Clinical trial NCT01335646: Surgery Versus Standardized Non-operative Care for the Treatment of Lumbar Disc Herniations: A Canadian Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Spine Disc Herniation
Lumbar Radiculopathy
Lead sponsor: The London Spine Centre
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
name: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
First posted: 2011-04-14
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Visual Analogue Scale for leg pain intensity
timeFrame: 6 months
Secondary outcomes:
measure: Visual Analogue Scale for leg pain intensity
timeFrame: enrollment, 6 weeks, 3 months, 6 months, 1 year
measure: Visual Analogue Scale for central back pain intensity
timeFrame: enrollment, 6 weeks, 3 months, 6 months, 1 year
measure: Visual Analogue Scale for leg pain frequency
timeFrame: enrollment, 6 weeks, 3 months, 6 months, 1 year
measure: Visual Analogue Scale for central back pain frequency
timeFrame: enrollment, 6 weeks, 3 months, 6 months, 1 year
measure: Oswestry Disability Index
timeFrame: enrollment, 6 weeks, 3 months, 6 months, 1 year
measure: SF36 - Generic Health Outcome Measure
timeFrame: enrollment, 6 weeks, 3 months, 6 months, 1 year
measure: Return to Work Status (% of patients employed)
timeFrame: enrollment, 6 weeks, 3 months, 6 months, 1 year
measure: Satisfaction with treatment (% of patients satisfied with treatment)
timeFrame: 6 weeks, 3 months, 6 months, 1 year
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Science Centre
state: Ontario
Study officials:
References:
citation: 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.