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

Lumbar Radiculopathy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01335646
• Other study ID #: UWO16000
• Status: Completed
• Phase: N/A
• Start date: March 21, 2010
• Est. completion date: August 2018

Study information

• Verified date: March 2020
• Source: The London Spine Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Lumbar Radiculopathy
• Lumbar Spine Disc Herniation
• Radiculopathy

Intervention

Procedure:
• Lumbar Microdiscectomy
lumbar discectomy within 1 month of randomization

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

Locations

Country	Name	City	State
Canada	London Health Science Centre	London	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
The London Spine Centre	Lawson Health Research Institute, The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale for leg pain intensity	(Scale 0-10: 0 = no pain, 10 worst pain)	6 months
Secondary	Visual Analogue Scale for leg pain intensity	(Scale 0-10: 0 = no pain, 10 worst pain)	enrollment, 6 weeks, 3 months, 6 months, 1 year
Secondary	Visual Analogue Scale for central back pain intensity	(Scale 0-10: 0 = no pain, 10 worst pain)	enrollment, 6 weeks, 3 months, 6 months, 1 year
Secondary	Visual Analogue Scale for leg pain frequency	(Scale 0-10: 0 = no pain, 10 worst pain)	enrollment, 6 weeks, 3 months, 6 months, 1 year
Secondary	Visual Analogue Scale for central back pain frequency	(Scale 0-10: 0 = no pain, 10 worst pain)	enrollment, 6 weeks, 3 months, 6 months, 1 year
Secondary	Oswestry Disability Index	Scale 0-100; 0= no disability, 100 worst disability)	enrollment, 6 weeks, 3 months, 6 months, 1 year
Secondary	SF36 - Generic Health Outcome Measure	physical component summary score and mental component summary score, higher scores indicate better quality of life	enrollment, 6 weeks, 3 months, 6 months, 1 year
Secondary	Return to Work Status (% of patients employed)	Employed vs unemployed	enrollment, 6 weeks, 3 months, 6 months, 1 year
Secondary	Satisfaction with treatment (% of patients satisfied with treatment)	satisfied vs unsatisfied	6 weeks, 3 months, 6 months, 1 year