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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
128
lumbar discectomy within 1 month of randomization
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
London Health Science Centre
London, Ontario, Canada
Visual Analogue Scale for leg pain intensity
(Scale 0-10: 0 = no pain, 10 worst pain)
Time frame: 6 months
Visual Analogue Scale for leg pain intensity
(Scale 0-10: 0 = no pain, 10 worst pain)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: enrollment, 6 weeks, 3 months, 6 months, 1 year
Oswestry Disability Index
Scale 0-100; 0= no disability, 100 worst disability)
Time frame: 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
Time frame: enrollment, 6 weeks, 3 months, 6 months, 1 year
Return to Work Status (% of patients employed)
Employed vs unemployed
Time frame: enrollment, 6 weeks, 3 months, 6 months, 1 year
Satisfaction with treatment (% of patients satisfied with treatment)
satisfied vs unsatisfied
Time frame: 6 weeks, 3 months, 6 months, 1 year
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