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

Not Applicable

Completed

• Conditions: Lumbar Spine Disc Herniation; Lumbar Radiculopathy
• Interventions: Procedure: Lumbar Microdiscectomy; Other: Physiotherapy, Epidural injections, Education, Pain Medications, Anti-inflammatories

• Registration Number: NCT01335646
• Lead Sponsor: The London Spine Centre

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-21
• Study First Submitted: 2011-04-13
• Study First Submitted QC: 2011-04-13
• Study First Posted: 2011-04-14
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-06
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgery	Lumbar Microdiscectomy	-
Non-operative	Physiotherapy, Epidural injections, Education, Pain Medications, Anti-inflammatories	-

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale for leg pain intensity	6 months	(Scale 0-10: 0 = no pain, 10 worst pain)

Secondary Outcome Measures

Name	Time	Method
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)
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)
Satisfaction with treatment (% of patients satisfied with treatment)	6 weeks, 3 months, 6 months, 1 year	satisfied vs unsatisfied
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

Trial Locations

Locations (1)

London Health Science Centre; 🇨🇦 London, Ontario, Canada