Lumbar Radiculopathy, Lumbar Spine Disc Herniation
Conditions
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.
Interventions
PROCEDURELumbar Microdiscectomy
lumbar discectomy within 1 month of randomization
OTHERPhysiotherapy, 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
Sponsors
The Physicians' Services Incorporated Foundation
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
The London Spine Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale for leg pain intensity | 6 months | (Scale 0-10: 0 = no pain, 10 worst pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale for leg pain intensity | 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 | 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 | 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 | enrollment, 6 weeks, 3 months, 6 months, 1 year | (Scale 0-10: 0 = no pain, 10 worst pain) |
| Oswestry Disability Index | enrollment, 6 weeks, 3 months, 6 months, 1 year | Scale 0-100; 0= no disability, 100 worst disability) |
| SF36 - Generic Health Outcome Measure | 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) | enrollment, 6 weeks, 3 months, 6 months, 1 year | Employed vs unemployed |
| Satisfaction with treatment (% of patients satisfied with treatment) | 6 weeks, 3 months, 6 months, 1 year | satisfied vs unsatisfied |
Countries
Canada
Outcome results
None listed