NCT01335646

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: The London Spine Centre · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lumbar Spine Disc Herniation
• Lumbar Radiculopathy

Interventions

Type	Name	Description
PROCEDURE	Lumbar Microdiscectomy	lumbar discectomy within 1 month of randomization
OTHER	Physiotherapy, 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

Timeline

• Start date: 2010-03-21
• Primary completion: 2018-08-01
• Completion: 2018-08-01
• First posted: 2011-04-14
• Last updated: 2020-03-10

Locations

1 site across 1 country: Canada