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Surgery Versus Standardized Non-operative Care for the Treatment of Lumbar Disc Herniations: A Canadian Trial

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: NCT01335646
Recruitment Status : Completed
First Posted : April 14, 2011
Last Update Posted : March 10, 2020
Sponsor:
Collaborators:
The Physicians' Services Incorporated Foundation
Lawson Health Research Institute
Information provided by (Responsible Party):
The London Spine Centre

Tracking Information
First Submitted Date  ICMJE April 13, 2011
First Posted Date  ICMJE April 14, 2011
Last Update Posted Date March 10, 2020
Actual Study Start Date  ICMJE March 21, 2010
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2020)
Visual Analogue Scale for leg pain intensity [ Time Frame: 6 months ]
(Scale 0-10: 0 = no pain, 10 worst pain)
Original Primary Outcome Measures  ICMJE
 (submitted: April 13, 2011)
Visual Analogue Scale for intensity of Sciatica [ Time Frame: 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2020)
  • Visual Analogue Scale for leg pain intensity [ Time Frame: enrollment, 6 weeks, 3 months, 6 months, 1 year ]
    (Scale 0-10: 0 = no pain, 10 worst pain)
  • Visual Analogue Scale for central back pain intensity [ Time Frame: enrollment, 6 weeks, 3 months, 6 months, 1 year ]
    (Scale 0-10: 0 = no pain, 10 worst pain)
  • Visual Analogue Scale for leg pain frequency [ Time Frame: enrollment, 6 weeks, 3 months, 6 months, 1 year ]
    (Scale 0-10: 0 = no pain, 10 worst pain)
  • Visual Analogue Scale for central back pain frequency [ Time Frame: enrollment, 6 weeks, 3 months, 6 months, 1 year ]
    (Scale 0-10: 0 = no pain, 10 worst pain)
  • Oswestry Disability Index [ Time Frame: enrollment, 6 weeks, 3 months, 6 months, 1 year ]
    Scale 0-100; 0= no disability, 100 worst disability)
  • SF36 - Generic Health Outcome Measure [ Time Frame: enrollment, 6 weeks, 3 months, 6 months, 1 year ]
    physical component summary score and mental component summary score, higher scores indicate better quality of life
  • Return to Work Status (% of patients employed) [ Time Frame: enrollment, 6 weeks, 3 months, 6 months, 1 year ]
    Employed vs unemployed
  • Satisfaction with treatment (% of patients satisfied with treatment) [ Time Frame: 6 weeks, 3 months, 6 months, 1 year ]
    satisfied vs unsatisfied
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Surgery Versus Standardized Non-operative Care for the Treatment of Lumbar Disc Herniations: A Canadian Trial
Official Title  ICMJE Not Provided
Brief Summary The objective of this study is to determine if surgery is superior to non-operative care for sciatica caused by a lumbar disc herniation. This study will include patients that have had severe sciatica for greater than 4 months which reflects the wait time of the Canadian health care system. This study is an opportunity to make an important contribution to medical science as there is no "top tier" evidence for or against this highly prevalent surgery. Although there have been several recent randomized trials in the field, all have been marred by a large number of patient crossing over from non-operative to operative treatment. Due to the wait for spine surgery, the Canadian system has a built-in delay that prevents such a cross over of patients. This study capitalizes on this unique opportunity to perform a high caliber surgical trial. Patients consenting to be in the study will be randomly assigned to expedited surgery within three weeks or standardized non-operative care while they wait on the surgeons list for consultation and then surgery (minimum wait of 9 months). The study will assess pain, function, quality of life, satisfaction, and work status to determine if one treatment is superior.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Lumbar Spine Disc Herniation
  • Lumbar Radiculopathy
Intervention  ICMJE
  • Procedure: Lumbar Microdiscectomy
    lumbar discectomy within 1 month of randomization
  • Other: Physiotherapy, Epidural injections, Education, Pain Medications, Anti-inflammatories
    Physiotherapy following standardized protocol Epidurals - Depomedrol 80 mg plus 10cc of 0.35% Lidocaine Education to occur at each visit Medications may include: NSAIDS; Acetaminophen with codeine or oxycodone or tramadol; Amitriptyline or Neurontin or Pregabalin
Study Arms  ICMJE
  • Active Comparator: Surgery
    Intervention: Procedure: Lumbar Microdiscectomy
  • Active Comparator: Non-operative
    Intervention: Other: Physiotherapy, Epidural injections, Education, Pain Medications, Anti-inflammatories
Publications * Bailey CS, Rasoulinejad P, Taylor D, Sequeira K, Miller T, Watson J, Rosedale R, Bailey SI, Gurr KR, Siddiqi F, Glennie A, Urquhart JC. Surgery versus Conservative Care for Persistent Sciatica Lasting 4 to 12 Months. N Engl J Med. 2020 Mar 19;382(12):1093-1102. doi: 10.1056/NEJMoa1912658.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2017)
128
Original Estimated Enrollment  ICMJE
 (submitted: April 13, 2011)
140
Actual Study Completion Date  ICMJE August 2018
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 18 - 60 years old
  2. Unilateral, single L5 or S1 radiculopathy (leg pain following dermatomal distribution of L5 or S1)

    • Leg dominant pain over central back pain
    • Positive straight leg raise <70 degrees
  3. MRI with corresponding L4-5 or L5-S1 posterolateral disc herniation*
  4. Radicular symptom duration greater than 4 months and less than 12 months. May be recurrent if first episode occurred within 12 months and duration of presenting episode is greater than 4 months.
  5. Agree to possible discectomy

Exclusion Criteria:

  1. Radiculopathy secondary to foraminal stenosis
  2. Radiculopathy secondary to intra-foraminal or far lateral disc herniation
  3. Radiculopathy secondary to lumbar central or lateral recess stenosis not caused by a posterolateral disc herniation
  4. Previous lumbar surgery at involved level
  5. Lumbar spondylolisthesis or lateral listhesis at level of disc herniation
  6. Lumbar Scoliosis greater than 10 degrees
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01335646
Other Study ID Numbers  ICMJE UWO16000
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party The London Spine Centre
Original Responsible Party Christopher Stewart Bailey, London Spine Centre
Current Study Sponsor  ICMJE The London Spine Centre
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • The Physicians' Services Incorporated Foundation
  • Lawson Health Research Institute
Investigators  ICMJE Not Provided
PRS Account The London Spine Centre
Verification Date March 2020

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