Epidural Injection Procedure: percutaneous adhesiolysis |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment |
| Official Title: | Comparative Effectiveness of Percutaneous Adhesiolysis and Caudal Epidural Steroid Injections in Low Back and/or Lower Extremity Pain: A Randomized, Equivalence Trial |
Resource links provided by NLM:
Further study details as provided by Pain Management Center of Paducah:
Primary Outcome Measures:
- 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. ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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. ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 120 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | January 2014 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Caudal epidural Injection
Group I will receive caudal epidural injections with catheterization up to S3 with local anesthetic, steroids, and 0.9% sodium chloride solution
|
Procedure: Caudal Epidural Injection
Group I will receive caudal epidural injections with catheterization up to S3 with local anesthetic, steroids, and 0.9% sodium chloride solution
|
|
Active Comparator: Percutaneous Adhesiolysis
Group II will receive percutaneous adhesiolysis with targeted delivery of lidocaine, 10% hypertonic sodium chloride solution, and non-particulate betamethasone
|
Procedure: percutaneous adhesiolysis
Group II will receive percutaneous adhesiolysis with targeted delivery of lidocaine, 10% hypertonic sodium chloride solution, and non-particulate betamethasone.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- 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
Exclusion criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01053273
Locations
| United States, Kentucky | |
| Pain Management Center of Paducah | |
| Paducah, Kentucky, United States, 42001 | |
Sponsors and Collaborators
Pain Management Center of Paducah
Investigators
| Principal Investigator: | Laxmaiah Manchikanti | Ambulatory Surgery Center, Paducah |
More Information
No publications provided by Pain Management Center of Paducah
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Laxmaiah Manchikanti, MD, Medical Director, Pain Management Center of Paducah |
| ClinicalTrials.gov Identifier: | NCT01053273 History of Changes |
| Other Study ID Numbers: | Protocol 27 |
| Study First Received: | January 19, 2010 |
| Last Updated: | March 21, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Pain Management Center of Paducah:
|
Low back pain Post lumbar laminectomy syndrome Lumbar spinal stenosis Local anesthetic steroid |
Lumbar transforaminal epidural injection Percutaneous epidural adhesiolysis Caudal epidural injection |
Additional relevant MeSH terms:
|
Back Pain Low Back Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Anesthetics, Local Anesthetics |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013