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Role of Steroids and 10% Hypertonic Sodium Chloride in Adhesiolysis in Post Lumbar Surgery Syndrome Patients

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
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 Chronic low back pain, Post lumbar laminectomy syndrome, Lower extremity pain, Local anesthetic, Steroid, Percutaneous lumbar adhesiolysis

Eligibility Criteria

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

Inclusion Criteria:

Inclusion criteria:

  • 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.

Exclusion criteria:

  • 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.

Sites / Locations

  • Pain Management Center of Paducah

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Celestone

sodium chloride solution

sodium choride solution

Double substitutes

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Numeric rating scale (NRS), Oswestry Disability Index (ODI),
duration of significant pain relief, opioid intake, and return to work

Secondary Outcome Measures

Adverse event profile of side effects and complications.
Record side effects and any complications

Full Information

First Posted
January 19, 2010
Last Updated
April 24, 2017
Sponsor
Pain Management Center of Paducah
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1. Study Identification

Unique Protocol Identification Number
NCT01053572
Brief Title
Role of Steroids and 10% Hypertonic Sodium Chloride in Adhesiolysis in Post Lumbar Surgery Syndrome Patients
Official Title
Evaluation of the Role of Steroids and 10% Hypertonic Sodium Chloride in Adhesiolysis in Post Lumbar Surgery Syndrome Patients: A Prospective, Randomized, Double-Blind, Equivalence, Controlled Trial of Percutaneous Lumbar Adhesiolysis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
February 2010 (Actual)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Recruitment is indicated in patients with chronic low back pain and lower extremity pain secondary to post lumbar laminectomy syndrome, non-responsive to conservative therapy with physical therapy, chiropractic, medical therapy, and fluoroscopically directed epidural injections. This is a single-center, prospective, randomized, double-blind, equivalence, controlled trial performed in an interventional pain management referral center in the United States. The study involves 240 patients studied in 4 groups with 60 patients in each group. Randomization includes sequence generation, allocation concealment, implementation, and blinding. Data management analysis includes sample size justification of 40 patients in each group with a power of 80% and a 0.05% 2-sided significance level. Statistical methodology includes chi-squared statistics, Fisher's exact test, t-test, and paired t-test with significance evaluated at P value < 0.05.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Chronic low back pain, Post lumbar laminectomy syndrome, Lower extremity pain, Local anesthetic, Steroid, Percutaneous lumbar adhesiolysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Celestone
Arm Type
Active Comparator
Arm Description
Group I will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and non-particulate Celestone
Arm Title
sodium chloride solution
Arm Type
Active Comparator
Arm Description
Group II will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and 0.9% sodium chloride solution to substitute for non-particulate Celestone
Arm Title
sodium choride solution
Arm Type
Active Comparator
Arm Description
Group III will receive adhesiolysis, local anesthetic, normal sodium chloride solution instead of 10% hypertonic sodium chloride solution and non-particulate Celestone;
Arm Title
Double substitutes
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Adhesiolysis
Other Intervention Name(s)
Adhesiolysis in post-surgery
Intervention Description
Group I will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and non-particulate Celestone
Primary Outcome Measure Information:
Title
Numeric rating scale (NRS), Oswestry Disability Index (ODI),
Description
duration of significant pain relief, opioid intake, and return to work
Time Frame
Outcomes are measured at baseline and at 3, 6, 12, 18, and 24 months post-treatment.
Secondary Outcome Measure Information:
Title
Adverse event profile of side effects and complications.
Description
Record side effects and any complications
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion criteria: 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. Exclusion criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laxmaiah Manchikanti, MD
Organizational Affiliation
PMC of Paducah
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pain Management Center of Paducah
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42001
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Role of Steroids and 10% Hypertonic Sodium Chloride in Adhesiolysis in Post Lumbar Surgery Syndrome Patients

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