N/A N=120 Randomized Double-blind Treatment

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

Low Back Pain

Bottom Line

View on ClinicalTrials.gov: NCT00370994 ↗

Enrolled (actual)

120

Serious AEs

0.0%

Results posted

Nov 2015

Primary outcome: Primary: Numeric Pain Rating Score — 7.9; 8.1; 4.9; 3.4 units on a scale — p=<0.001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Caudal epidural injection (Procedure); Percutaneous adhesiolysis (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pain Management Center of Paducah
Primary completion: Dec 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Numeric Pain Rating Score	7.9; 8.1; 4.9; 3.4; 5.8; 3.7	<0.001 sig
SECONDARY Functional Status	28.6; 31.2; 20.2; 15.2; 22.3; 15.2	0.001 sig

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

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

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Data sourced from ClinicalTrials.gov (NCT00370994). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.