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

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

Tracking Information

• First Submitted Date: April 13, 2011
• First Posted Date: April 14, 2011
• Last Update Posted Date: March 10, 2020
• Actual Study Start Date: March 21, 2010
• Actual Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: April 13, 2011): Visual Analogue Scale for intensity of Sciatica [ Time Frame: 6 months ]

Current Secondary Outcome Measures (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: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Surgery Versus Standardized Non-operative Care for the Treatment of Lumbar Disc Herniations: A Canadian Trial
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment

Condition

• Lumbar Spine Disc Herniation
• Lumbar Radiculopathy

Intervention

• 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

• 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.

Recruitment Information

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

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT01335646
• Other Study ID Numbers: UWO16000
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: The London Spine Centre
• Original Responsible Party: Christopher Stewart Bailey, London Spine Centre
• Current Study Sponsor: The London Spine Centre
• Original Study Sponsor: Same as current

Collaborators

• The Physicians' Services Incorporated Foundation
• Lawson Health Research Institute

• Investigators: Not Provided
• PRS Account: The London Spine Centre
• Verification Date: March 2020