Back to resultsA Randomized, Equivalence Trial of Percutaneous Lumbar Adhesiolysis and Caudal Epidural Steroid Injections
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Caudal Epidural Injection
percutaneous adhesiolysis
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Low back pain, Post lumbar laminectomy syndrome, Lumbar spinal stenosis, Local anesthetic steroid, Lumbar transforaminal epidural injection, Percutaneous epidural adhesiolysis, Caudal epidural injection
Eligibility 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.
Sites / Locations
- Pain Management Center of Paducah
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Caudal epidural Injection
Percutaneous Adhesiolysis
Arm Description
Group I will receive caudal epidural injections with catheterization up to S3 with local anesthetic, steroids, and 0.9% sodium chloride solution
Group II will receive percutaneous adhesiolysis with targeted delivery of lidocaine, 10% hypertonic sodium chloride solution, and non-particulate betamethasone
Outcomes
Primary Outcome Measures
Numeric rating scale (NRS), Oswestry Disability Index (ODI)
duration of significant pain relief, opioid intake, and return to work
Secondary Outcome Measures
Adverse event profile of side effects and complications.
List and look at all side effects and complications
Full Information
NCT ID
NCT01053273
First Posted
January 19, 2010
Last Updated
April 24, 2017
Sponsor
Pain Management Center of Paducah
1. Study Identification
Unique Protocol Identification Number
NCT01053273
Brief Title
A Randomized, Equivalence Trial of Percutaneous Lumbar Adhesiolysis and Caudal Epidural Steroid Injections
Official Title
Comparative Effectiveness of Percutaneous Adhesiolysis and Caudal Epidural Steroid Injections in Low Back and/or Lower Extremity Pain: A Randomized, Equivalence Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
February 2010 (Actual)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 27, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pain Management Center of Paducah
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Caudal epidural Injection
Arm Type
Active Comparator
Arm Description
Group I will receive caudal epidural injections with catheterization up to S3 with local anesthetic, steroids, and 0.9% sodium chloride solution
Arm Title
Percutaneous Adhesiolysis
Arm Type
Active Comparator
Arm Description
Group II will receive percutaneous adhesiolysis with targeted delivery of lidocaine, 10% hypertonic sodium chloride solution, and non-particulate betamethasone
Intervention Type
Procedure
Intervention Name(s)
Caudal Epidural Injection
Intervention Description
Group I will receive caudal epidural injections with catheterization up to S3 with local anesthetic, steroids, and 0.9% sodium chloride solution
Intervention Type
Procedure
Intervention Name(s)
percutaneous adhesiolysis
Intervention Description
Group II will receive percutaneous adhesiolysis with targeted delivery of lidocaine, 10% hypertonic sodium chloride solution, and non-particulate betamethasone.
Primary Outcome Measure Information:
Title
Numeric rating scale (NRS), Oswestry Disability Index (ODI)
Description
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.
Secondary Outcome Measure Information:
Title
Adverse event profile of side effects and complications.
Description
List and look at all 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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laxmaiah Manchikanti
Organizational Affiliation
Ambulatory Surgery Center, Paducah
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pain Management Center of Paducah
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42001
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20309389
Citation
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.
Results Reference
derived
Learn more about this trial
A Randomized, Equivalence Trial of Percutaneous Lumbar Adhesiolysis and Caudal Epidural Steroid Injections
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