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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Laxmaiah Manchikanti, MD, Pain Management Center of Paducah
ClinicalTrials.gov Identifier:
NCT01053572
First received: January 19, 2010
Last updated: March 21, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention
Low Back Pain
 Drug: Celestone
Drug: Substitute Celestone
Drug: Substitute Hypertonic Sodium Chloride
Drug: Substitute hypertonic sodium chloride and Celestone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Further study details as provided by Pain Management Center of Paducah:

Primary Outcome Measures:
  • Numeric rating scale (NRS), Oswestry Disability Index (ODI), 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Adverse event profile of side effects and 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. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 240
Study Start Date: February 2010
Estimated Study Completion Date: January 2014
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Celestone
Group I will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and non-particulate Celestone
 Drug: Celestone
Group I will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and non-particulate Celestone
Active Comparator: sodium chloride solution
Group II will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and 0.9% sodium chloride solution to substitute for non-particulate Celestone
 Drug: Substitute Celestone
Group II will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and 0.9% sodium chloride solution to substitute for non-particulate Celestone
Active Comparator: sodium choride solution
Group III will receive adhesiolysis, local anesthetic, normal sodium chloride solution instead of 10% hypertonic sodium chloride solution and non-particulate Celestone;
 Drug: Substitute Hypertonic Sodium Chloride
Group III will receive adhesiolysis, local anesthetic, normal sodium chloride solution instead of 10% hypertonic sodium chloride solution and non-particulate Celestone
Active Comparator: Double substitutes
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
 Drug: Substitute hypertonic sodium chloride and 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01053572

Locations
United States, Kentucky
Pain Management Center of Paducah
Paducah, Kentucky, United States, 42001
Sponsors and Collaborators
Pain Management Center of Paducah
  More Information

No publications provided

Responsible Party: Laxmaiah Manchikanti, MD, Medical Director, Pain Management Center of Paducah
ClinicalTrials.gov Identifier: NCT01053572     History of Changes
Other Study ID Numbers: Protocol 23
Study First Received: January 19, 2010
Last Updated: March 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Pain Management Center of Paducah:
Chronic low back pain
Post lumbar laminectomy syndrome
Lower extremity pain
 Local anesthetic
Steroid
Percutaneous lumbar adhesiolysis

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anesthetics, Local
Anesthetics
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone sodium phosphate
Central Nervous System Depressants
 Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on May 21, 2013