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Completed

NCT Number: NCT01335646

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

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.

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Key information

Conditions

Lumbar Spine Disc Herniation Lumbar Radiculopathy Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Radiculopathy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

London Health Science Centre

London, Ontario, N6G 5L7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 - 60 years old
  • 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
  • MRI with corresponding L4-5 or L5-S1 posterolateral disc herniation*
  • 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.
  • Agree to possible discectomy

Exclusion criteria

  • Radiculopathy secondary to foraminal stenosis
  • Radiculopathy secondary to intra-foraminal or far lateral disc herniation
  • Radiculopathy secondary to lumbar central or lateral recess stenosis not caused by a posterolateral disc herniation
  • Previous lumbar surgery at involved level
  • Lumbar spondylolisthesis or lateral listhesis at level of disc herniation
  • Lumbar Scoliosis greater than 10 degrees

Treatment and study plan

Lumbar Microdiscectomy

Procedure

lumbar discectomy within 1 month of randomization

Physiotherapy, Epidural injections, Education, Pain Medications, Anti-inflammatories

Other

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

Primary outcomes

  1. Visual Analogue Scale for leg pain intensity

    Time frame: 6 months

    (Scale 0-10: 0 = no pain, 10 worst pain)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

The London Spine Centre

Other

Collaborators

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
  • The Physicians' Services Incorporated Foundation

Registry information

Important dates

Study start
2010
Primary completion
2018
Study completion
2018
First posted
Apr 14, 2011
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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