NCT01053572

Brief Summary

To evaluate the effectiveness of steroids and/or 10% hypertonic sodium chloride in percutaneous adhesiolysis in managing chronic low back and/or lower extremity pain in patients with post lumbar surgery syndrome. To 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
240

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

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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 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 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

Chronic low back painPost lumbar laminectomy syndromeLower extremity painLocal anestheticSteroidPercutaneous lumbar adhesiolysis

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 (4)

Celestone

ACTIVE COMPARATOR

Group I will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and non-particulate Celestone

Procedure: Adhesiolysis

sodium chloride solution

ACTIVE COMPARATOR

Group II will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and 0.9% sodium chloride solution to substitute for non-particulate Celestone

Procedure: Adhesiolysis

sodium choride solution

ACTIVE COMPARATOR

Group III will receive adhesiolysis, local anesthetic, normal sodium chloride solution instead of 10% hypertonic sodium chloride solution and non-particulate Celestone;

Procedure: Adhesiolysis

Double substitutes

ACTIVE COMPARATOR

Group IV will receive adhesiolysis, local anesthetic, and 0.9% sodium chloride solution to substitute for the 10% hypertonic sodium chloride, and 0.9% sodium chloride solution to substitute for non-particulate Celestone

Procedure: Adhesiolysis

Interventions

AdhesiolysisPROCEDURE

Group I will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and non-particulate Celestone

Also known as: Adhesiolysis in post-surgery
CelestoneDouble substitutessodium chloride solutionsodium choride solution

Eligibility Criteria

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

You may qualify if:

  • History of lumbar surgery of at least 6 months duration in the past
  • Patients over the age of 18 years
  • Patients with a history of chronic function-limiting low back pain with or without lower extremity pain of at least 6 months duration (post-surgery)
  • 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:

  • Facet joints, uncontrollable as sole pain generators
  • Unstable or heavy opioid use (400 mg of morphine equivalents daily)
  • 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 anesthetic, steroids, or hypertonic sodium chloride solution.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pain Management Center of Paducah

Paducah, Kentucky, 42001, United States

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Postoperative Period

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Perioperative PeriodSurgical Procedures, OperativePatient CareHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Laxmaiah Manchikanti, MD

    PMC of 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 1, 2014

Last Updated

April 25, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)