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

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ClinicalTrials.gov Identifier: NCT01335646
Recruitment Status : Recruiting
First Posted : April 14, 2011
Last Update Posted : July 13, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Actual Study Start Date : February 1, 2010
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Visual Analogue Scale for intensity of Sciatica [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: The London Spine Centre
ClinicalTrials.gov Identifier: NCT01335646     History of Changes
Other Study ID Numbers: UWO16000
First Posted: April 14, 2011    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017

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