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

NCT01335646 | Completed

• 1 other identifier: UWO16000
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Spine Disc Herniation; Lumbar Radiculopathy

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale for leg pain intensity

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

  6 months

Secondary Outcomes (8)

• Visual Analogue Scale for leg pain intensity

  enrollment, 6 weeks, 3 months, 6 months, 1 year

• Visual Analogue Scale for central back pain intensity

  enrollment, 6 weeks, 3 months, 6 months, 1 year

• Visual Analogue Scale for leg pain frequency

  enrollment, 6 weeks, 3 months, 6 months, 1 year

• Visual Analogue Scale for central back pain frequency

  enrollment, 6 weeks, 3 months, 6 months, 1 year

• Oswestry Disability Index

  enrollment, 6 weeks, 3 months, 6 months, 1 year

Study Arms (2)

Surgery

ACTIVE COMPARATOR

Procedure: Lumbar Microdiscectomy

Non-operative

ACTIVE COMPARATOR

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

Interventions

Lumbar Microdiscectomy PROCEDURE

lumbar discectomy within 1 month of randomization

Surgery

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

Non-operative

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

London Health Science Centre

London, Ontario, N6G 5L7, Canada

Location

Related Publications (1)

• Bailey CS, Rasoulinejad P, Taylor D, Sequeira K, Miller T, Watson J, Rosedale R, Bailey SI, Gurr KR, Siddiqi F, Glennie A, Urquhart JC. Surgery versus Conservative Care for Persistent Sciatica Lasting 4 to 12 Months. N Engl J Med. 2020 Mar 19;382(12):1093-1102. doi: 10.1056/NEJMoa1912658.

  PMID: 32187469 DERIVED

MeSH Terms

Conditions

Radiculopathy

Interventions

Physical Therapy Modalities; Injections, Epidural; Educational Status; Anti-Inflammatory Agents

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Injections, Spinal; Injections; Drug Administration Routes; Drug Therapy; Socioeconomic Factors; Population Characteristics; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2011
• First Posted: April 14, 2011
• Study Start: March 21, 2010
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: March 10, 2020

Record last verified: 2020-03

Locations

CA (1)