Surgery Versus Standardized Non-operative Care for the Treatment of Lumbar Disc Herniations: A Canadian Trial
Primary Purpose
Lumbar Spine Disc Herniation, Lumbar Radiculopathy
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Lumbar Microdiscectomy
Physiotherapy, Epidural injections, Education, Pain Medications, Anti-inflammatories
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Spine Disc Herniation
Eligibility Criteria
Inclusion Criteria:
- 18 - 60 years old
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
- MRI with corresponding L4-5 or L5-S1 posterolateral disc herniation*
- 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.
- Agree to possible discectomy
Exclusion Criteria:
- Radiculopathy secondary to foraminal stenosis
- Radiculopathy secondary to intra-foraminal or far lateral disc herniation
- Radiculopathy secondary to lumbar central or lateral recess stenosis not caused by a posterolateral disc herniation
- Previous lumbar surgery at involved level
- Lumbar spondylolisthesis or lateral listhesis at level of disc herniation
- Lumbar Scoliosis greater than 10 degrees
Sites / Locations
- London Health Science Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Surgery
Non-operative
Arm Description
Outcomes
Primary Outcome Measures
Visual Analogue Scale for leg pain intensity
(Scale 0-10: 0 = no pain, 10 worst pain)
Secondary Outcome Measures
Visual Analogue Scale for leg pain intensity
(Scale 0-10: 0 = no pain, 10 worst pain)
Visual Analogue Scale for central back pain intensity
(Scale 0-10: 0 = no pain, 10 worst pain)
Visual Analogue Scale for leg pain frequency
(Scale 0-10: 0 = no pain, 10 worst pain)
Visual Analogue Scale for central back pain frequency
(Scale 0-10: 0 = no pain, 10 worst pain)
Oswestry Disability Index
Scale 0-100; 0= no disability, 100 worst disability)
SF36 - Generic Health Outcome Measure
physical component summary score and mental component summary score, higher scores indicate better quality of life
Return to Work Status (% of patients employed)
Employed vs unemployed
Satisfaction with treatment (% of patients satisfied with treatment)
satisfied vs unsatisfied
Full Information
NCT ID
NCT01335646
First Posted
April 13, 2011
Last Updated
March 6, 2020
Sponsor
The London Spine Centre
Collaborators
The Physicians' Services Incorporated Foundation, Lawson Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01335646
Brief Title
Surgery Versus Standardized Non-operative Care for the Treatment of Lumbar Disc Herniations: A Canadian Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 21, 2010 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The London Spine Centre
Collaborators
The Physicians' Services Incorporated Foundation, Lawson Health Research Institute
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spine Disc Herniation, Lumbar Radiculopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Surgery
Arm Type
Active Comparator
Arm Title
Non-operative
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Lumbar Microdiscectomy
Intervention Description
lumbar discectomy within 1 month of randomization
Intervention Type
Other
Intervention Name(s)
Physiotherapy, Epidural injections, Education, Pain Medications, Anti-inflammatories
Intervention Description
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
Primary Outcome Measure Information:
Title
Visual Analogue Scale for leg pain intensity
Description
(Scale 0-10: 0 = no pain, 10 worst pain)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Visual Analogue Scale for leg pain intensity
Description
(Scale 0-10: 0 = no pain, 10 worst pain)
Time Frame
enrollment, 6 weeks, 3 months, 6 months, 1 year
Title
Visual Analogue Scale for central back pain intensity
Description
(Scale 0-10: 0 = no pain, 10 worst pain)
Time Frame
enrollment, 6 weeks, 3 months, 6 months, 1 year
Title
Visual Analogue Scale for leg pain frequency
Description
(Scale 0-10: 0 = no pain, 10 worst pain)
Time Frame
enrollment, 6 weeks, 3 months, 6 months, 1 year
Title
Visual Analogue Scale for central back pain frequency
Description
(Scale 0-10: 0 = no pain, 10 worst pain)
Time Frame
enrollment, 6 weeks, 3 months, 6 months, 1 year
Title
Oswestry Disability Index
Description
Scale 0-100; 0= no disability, 100 worst disability)
Time Frame
enrollment, 6 weeks, 3 months, 6 months, 1 year
Title
SF36 - Generic Health Outcome Measure
Description
physical component summary score and mental component summary score, higher scores indicate better quality of life
Time Frame
enrollment, 6 weeks, 3 months, 6 months, 1 year
Title
Return to Work Status (% of patients employed)
Description
Employed vs unemployed
Time Frame
enrollment, 6 weeks, 3 months, 6 months, 1 year
Title
Satisfaction with treatment (% of patients satisfied with treatment)
Description
satisfied vs unsatisfied
Time Frame
6 weeks, 3 months, 6 months, 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 - 60 years old
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
MRI with corresponding L4-5 or L5-S1 posterolateral disc herniation*
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.
Agree to possible discectomy
Exclusion Criteria:
Radiculopathy secondary to foraminal stenosis
Radiculopathy secondary to intra-foraminal or far lateral disc herniation
Radiculopathy secondary to lumbar central or lateral recess stenosis not caused by a posterolateral disc herniation
Previous lumbar surgery at involved level
Lumbar spondylolisthesis or lateral listhesis at level of disc herniation
Lumbar Scoliosis greater than 10 degrees
Facility Information:
Facility Name
London Health Science Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6G 5L7
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
32187469
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.
Results Reference
derived
Learn more about this trial
Surgery Versus Standardized Non-operative Care for the Treatment of Lumbar Disc Herniations: A Canadian Trial
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