Effectiveness of Percutaneous Lumbar Epidural Adhesiolysis and Neurolysis on Low Back Pain
A Randomized, Prospective, Double-blind Controlled Evaluation of the Effectiveness of Percutaneous Lumbar Epidural Adhesiolysis and Hypertonic Saline Neurolysis
1 other identifier
interventional
120
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable low-back-pain
Started Jan 2006
Longer than P75 for not_applicable low-back-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 30, 2006
CompletedFirst Posted
Study publicly available on registry
September 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedResults Posted
Study results publicly available
November 23, 2015
CompletedMarch 10, 2020
March 1, 2020
3.9 years
August 30, 2006
March 21, 2012
March 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Numeric Pain Rating Score
Numeric rating scale represented 0 with no pain and 10 with the worst pain imaginable
3, 6, 12, 18 and 24 months post treatment.
Secondary Outcomes (1)
Functional Status
3, 6, 12, 18 and 24 months post treatment.
Study Arms (2)
Caudal epidural injection
ACTIVE COMPARATORCaudal 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
Percutaneous adhesiolysis
ACTIVE COMPARATORPecutaneous 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
Interventions
Caudal epidural injection with catheterization
Percutaneous adhesiolysis with hypertonic saline neurolysis
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ambulatory Surgery Center
Paducah, Kentucky, 42003, United States
Related Publications (3)
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.
PMID: 23293536RESULTManchikanti 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.
PMID: 19935992DERIVEDManchikanti 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.
PMID: 19935991DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The results of this study are limited by potentially inadequate double blinding, by the lack of a placebo group.
Results Point of Contact
- Title
- Dr. Laxmaiah Manchikanti
- Organization
- Pain Management Center of Paducah
Study Officials
- PRINCIPAL INVESTIGATOR
Laxmaiah Manchikanti, MD
Ambulatory Surgery Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Director
Study Record Dates
First Submitted
August 30, 2006
First Posted
September 1, 2006
Study Start
January 1, 2006
Primary Completion
December 1, 2009
Study Completion
April 1, 2013
Last Updated
March 10, 2020
Results First Posted
November 23, 2015
Record last verified: 2020-03