SciaticaPhase 2NCT00415220
Manipulation or Microdiscectomy For Sciatica? A Prospective Randomized Controlled Trial.
A Phase 2 study testing Spinal Manipulation, Microdiscectomy in people with Sciatica and Intervertebral Disk Displacement, run by McMorland, Gordon, D.C. at 2 sites in Canada.
Trial summary
The purpose of this study was to compare standardized chiropractic treatment (spinal manipulation) to back surgery (microdiscectomy) for patients with sciatica secondary to lumbar herniated disc refractory to medical management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sciatica, Intervertebral Disk Displacement
- What is being tested?
- Spinal Manipulation, Microdiscectomy
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 2 sitesCanada
- Study dates
- Jan 2000to May 2004
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive patients presenting through elective referral by primary care physicians to one of the three participating spinal neurosurgeons (SC, SJD, RJH) between December 2000 and May 2004 were screened for symptoms of unilateral lumbar radiculopathy secondary to LDH at L3/4, L4/5 or L5/S1. Detailed surgical histories and physical examinations were performed on each referred patient by the consulting neurosurgeon and correlated with evidence of appropriate root compression on MR imaging. Patients who had failed at least 3 months of non-operative management including treatment with analgesics, lifestyle modification, physiotherapy, massage therapy and / or acupuncture, and who were felt appropriate for microdiscectomy by the neurosurgeon were asked to consider study participation.
Who cannot join
- Radicular symptoms < 3 months duration
- Major neurological deficits such as:
- Cauda equina syndrome
- Rapidly progressing neurological symptoms (e.g. foot drop)
- Substance abuse
- Hospitalization for intravenous or intramuscular narcotics
Show all 18Show fewer
- Systemic or visceral disease (e.g. auto-immune diseases, major system failure)
- Hemorrhagic disorders, anticoagulation therapy
- Previous surgery at symptomatic level
- Concurrent chiropractic care at time of enrollment
- Prolonged use of systemic corticosteroids
- Osteopenia/Osteoporosis
- Spondylolisthesis grade III or IV
- Unable to read or speak English
- Age < 18
- Pregnancy
- Dementia or other cognitive impairment
- Unavailable for follow-up (geographic barriers)
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
National Spine Care
Calgary, Alberta, T2N 2A1
University of Calgary, Faculty of Medicine, Division of Neurosurgery
Calgary, Alberta, T2N 4N1
About this study
Official title: Comparison of Treatment Outcomes Between Chiropractic and Back Surgery for the Treatment of Sciatica Secondary to Lumbar Herniated Disc: A Prospective Randomized Controlled Trial.
The purpose of this study was to compare standardized chiropractic treatment (spinal manipulation) to back surgery (microdiscectomy) for patients with sciatica secondary to lumbar herniated disc refractory to medical management.
Read the detailed description
Context: Operative management of lumbar radiculopathy caused by lumbar disc herniation (LDH) in patients refractory to medical management provides rapid and effective symptom relief. However, both short and long term benefits of surgery continue to be scrutinized.
Objective: To compare clinical efficacy of Chiropractic Treatment against Microdiscectomy in patients suffering from sciatica secondary to LDH.
Study Design: Prospective Randomized Controlled Clinical Trial allowing crossover, recruitment 2000-2004, 1 year follow-up.
Setting: Elective primary care physician referrals made directly to neurosurgical spine surgeons at the Foothills Hospital and Medical Centre, University of Calgary.
Patients: Forty consecutive consenting patients with sciatica from LDH refractory to at least three months of non-operative care and found appropriate for surgery.
Interventions: Surgical microdiscectomy or standardized chiropractic treatment. Crossover to the alternate treatment allowed after 3 months.
Main Outcome Measures: McGill Pain Score, Roland Morris Disability Index, Aberdeen Pain Scale, and SF-36 General Health Survey before treatment initiation and after 3, 6, 12, 24 and 52 weeks.
- Conditions
- Sciatica, Intervertebral Disk Displacement
- Being tested
- Spinal Manipulation, Microdiscectomy
- Keywords
- Chiropractic, Manipulation, Back surgery, Herniated lumbar disc, Sciatica, Lumbar microdiscectomy, Cost-effectiveness
- Medical subject headings
- Sciatica, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Manipulation, MicrodiscectomyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
McGill Pain Score
Roland Morris Disability Index
Aberdeen Pain Scale
SF-36 General Health Survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2006 (estimated)
- Study startJan 2000
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SciaticaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- McMorland, Gordon, D.C.
