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Preoperative Corticosteroid Epidural Injection and Lumbar Decompression Surgery Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03543033
Recruitment Status : Withdrawn (The study was closed by the investigators due to lack of study population to enroll.)
First Posted : June 1, 2018
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
Lahey Clinic

Tracking Information
First Submitted Date  ICMJE April 11, 2018
First Posted Date  ICMJE June 1, 2018
Last Update Posted Date June 18, 2020
Actual Study Start Date  ICMJE September 10, 2018
Actual Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2018)
Opioid Use - conversion to oral morphine equivalents using standard table [ Time Frame: Primary endpoint is 3 Months ]
Following spine surgery, # of prescription opioid pills used will be recorded and converted to oral morphine equivalents using a standard table. Information collected will include # of pills taken, # of prescription refills, and respective dates.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2018)
  • Disability - Oswestry Disability Index (ODI) [ Time Frame: Baseline, 1 week post-op, 1 month post-op, and 3 months post-op ]
    Oswestry Disability Index (ODI) will be used to measure disability associated with their spinal condition. The ODI contains 10 questions; each with 6 choices and each answer choice ranges from 0 to 5 points. The minimum score is 0 and maximum score is 50; the higher the score, the greater the disability indicated. Each question is 5 points each and is summed then divided by total possible point. Scores from each cohort will be compared.
  • Pain - Visual Analog Scale (VAS) [ Time Frame: Baseline, 1 week post-op, 1 month post-op, and 3 months post-op ]
    VAS will be used to measure pain and discomfort. The scale is a horizontal line numbered 0 through 10 with "0" indicating no pain, "5" indicating moderate pain, and 10 indicating worst pain. Patients will be instructed to mark an "X" on the number corresponding to their level of back pain over the past week. They will also be asked to indicate their leg pain on a similar, but separate scale. Scores from each cohort will be compared.
  • Quality of Life - EuroQol-5D [ Time Frame: Baseline, 1 week post-op, 1 month post-op, and 3 months post-op ]
    EuroQol-5D (EQ-5D) will be used to measure quality of life. The EQ-5D includes 5 multiple-choice questions with 3 choices each; each choice corresponding to a value of 1,2,or 3. Each value is entered into an algorithm that computes a score. The score can range from "1" = high quality of life" and "0" = poor quality of life. Scores will be compared between both cohorts.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2018)
  • Post Operative Pain - ODI [ Time Frame: Baseline, 1 week post-op, 1 month post-op, and 3 months post-op ]
    Oswestry Disability Index (ODI) will be used to measure postoperative pain Scores from each cohort will be compared.
  • Post Operative Pain - VAS [ Time Frame: Baseline, 1 week post-op, 1 month post-op, and 3 months post-op ]
    VAS will be used to measure postoperative pain and discomfort. Scores will be compared between both cohorts.
  • Post Operative Pain - EQ5D [ Time Frame: Baseline, 1 week post-op, 1 month post-op, and 3 months post-op ]
    EuroQol-5D (EQ-5D) will be used to measure postoperative pain and discomfort. Scores will be compared between both cohorts.
Current Other Pre-specified Outcome Measures
 (submitted: May 30, 2018)
Cost Analysis - Health Resource Diary [ Time Frame: 1 week post-op, 1 month post-op, 3 months post-op ]
A self-administered health resource diary will be completed by the patient. Information on co payments, travel costs, medical devices, and medical tests will be collected. Along with their estimated costs or receipts.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Preoperative Corticosteroid Epidural Injection and Lumbar Decompression Surgery Outcomes
Official Title  ICMJE Randomized Control Trial Comparing Pain and Functional Outcome Following Single Level Lumbar Nerve Decompression Surgery With or Without Preoperative Corticosteroid Epidural Injection
Brief Summary This randomized control trial will compare opioid use, pain, and functional outcomes following decompression surgery for single-level lumbar radiculopathy in patients who undergo placement of corticosteroid epidural injection within 2 weeks prior to surgery compared to those who do not. The hypothesis of this study is that patients who receive the preoperative corticosteroid injection will have less reduced postoperative opioid use, as well as earlier mobilization, reduced length of stay, and faster return to work compared to control patients who do not receive the injection.
Detailed Description

