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

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.

Study Overview

• Status: Completed
• Conditions: Lumbar Radiculopathy; Lumbar Spine Disc Herniation
• Intervention / Treatment: Procedure: Lumbar Microdiscectomy; Other: Physiotherapy, Epidural injections, Education, Pain Medications, Anti-inflammatories

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6G 5L7
      • London Health Science Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Surgery	Procedure: Lumbar Microdiscectomy; lumbar discectomy within 1 month of randomization
Active Comparator: Non-operative	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale for leg pain intensity	(Scale 0-10: 0 = no pain, 10 worst pain)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale for leg pain intensity	(Scale 0-10: 0 = no pain, 10 worst pain)	enrollment, 6 weeks, 3 months, 6 months, 1 year
Visual Analogue Scale for central back pain intensity	(Scale 0-10: 0 = no pain, 10 worst pain)	enrollment, 6 weeks, 3 months, 6 months, 1 year
Visual Analogue Scale for leg pain frequency	(Scale 0-10: 0 = no pain, 10 worst pain)	enrollment, 6 weeks, 3 months, 6 months, 1 year
Visual Analogue Scale for central back pain frequency	(Scale 0-10: 0 = no pain, 10 worst pain)	enrollment, 6 weeks, 3 months, 6 months, 1 year
Oswestry Disability Index	Scale 0-100; 0= no disability, 100 worst disability)	enrollment, 6 weeks, 3 months, 6 months, 1 year
SF36 - Generic Health Outcome Measure	physical component summary score and mental component summary score, higher scores indicate better quality of life	enrollment, 6 weeks, 3 months, 6 months, 1 year
Return to Work Status (% of patients employed)	Employed vs unemployed	enrollment, 6 weeks, 3 months, 6 months, 1 year
Satisfaction with treatment (% of patients satisfied with treatment)	satisfied vs unsatisfied	6 weeks, 3 months, 6 months, 1 year

Collaborators and Investigators

• Sponsor: The London Spine Centre
• Collaborators: Lawson Health Research Institute; The Physicians' Services Incorporated Foundation

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2010
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: April 13, 2011
• First Submitted That Met QC Criteria: April 13, 2011
• First Posted (Estimate): April 14, 2011

Study Record Updates

• Last Update Posted (Actual): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 6, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement; Radiculopathy; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Anti-Inflammatory Agents; Analgesics
• Other Study ID Numbers: UWO16000