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Effectiveness of Percutaneous Lumbar Epidural Adhesiolysis and Neurolysis on Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Caudal epidural injection
Percutaneous adhesiolysis
Sponsored by
Pain Management Center of Paducah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring post-lumbar surgery syndrome, percutaneous lumbar epidural adhesiolysis, hypertonic saline neurolysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Over 18 years of age History of chronic, function limiting low back pain of at least 6 months in duration Able to give voluntary, written informed consent Able to understand investigational procedures and willing to return for follow-ups No recent surgical procedures within last 3 months Exclusion Criteria: Large contained or sequestered herniation 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 psychiatric disorder Uncontrolled or acute medical illness Chronic sever conditions that could interfere with outcome assessments Women who are pregnant or lactating Subjects who have participated in a clinical study with an investigational product within 30 days of enrollment

Sites / Locations

  • Ambulatory Surgery Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Caudal epidural injection

Percutaneous adhesiolysis

Arm Description

Caudal epidural with placement of catheter in sacral canal with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 0.9% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution

Pecutaneous adhesiolysis and targeted placement of Racz catheter with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 10% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution

Outcomes

Primary Outcome Measures

Numeric Pain Rating Score
Numeric rating scale represented 0 with no pain and 10 with the worst pain imaginable

Secondary Outcome Measures

Functional Status
Oswestry Disability Index (ODI) - ODI score is ranged from 0 to 50. Total score is converted in to percent disability. ODI Scoring: 0% to 20% (minimal disability), 21%-40% (moderate disability), 41%-60% (severe disability), 61%-80% (crippled) and 81%-100 These patients are either bed-bound or exaggerating their symptoms.

Full Information

First Posted
August 30, 2006
Last Updated
March 2, 2020
Sponsor
Pain Management Center of Paducah
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1. Study Identification

Unique Protocol Identification Number
NCT00370994
Brief Title
Effectiveness of Percutaneous Lumbar Epidural Adhesiolysis and Neurolysis on Low Back Pain
Official Title
A Randomized, Prospective, Double-blind Controlled Evaluation of the Effectiveness of Percutaneous Lumbar Epidural Adhesiolysis and Hypertonic Saline Neurolysis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pain Management Center of Paducah

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Clinically significant improvements in the percutaneous adhesiolysis patients with hypertonic neurolysis compared to those patients randomized to the control group who did not receive adhesiolysis and hypertonic saline neurolysis. Improvement will be assessed in relation to the clinical outcome measures of pain and function. Improvements among patients with adhesiolysis and hypertonic saline neurolysis and compare to control group. Compare adverse event profile in both groups
Detailed Description
Patients with chronic low back pain and lower extremity pain secondary to spinal stenosis or post lumbar laminectomy syndrome, non responsive to conservative therapy with physical therapy or chiropractic and medical therapy and fluoroscopically directed epidural steroid injections. Single-center, prospective, controlled, double blind, randomized study. If non-responsive or at patient's request, the patient may be unblinded anytime after 3 months, and will be offered adhesiolysis and hypertonic saline neurolysis if the patient was in the control group. All patients will be unblinded at 24 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
post-lumbar surgery syndrome, percutaneous lumbar epidural adhesiolysis, hypertonic saline neurolysis

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
Caudal epidural with placement of catheter in sacral canal with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 0.9% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
Arm Title
Percutaneous adhesiolysis
Arm Type
Active Comparator
Arm Description
Pecutaneous adhesiolysis and targeted placement of Racz catheter with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 10% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
Intervention Type
Procedure
Intervention Name(s)
Caudal epidural injection
Intervention Description
Caudal epidural injection with catheterization
Intervention Type
Procedure
Intervention Name(s)
Percutaneous adhesiolysis
Intervention Description
Percutaneous adhesiolysis with hypertonic saline neurolysis
Primary Outcome Measure Information:
Title
Numeric Pain Rating Score
Description
Numeric rating scale represented 0 with no pain and 10 with the worst pain imaginable
Time Frame
3, 6, 12, 18 and 24 months post treatment.
Secondary Outcome Measure Information:
Title
Functional Status
Description
Oswestry Disability Index (ODI) - ODI score is ranged from 0 to 50. Total score is converted in to percent disability. ODI Scoring: 0% to 20% (minimal disability), 21%-40% (moderate disability), 41%-60% (severe disability), 61%-80% (crippled) and 81%-100 These patients are either bed-bound or exaggerating their symptoms.
Time Frame
3, 6, 12, 18 and 24 months post treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Over 18 years of age History of chronic, function limiting low back pain of at least 6 months in duration Able to give voluntary, written informed consent Able to understand investigational procedures and willing to return for follow-ups No recent surgical procedures within last 3 months Exclusion Criteria: Large contained or sequestered herniation 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 psychiatric disorder Uncontrolled or acute medical illness Chronic sever conditions that could interfere with outcome assessments Women who are pregnant or lactating Subjects who have participated in a clinical study with an investigational product within 30 days of enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laxmaiah Manchikanti, MD
Organizational Affiliation
Ambulatory Surgery Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ambulatory Surgery Center
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23293536
Citation
Manchikanti L, Singh V, Cash KA, Pampati V. Assessment of effectiveness of percutaneous adhesiolysis and caudal epidural injections in managing post lumbar surgery syndrome: 2-year follow-up of a randomized, controlled trial. J Pain Res. 2012;5:597-608. doi: 10.2147/JPR.S38999. Epub 2012 Dec 20.
Results Reference
result
PubMed Identifier
19935992
Citation
Manchikanti L, Singh V, Cash KA, Pampati V, Datta S. A comparative effectiveness evaluation of percutaneous adhesiolysis and epidural steroid injections in managing lumbar post surgery syndrome: a randomized, equivalence controlled trial. Pain Physician. 2009 Nov-Dec;12(6):E355-68.
Results Reference
derived
PubMed Identifier
19935991
Citation
Manchikanti L, Cash KA, McManus CD, Pampati V, Singh V, Benyamin R. The preliminary results of a comparative effectiveness evaluation of adhesiolysis and caudal epidural injections in managing chronic low back pain secondary to spinal stenosis: a randomized, equivalence controlled trial. Pain Physician. 2009 Nov-Dec;12(6):E341-54.
Results Reference
derived
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3533727/
Description
Assessment of effectiveness of percutaneous adhesiolysis and caudal epidural injections in managing post lumbar surgery syndrome: 2-year follow-up of a randomized, controlled trial.

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Effectiveness of Percutaneous Lumbar Epidural Adhesiolysis and Neurolysis on Low Back Pain

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