- Collaborators
- Foundation for Chiropractic Education and Research (FCER)
- Investigators
- Gordon McMorland, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00415220
- Sponsor's protocol ID
- FCER-99-10-04[99-03-03r]
- Status last verified
- Dec 2006
- First submitted
- 21 Dec 2006
- Last updated
- 22 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Treatment Outcomes Between Chiropractic and Back Surgery for the Treatment of Sciatica Secondary to Lumbar Herniated Disc: A Prospective Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT00415220
- Acronym / sponsor ID
- FCER-99-10-04[99-03-03r]
- Conditions
- Sciatica, Intervertebral Disk Displacement
- Keywords
- Chiropractic, Manipulation, Back surgery, Herniated lumbar disc, Sciatica, Lumbar microdiscectomy, Cost-effectiveness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- McMorland, Gordon, D.C.
- Collaborators
- Foundation for Chiropractic Education and Research (FCER)
- Study start
- Jan 2000
- Study completion
- May 2004
- First posted
- 22 Dec 2006 (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 purpose of this study was to compare standardized chiropractic treatment (spinal manipulation) to back surgery (microdiscectomy) for patients with sciatica secondary to lumbar herniated disc refractory to medical management.
Detailed description
Context: Operative management of lumbar radiculopathy caused by lumbar disc herniation (LDH) in patients refractory to medical management provides rapid and effective symptom relief. However, both short and long term benefits of surgery continue to be scrutinized.
Objective: To compare clinical efficacy of Chiropractic Treatment against Microdiscectomy in patients suffering from sciatica secondary to LDH.
Study Design: Prospective Randomized Controlled Clinical Trial allowing crossover, recruitment 2000-2004, 1 year follow-up.
Setting: Elective primary care physician referrals made directly to neurosurgical spine surgeons at the Foothills Hospital and Medical Centre, University of Calgary.
Patients: Forty consecutive consenting patients with sciatica from LDH refractory to at least three months of non-operative care and found appropriate for surgery.
Interventions: Surgical microdiscectomy or standardized chiropractic treatment. Crossover to the alternate treatment allowed after 3 months.
Main Outcome Measures: McGill Pain Score, Roland Morris Disability Index, Aberdeen Pain Scale, and SF-36 General Health Survey before treatment initiation and after 3, 6, 12, 24 and 52 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive patients presenting through elective referral by primary care physicians to one of the three participating spinal neurosurgeons (SC, SJD, RJH) between December 2000 and May 2004 were screened for symptoms of unilateral lumbar radiculopathy secondary to LDH at L3/4, L4/5 or L5/S1. Detailed surgical histories and physical examinations were performed on each referred patient by the consulting neurosurgeon and correlated with evidence of appropriate root compression on MR imaging. Patients who had failed at least 3 months of non-operative management including treatment with analgesics, lifestyle modification, physiotherapy, massage therapy and / or acupuncture, and who were felt appropriate for microdiscectomy by the neurosurgeon were asked to consider study participation.
Key exclusion criteria (18 listed)
- Radicular symptoms < 3 months duration
- Major neurological deficits such as:
- Substance abuse
- Hospitalization for intravenous or intramuscular narcotics
- Systemic or visceral disease (e.g. auto-immune diseases, major system failure)
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 |
|---|---|---|
| Spinal Manipulation, Microdiscectomy | Procedure or surgery | – |
Primary outcome
McGill Pain Score
Roland Morris Disability Index
Aberdeen Pain Scale
SF-36 General Health Survey
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 22 Dec 2006.
Related trials for Sciatica
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
RecruitingPhase 1
Study to Evaluate Safety of C-1101 Versus Sterile Saline in Adults With Chronic Painful Lumbosacral Radiculopathy
Lumbosacral Radicular Pain, Sciatic Radiculopathy
Recruiting
Effect of Sensorimotor Training on Pain and Gait Performance in Patients With Discogenic Sciatica
Sciatica Due to Intervertebral Disc Disorder
Not yet recruiting
Randomized Evaluation of Lumbar Injection Effectiveness and Function
Lumbar Radiculopathy, Lumbar Disc Herniation
Recruiting
Effect of Transfer of Energy Capacitive and Resistive on Chronic Discogenic Sciatica
Lumbar Radiculopathy
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.
Gordon McMorland principal investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Spinal Manipulation, Microdiscectomy in people with Sciatica and Intervertebral Disk Displacement, run by McMorland, Gordon, D.C. at 2 sites 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 1 inclusion and 18 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 22 Dec 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
McGill Pain Score. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Dec 2006.