Acute SciaticaNCT01552486
Chiropractic Spinal Manipulative Therapy for Acute Sciatica Secondary to Lumbar Disc Herniation
A study testing Chiropractic Spinal Manipulative Therapy in people with Acute Sciatica and Lumbar Disc Herniation, run by Vancouver General Hospital at 1 site in Canada.
Trial summary
Comparisons of surgical and non-operative treatment of patients with acute sciatica secondary to lumbar intervertebral disc herniation (AS/LDH) have shown no appreciable difference in outcome. The composition of the non-operative treatment of this patient population remains poorly defined. Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Acute Sciatica, Lumbar Disc Herniation
- What is being tested?
- Chiropractic Spinal Manipulative Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2012to Jun 2017
- 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 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- chief complaint of sciatica rather than lower back pain
- pain of up to 6 months' duration
- a McCulloch criteria score of 5/5 (two clinical symptoms and two clinical signs of sciatica, and diagnostic imaging confirming the presence of a herniated nucleus pulposus contacting a spinal nerve root at the appropriate level)
- fluency in spoken and written English to ensure subjects understand the content of questionnaires and consent
Who cannot join
- progressive neurological deficit
- spinal fracture
- spinal tumor
- spinal infection
- spinal nerve root motor score of less than 4/5
- spinal stenosis that is not attributable to a herniated disc
- any other significant spinal ailment or local or generalized co-morbidity ailment that could affect outcomes independently of SMT ( e.g. seronegative spondyloarthropathy, malignancy).
Trial locations and contacts
1 site in 1 country.
Canada1 site
Integrated Spine Clinic, Blusson Spinal Cord Centre, Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: Biology and Clinical Outcomes of Chiropractic Spinal Manipulative Therapy in the Treatment of Patients With Acute Inflammatory Radiculopathy Secondary to Lumbar Disc Herniation: a Pilot Study
Comparisons of surgical and non-operative treatment of patients with acute sciatica secondary to lumbar intervertebral disc herniation (AS/LDH) have shown no appreciable difference in outcome. The composition of the non-operative treatment of this patient population remains poorly defined. Spinal manipulative therapy (SMT) has demonstrated value in the treatment of AS/LDH. Recent preliminary studies suggest that SMT provides therapeutic benefit through the modulation of in vivo inflammatory mediators. This feasibility study will define the key experimental variables required to conduct a large multicentre study that will clarify the biological and clinical outcomes of SMT in the treatment of patients with AS/LDH.
- Conditions
- Acute Sciatica, Lumbar Disc Herniation
- Being tested
- Chiropractic Spinal Manipulative Therapy, Usual Care
- Keywords
- chiropractic, manipulation, radiculopathy, sciatica, lumbar, disc, herniation, protrusion
- Medical subject headings
- Intervertebral Disc Displacement, Radiculopathy, Sciatica, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chiropractic Spinal Manipulative TherapyOther
Patients will receive a course high-velocity low-amplitude thrust spinal manipulation 3 times per week for 4 weeks.
Usual CareOther
Patients will be under the care of the their general physician and will be allowed the following medications: gabapentin, pregabalin, nortriptyline, amitriptyline.
| Study group | Role | What they receive |
|---|---|---|
| Chiropractic Spinal Manipulative Therapy | Experimental | Not described Receives: Other: Chiropractic Spinal Manipulative Therapy |
| Usual Care | Other | Not described Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of recruitment of eligible patients
Measured: The number of patients recruited per week for 19 months
Secondary outcomes (9)
Cytokine and cytokine mRNA levels in serum.
Measured: Change from baseline cytokine and cytokine mRNA levels in serum 4 weeks prior to surgery or commencing chiropractic spinal manipulative therapy (CSMT).
Cytokine and cytokine mRNA levels in serum
Measured: Change from baseline cytokine and mRNA levels in serum pre-surgery or following a 4-week course of CSMT.
Cytokine and cytokine mRNA levels in serum
Measured: Change from baseline cytokine and mRNA levels in serum and 12 weeks post-surgery and/or post-CSMT
Cytokine and cytokine mRNA levels in serum.
Measured: Change from baseline cytokine and mRNA levels in serum and 24 weeks post-surgery and/or post-CSMT
Total mRNA levels (isolated from disc tissue and disc / periradicular lavage samples) of interleukins 1,10 and 11, MIP-1 beta TNF alpha, and chemotactic protein alpha.
Measured: Specimens will be harvested an average of 6 weeks post-randomization
Modified Roland Disability Questionnaire (mRDQ) score and Visual Analogue Scale (VAS) pain scale.
