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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01335646
Recruitment Status : Completed
First Posted : April 14, 2011
Last Update Posted : March 10, 2020
Sponsor:
Collaborators:
The Physicians' Services Incorporated Foundation
Lawson Health Research Institute
Information provided by (Responsible Party):
The London Spine Centre

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Actual Study Start Date : March 21, 2010
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Visual Analogue Scale for leg pain intensity [ Time Frame: 6 months ]
    (Scale 0-10: 0 = no pain, 10 worst pain)


Secondary Outcome Measures :
  1. Visual Analogue Scale for leg pain intensity [ Time Frame: enrollment, 6 weeks, 3 months, 6 months, 1 year ]
    (Scale 0-10: 0 = no pain, 10 worst pain)

  2. Visual Analogue Scale for central back pain intensity [ Time Frame: enrollment, 6 weeks, 3 months, 6 months, 1 year ]
    (Scale 0-10: 0 = no pain, 10 worst pain)

  3. Visual Analogue Scale for leg pain frequency [ Time Frame: enrollment, 6 weeks, 3 months, 6 months, 1 year ]
    (Scale 0-10: 0 = no pain, 10 worst pain)

  4. Visual Analogue Scale for central back pain frequency [ Time Frame: enrollment, 6 weeks, 3 months, 6 months, 1 year ]
    (Scale 0-10: 0 = no pain, 10 worst pain)

  5. Oswestry Disability Index [ Time Frame: enrollment, 6 weeks, 3 months, 6 months, 1 year ]
    Scale 0-100; 0= no disability, 100 worst disability)

  6. SF36 - Generic Health Outcome Measure [ Time Frame: 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

  7. Return to Work Status (% of patients employed) [ Time Frame: enrollment, 6 weeks, 3 months, 6 months, 1 year ]
    Employed vs unemployed

  8. Satisfaction with treatment (% of patients satisfied with treatment) [ Time Frame: 6 weeks, 3 months, 6 months, 1 year ]
    satisfied vs unsatisfied


Eligibility Criteria
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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
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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


Locations
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Canada, Ontario
London Health Science Centre
London, Ontario, Canada, N6G 5L7
Sponsors and Collaborators
The London Spine Centre
The Physicians' Services Incorporated Foundation
Lawson Health Research Institute
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: The London Spine Centre
ClinicalTrials.gov Identifier: NCT01335646    
Other Study ID Numbers: UWO16000
First Posted: April 14, 2011    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Additional relevant MeSH terms:
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Intervertebral Disc Displacement
Radiculopathy
Hernia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pathological Conditions, Anatomical
Spinal Diseases
 Bone Diseases
Musculoskeletal Diseases
Anti-Inflammatory Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs