NCT01053273

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Feb 2010

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 19, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 21, 2010

Completed
11 days until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2014

Completed
Last Updated

April 25, 2017

Status Verified

April 1, 2017

Enrollment Period

1.9 years

First QC Date

January 19, 2010

Last Update Submit

April 24, 2017

Conditions

Low Back Pain

Keywords

Low back painPost lumbar laminectomy syndromeLumbar spinal stenosisLocal anesthetic steroidLumbar transforaminal epidural injectionPercutaneous epidural adhesiolysisCaudal epidural injection

Outcome Measures

Primary Outcomes (1)

  • Numeric rating scale (NRS), Oswestry Disability Index (ODI)

    duration of significant pain relief, opioid intake, and return to work

    Outcomes are measured at baseline and at 3, 6, 12, 18, and 24 months post-treatment.

Secondary Outcomes (1)

  • Adverse event profile of side effects and complications.

    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.

Study Arms (2)

Caudal epidural Injection

ACTIVE COMPARATOR

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

Percutaneous Adhesiolysis

ACTIVE COMPARATOR

Group II will receive percutaneous adhesiolysis with targeted delivery of lidocaine, 10% hypertonic sodium chloride solution, and non-particulate betamethasone

Procedure: percutaneous adhesiolysis

Interventions

Caudal Epidural InjectionPROCEDURE

Group I will receive caudal epidural injections with catheterization up to S3 with local anesthetic, steroids, and 0.9% sodium chloride solution

Caudal epidural Injection
percutaneous adhesiolysisPROCEDURE

Group II will receive percutaneous adhesiolysis with targeted delivery of lidocaine, 10% hypertonic sodium chloride solution, and non-particulate betamethasone.

Percutaneous Adhesiolysis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pain Management Center of Paducah

Paducah, Kentucky, 42001, United States

Location

Related Publications (1)

  • 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.

    PMID: 20309389DERIVED

MeSH Terms

Conditions

Low Back PainSpinal Stenosis

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Laxmaiah Manchikanti

    Ambulatory Surgery Center, Paducah

    PRINCIPAL INVESTIGATOR

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

January 19, 2010

First Posted

January 21, 2010

Study Start

February 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 27, 2014

Last Updated

April 25, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)