Measured: Change from baseline and 4-weeks prior to surgery or commencing 4-weeks of CSMT.
mRDQ and VAS
Measured: Change from baseline and pre-surgery or following a 4-week course of CSMT
mRMQ and VAS
Measured: Change from baseline and 12 weeks post-surgery and/or post-CSMT
mRDQ and VAS
Measured: Change from baseline and 24 weeks post-surgery and/or post-CSMT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vancouver General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Paul Bishop, Vancouver General Hospital
- Investigators
- Paul B Bishop, DC, MD, PhD, Principal investigator, Clinical Associate Professor, I.C.O.R.D. Research Professor, Division of Spine, Department of Orthopaedics, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01552486
- Sponsor's protocol ID
- 1R21AT006773-01A1
- Status last verified
- Nov 2016
- First submitted
- 29 Feb 2012
- Last updated
- 3 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biology and Clinical Outcomes of Chiropractic Spinal Manipulative Therapy in the Treatment of Patients With Acute Inflammatory Radiculopathy Secondary to Lumbar Disc Herniation: a Pilot Study
- ClinicalTrials.gov ID
- NCT01552486
- Acronym / sponsor ID
- 1R21AT006773-01A1
- Conditions
- Acute Sciatica, Lumbar Disc Herniation
- Keywords
- chiropractic, manipulation, radiculopathy, sciatica, lumbar, disc, herniation, protrusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Vancouver General HospitalUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 13 Mar 2012 (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.
Comparisons of surgical and non-operative treatment of patients with acute sciatica secondary to lumbar intervertebral disc herniation (AS/LDH) have shown no appreciable difference in outcome. The composition of the non-operative treatment of this patient population remains poorly defined. Spinal manipulative therapy (SMT) has demonstrated value in the treatment of AS/LDH. Recent preliminary studies suggest that SMT provides therapeutic benefit through the modulation of in vivo inflammatory mediators. This feasibility study will define the key experimental variables required to conduct a large multicentre study that will clarify the biological and clinical outcomes of SMT in the treatment of patients with AS/LDH.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chiropractic Spinal Manipulative Therapy | Experimental | Other: Chiropractic Spinal Manipulative Therapy |
| Usual Care | Other | Other: Usual Care |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- chief complaint of sciatica rather than lower back pain
- pain of up to 6 months' duration
- a McCulloch criteria score of 5/5 (two clinical symptoms and two clinical signs of sciatica, and diagnostic imaging confirming the presence of a herniated nucleus pulposus contacting a spinal nerve root at the appropriate level)
- fluency in spoken and written English to ensure subjects understand the content of questionnaires and consent
Key exclusion criteria (7 listed)
- progressive neurological deficit
- spinal fracture
- spinal tumor
- spinal infection
- spinal nerve root motor score of less than 4/5
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 |
|---|---|---|
| Chiropractic Spinal Manipulative TherapyPatients will receive a course high-velocity low-amplitude thrust spinal manipulation 3 times per week for 4 weeks. | Other | Chiropractic Spinal Manipulative Therapy |
| Usual CarePatients will be under the care of the their general physician and will be allowed the following medications: gabapentin, pregabalin, nortriptyline, amitriptyline. | Other | Usual Care |
Primary outcome
Rate of recruitment of eligible patients
Time frame: The number of patients recruited per week for 19 months
9 secondary outcomes
Cytokine and cytokine mRNA levels in serum.
Time frame: Change from baseline cytokine and cytokine mRNA levels in serum 4 weeks prior to surgery or commencing chiropractic spinal manipulative therapy (CSMT).
Cytokine and cytokine mRNA levels in serum
Time frame: Change from baseline cytokine and mRNA levels in serum pre-surgery or following a 4-week course of CSMT.
Cytokine and cytokine mRNA levels in serum
Time frame: Change from baseline cytokine and mRNA levels in serum and 12 weeks post-surgery and/or post-CSMT
Cytokine and cytokine mRNA levels in serum.
Time frame: Change from baseline cytokine and mRNA levels in serum and 24 weeks post-surgery and/or post-CSMT
Total mRNA levels (isolated from disc tissue and disc / periradicular lavage samples) of interleukins 1,10 and 11, MIP-1 beta TNF alpha, and chemotactic protein alpha.
Time frame: Specimens will be harvested an average of 6 weeks post-randomization
Modified Roland Disability Questionnaire (mRDQ) score and Visual Analogue Scale (VAS) pain scale.
Time frame: Change from baseline and 4-weeks prior to surgery or commencing 4-weeks of CSMT.
mRDQ and VAS
Time frame: Change from baseline and pre-surgery or following a 4-week course of CSMT
mRMQ and VAS
Time frame: Change from baseline and 12 weeks post-surgery and/or post-CSMT
mRDQ and VAS
Time frame: Change from baseline and 24 weeks post-surgery and/or post-CSMT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2016.
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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.
Paul B Bishop, DC, MD, PhD principal investigator
Clinical Associate Professor, I.C.O.R.D. Research Professor, Division of Spine, Department of Orthopaedics, University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chiropractic Spinal Manipulative Therapy in people with Acute Sciatica and Lumbar Disc Herniation, run by Vancouver General Hospital 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 3 Nov 2016. 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?
Results are not available in the source record.
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?
Rate of recruitment of eligible patients (time frame: The number of patients recruited per week for 19 months). 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 3 Nov 2016.