Lumbar Spine Disc HerniationNCT01335646
Surgery Versus Standardized Non-operative Care for the Treatment of Lumbar Disc Herniations: A Canadian Trial
A study testing Lumbar Microdiscectomy and Physiotherapy, Epidural injections, Education, Pain Medications, Anti-inflammatories in people with Lumbar Spine Disc Herniation and Lumbar Radiculopathy, run by The London Spine Centre at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lumbar Spine Disc Herniation, Lumbar Radiculopathy
- What is being tested?
- Lumbar Microdiscectomy and Physiotherapy, Epidural injections, Education, Pain Medications, Anti-inflammatories
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteCanada
- Study dates
- 21 Mar 2010to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Lumbar Microdiscectomy, Physiotherapy, Epidural injections, Education, Pain Medications, Anti-inflammatories
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar MicrodiscectomyProcedure or surgery
lumbar discectomy within 1 month of randomization
Physiotherapy, Epidural injections, Education, Pain Medications, Anti-inflammatoriesOther
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
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Active comparator | Not described Receives: Procedure: Lumbar Microdiscectomy |
| Non-operative | Active comparator | Not described Receives: Other: Physiotherapy, Epidural injections, Education, Pain Medications, Anti-inflammatories |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale for leg pain intensity
(Scale 0-10: 0 = no pain, 10 worst pain)
Measured: 6 months
Secondary outcomes (8)
Visual Analogue Scale for leg pain intensity
(Scale 0-10: 0 = no pain, 10 worst pain)
Measured: enrollment, 6 weeks, 3 months, 6 months, 1 year
Visual Analogue Scale for central back pain intensity
(Scale 0-10: 0 = no pain, 10 worst pain)
Measured: enrollment, 6 weeks, 3 months, 6 months, 1 year
Visual Analogue Scale for leg pain frequency
(Scale 0-10: 0 = no pain, 10 worst pain)
Measured: enrollment, 6 weeks, 3 months, 6 months, 1 year
Visual Analogue Scale for central back pain frequency
(Scale 0-10: 0 = no pain, 10 worst pain)
Measured: enrollment, 6 weeks, 3 months, 6 months, 1 year
Oswestry Disability Index
Scale 0-100; 0= no disability, 100 worst disability)
Measured: enrollment, 6 weeks, 3 months, 6 months, 1 year
SF36 - Generic Health Outcome Measure
physical component summary score and mental component summary score, higher scores indicate better quality of life
Measured: enrollment, 6 weeks, 3 months, 6 months, 1 year
Return to Work Status (% of patients employed)
Employed vs unemployed
Measured: enrollment, 6 weeks, 3 months, 6 months, 1 year
Satisfaction with treatment (% of patients satisfied with treatment)
satisfied vs unsatisfied
Measured: 6 weeks, 3 months, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2011 (estimated)
- Study start21 Mar 2010
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lumbar Spine Disc HerniationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- The London Spine Centre
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01335646
- Sponsor's protocol ID
- UWO16000
- Status last verified
- Mar 2020
- First submitted
- 13 Apr 2011
- Last updated
- 10 Mar 2020
- Results posted
- No
Publications
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.
PubMed 32187469
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery Versus Standardized Non-operative Care for the Treatment of Lumbar Disc Herniations: A Canadian Trial
- ClinicalTrials.gov ID
- NCT01335646
- Acronym / sponsor ID
- UWO16000
- Conditions
- Lumbar Spine Disc Herniation, Lumbar Radiculopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- The London Spine CentreUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Study start
- 21 Mar 2010 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 14 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery | Active comparator | Procedure: Lumbar Microdiscectomy |
| Non-operative | Active comparator | Other: Physiotherapy, Epidural injections, Education, Pain Medications, Anti-inflammatories |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 18 - 60 years old
- Unilateral, single L5 or S1 radiculopathy (leg pain following dermatomal distribution of L5 or S1)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbar Microdiscectomylumbar discectomy within 1 month of randomization | Procedure or surgery | Surgery |
| Physiotherapy, Epidural injections, Education, Pain Medications, Anti-inflammatoriesPhysiotherapy 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 | Other | Non-operative |
Primary outcome
Visual Analogue Scale for leg pain intensity
Time frame: 6 months
(Scale 0-10: 0 = no pain, 10 worst pain)
8 secondary outcomes
Visual Analogue Scale for leg pain intensity
Time frame: enrollment, 6 weeks, 3 months, 6 months, 1 year
Visual Analogue Scale for central back pain intensity
Time frame: enrollment, 6 weeks, 3 months, 6 months, 1 year
Visual Analogue Scale for leg pain frequency
Time frame: enrollment, 6 weeks, 3 months, 6 months, 1 year
Visual Analogue Scale for central back pain frequency
Time frame: enrollment, 6 weeks, 3 months, 6 months, 1 year
Oswestry Disability Index
Time frame: enrollment, 6 weeks, 3 months, 6 months, 1 year
SF36 - Generic Health Outcome Measure
Time frame: enrollment, 6 weeks, 3 months, 6 months, 1 year
Return to Work Status (% of patients employed)
Time frame: enrollment, 6 weeks, 3 months, 6 months, 1 year
Satisfaction with treatment (% of patients satisfied with treatment)
Time frame: 6 weeks, 3 months, 6 months, 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Derived from this study: PubMed 32187469Bailey 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar Microdiscectomy and Physiotherapy, Epidural injections, Education, Pain Medications, Anti-inflammatories in people with Lumbar Spine Disc Herniation and Lumbar Radiculopathy, run by The London Spine Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale for leg pain intensity (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01335646, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.