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

NCT01335646 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2020-03-10

No results posted yet for this study

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

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

Sponsors & Collaborators

  • The Physicians' Services Incorporated Foundation

    collaborator OTHER

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    collaborator OTHER

  • The London Spine Centre

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-21
Primary Completion
2018-08-31
Completion
2018-08-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01335646 on ClinicalTrials.gov