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

NCT ID: NCT01335646

Last Updated: 2020-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-21
• Study Completion Date: 2018-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Surgery

Group Type: ACTIVE_COMPARATOR

Lumbar Microdiscectomy

Intervention Type: PROCEDURE

lumbar discectomy within 1 month of randomization

Non-operative

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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

Interventions

Lumbar Microdiscectomy

lumbar discectomy within 1 month of randomization

Intervention Type: PROCEDURE

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Physicians' Services Incorporated Foundation

OTHER

Sponsor Role: collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: collaborator

The London Spine Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

London Health Science Centre

London, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 32187469 (View on PubMed)

Other Identifiers

UWO16000

Identifier Type: -

Identifier Source: org_study_id