This is a randomized control study that will be completed within the Department of Neurosurgery at Lahey Hospital & Medical Center. Patients will undergo their recommended surgery to treat single-level lumbar radiculopathy. Patients who are randomized to and consent to receiving a preoperative corticosteroid injection will report to clinic within 2 weeks prior to date of surgery to receive a corticosteroid injection. These subjects will first receive a topical anesthesia to the skin and underlying tissue in a maximum amount of 5 ml of 1% Lidocaine. Following this application, an 18-20 gauge epidural needle will be used to inject a solution containing 80 mg Depo-Medrol in 1 ml of 1% PF Lidocaine and 5ml of sterile PF saline. To assure the injection is epidural, we will be using loss of resistance technique under fluoroscopy and epidural placement will be confirmed with the live-image instillation in the AP and lateral positions of dye, with pattern confirming epidermal needle placement.

All patients will complete health outcome questionnaires (VAS, EQ-5D, ODI) at baseline (treatment cohort: prior to injection, control cohort: prior to spine surgery), 1 week post-op, 1 month post-op, and 3 months post-op. Patients will be instructed to bring all condition-related pain medication containers to each follow-up for research measuring purposes. Research personnel will record number of pills remaining in container, number of opioid prescription refills, and respective dates. Opioid usage for each subject will be tracked and converted to mg oral morphine equivalents using a standard table. Research personnel will capture additional clinic information such as length of stay, length of time before ambulation, and occurrence of any complications (i.e. DVT, infection). Opioid use, muscle relaxants, and other pain medication use will be followed for 3 months. At baseline and at each post-op follow up, patients will be asked to define their use of illicit drugs over the past 6 months (heroin, cocaine, marijuana, methamphetamine, other). Return to work date and work status will be captured out to 3 months. Patients will submit a health-cost diary at 1 week, 1 month, and 3 months, and this data will be combined with hospital-based cost information to generate a cost analysis. This diary will capture costs such as medication costs, copayments, travel, etc. Additionally, all patient surgery cancelations as well as reason for cancelation will be recorded. No additional medical testing will be required by the patient.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized Control Trial with randomization ratio 1:1
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Lumbar Radiculopathy
Intervention  ICMJE Drug: Corticosteroid injection
These subjects will first receive a topical anesthesia to the skin and underlying tissue in a maximum amount of 5 ml of 1% Lidocaine. Following this application, an 18-20 gauge epidural needle will be used to inject a solution containing 80 mg Depo-Medrol in 1 ml of 1% PF Lidocaine and 5ml of sterile PF saline
Study Arms  ICMJE
  • Experimental: Treatment
    Patients will receive a corticosteroid epidural injection within 2 weeks of their scheduled lumbar surgery
    Intervention: Drug: Corticosteroid injection
  • No Intervention: Control
    Patients will not receive a corticosteroid injection within 2 weeks of their scheduled lumbar surgery.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 16, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: May 30, 2018)
60
Actual Study Completion Date  ICMJE May 1, 2020
Actual Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients 30-75 years of age
  2. Patients diagnosed with diagnoses with single level unilateral lumbar radiculopathy
  3. Patients diagnosed with spinal stenosis or disc herniation
  4. Patients who have a history of > 6 weeks of at least 1 conservative treatment
  5. ASA < III

Exclusion Criteria:

  1. Patients who have undergone previous lumbar spinal surgery at index level
  2. Patients diagnosed with spondylolisthesis at index level
  3. Patients currently taking anti-coagulant therapy
  4. Active treatment of major psychiatric condition such as major depression and/or anxiety disorder.
  5. Patients currently seeking or receiving workers compensation
  6. Patients who have undergone previous corticosteroid injection at index level
  7. Morbid obesity defined as BMI > 40
  8. Patients with history of chronic opioid use
  9. Patients with a contrast dye allergy
  10. Extruded disc fragment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03543033
Other Study ID Numbers  ICMJE 2018-008
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lahey Clinic
Study Sponsor  ICMJE Lahey Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Erica J Bial, M.D., M.S. Lahey Clinic
Principal Investigator: Robert G Whitmore, M.D. Lahey Clinic
PRS Account Lahey Clinic
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP