Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by The London Spine Centre
Sponsor:
Collaborators:
The Physicians' Services Incorporated Foundation
Lawson Health Research Institute
Information provided by (Responsible Party):
The London Spine Centre
ClinicalTrials.gov Identifier:
NCT01335646
First received: April 13, 2011
Last updated: September 9, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Lumbar Spine Disc Herniation
Lumbar Radiculopathy
Procedure: Lumbar Microdiscectomy
Other: Physiotherapy, Epidural injections, Education, Pain Medications, Anti-inflammatories
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by The London Spine Centre:

Primary Outcome Measures:
  • Visual Analogue Scale for intensity of Sciatica [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: February 2010
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Surgery Procedure: Lumbar Microdiscectomy
lumbar discectomy within 1 month of randomization
Active Comparator: Non-operative 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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01335646

Contacts
Contact: Christopher S Bailey, MD 519-685-8500 ext 55358 chris.bailey@lhsc.on.ca

Locations
Canada, Ontario
London Health Science Centre Recruiting
London, Ontario, Canada, N6G 5L7
Contact: christopher S Bailey, MD    519-685-8500 ext 55358    chris.bailey@lhsc.on.ca   
Sponsors and Collaborators
The London Spine Centre
The Physicians' Services Incorporated Foundation
Lawson Health Research Institute
  More Information

No publications provided

Responsible Party: The London Spine Centre
ClinicalTrials.gov Identifier: NCT01335646     History of Changes
Other Study ID Numbers: UWO16000
Study First Received: April 13, 2011
Last Updated: September 9, 2014
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Hernia
Radiculopathy
Nervous System Diseases
Neuromuscular Diseases
Pathological Conditions, Anatomical
Peripheral Nervous System Diseases
Analgesics
Anti-Inflammatory Agents
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014