Lumbar Spinal StenosisPhase 2NCT00527527
Chiropractic Dosage for Lumbar Stenosis
A Phase 2 study testing flexion distraction in people with Lumbar Spinal Stenosis, run by National University of Health Sciences at 1 site in United States.
Trial summary
This randomized clinical trial pilot study will investigate the efficacy of different amounts of total treatment dosage over six weeks in 60 volunteer subjects with lumbar spinal stenosis. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- flexion distraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Jan 2010
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females at least 50 years old with lumbar spinal stenosis
- Impingement of the cord and/or exiting nerve roots evidenced on spine imaging studies
- Symptomatic with current pain in the back and/or one or both of the legs.
- Symptoms must have been present for at least six months with an insidious onset
Who cannot join
- Congenital stenosis or other spine deformities such as current spinal fractures, spinal infections, or tumors of the spine
- Prior lumbar spine surgery such as laminectomy, spinal fusion, or discectomy that lacks stability or occurred within the past 3 months.
- Currently pregnant or nursing
- Co-morbid conditions that may preclude a person from participating in active care (laying prone on a treatment table or completing exercises) and outcome measures (Treadmill Testing, completion of questionnaires), such as severe cardiopulmonary disorders (i.e.: severe coronary artery disease, recent myocardial infarction, or vascular claudication), neuromusculoskeletal disorders (i.e.: disabling hip or knee arthritis; trochanteric bursitis; piriformis syndrome; need for assisted ambulation), or brain disorders (i.e.: dementia or Alzheimer's Disease)
- Active conservative care such as physical therapy or chiropractic care for lumbar stenosis (excluding the use of oral medications or daily at-home exercises for general well-being)
- Cauda equina symptoms (i.e.: perianal numbness; loss of bowel and/or bladder control)
- Not fluent or literate in the English language. We will not be able to provide multiple translators within this pilot study
- Current or future litigation for low back or leg pain
Trial locations and contacts
1 site in 1 country.
United States1 site
National University of Health Sciences
Lombard, Illinois, 60148
About this study
This randomized clinical trial pilot study will investigate the efficacy of different amounts of total treatment dosage over six weeks in 60 volunteer subjects with lumbar spinal stenosis. Subjects will be evenly randomized into four groups of either flexion distraction (FD) care or a control: Group 1 with 8 total FD treatment visits, Group 2 with 12 total FD treatment visits, Group 3 with 18 total FD treatment visits, or Group 4 with 8 total placebo control visits. The study is designed: (1) To determine the feasibility of a larger scale study in terms of logistics, recruitment efforts, and sample size estimations and (2) To determine among the three treatment groups the change in perceived pain levels and general functional health status at the end of six weeks of treatment and at three months post care as follow-up.
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- flexion distraction, placebo control
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flexion distractionProcedure or surgery
Chiropractic treatment using the flexion distraction apparatus
placebo controlOther
Placebo for comparison with flexion distraction treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 8 flexion distraction visits Receives: Procedure: flexion distraction |
| 2 | Active comparator | 12 flexion distraction visits Receives: Procedure: flexion distraction |
| 3 | Active comparator | 18 flexion distraction visits Receives: Procedure: flexion distraction |
| 4 | Placebo comparator | 8 placebo control visits Receives: Other: placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Measured: 6 weeks; 3 and 6 months
Secondary outcomes (1)
Functional health status
Measured: 6 weeks; 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Chiropractic Education and Research (FCER)
- Responsible party
- Principal investigator, Jerrilyn Cambron, DC, PhD, National University of Health Sciences
- Investigators
- Jerrilyn Cambron, DC, PhD, Principal investigator, National University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00527527
- Sponsor's protocol ID
- H0401
- Status last verified
- Oct 2011
- First submitted
- 8 Sep 2007
- Last updated
- 12 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chiropractic Dosage for Lumbar Stenosis
- ClinicalTrials.gov ID
- NCT00527527
- Acronym / sponsor ID
- H0401
- Conditions
- Lumbar Spinal Stenosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National University of Health SciencesUniversity, hospital or other
- Collaborators
- Foundation for Chiropractic Education and Research (FCER)
- Study start
- Sep 2007
- Primary completion
- Jan 2010 (actual)
- First posted
- 11 Sep 2007 (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.
This randomized clinical trial pilot study will investigate the efficacy of different amounts of total treatment dosage over six weeks in 60 volunteer subjects with lumbar spinal stenosis. Subjects will be evenly randomized into four groups of either flexion distraction (FD) care or a control: Group 1 with 8 total FD treatment visits, Group 2 with 12 total FD treatment visits, Group 3 with 18 total FD treatment visits, or Group 4 with 8 total placebo control visits. The study is designed: (1) To determine the feasibility of a larger scale study in terms of logistics, recruitment efforts, and sample size estimations and (2) To determine among the three treatment groups the change in perceived pain levels and general functional health status at the end of six weeks of treatment and at three months post care as follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: flexion distraction8 flexion distraction visits |
| 2 | Active comparator | Procedure: flexion distraction12 flexion distraction visits |
| 3 | Active comparator | Procedure: flexion distraction18 flexion distraction visits |
| 4 | Placebo comparator | Other: placebo control8 placebo control visits |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females at least 50 years old with lumbar spinal stenosis
- Impingement of the cord and/or exiting nerve roots evidenced on spine imaging studies
- Symptomatic with current pain in the back and/or one or both of the legs.
- Symptoms must have been present for at least six months with an insidious onset
Key exclusion criteria (8 listed)
- Congenital stenosis or other spine deformities such as current spinal fractures, spinal infections, or tumors of the spine
- Prior lumbar spine surgery such as laminectomy, spinal fusion, or discectomy that lacks stability or occurred within the past 3 months.
- Currently pregnant or nursing
- Co-morbid conditions that may preclude a person from participating in active care (laying prone on a treatment table or completing exercises) and outcome measures (Treadmill Testing, completion of questionnaires), such as severe cardiopulmonary disorders (i.e.: severe coronary artery disease, recent myocardial infarction, or vascular claudication), neuromusculoskeletal disorders (i.e.: disabling hip or knee arthritis; trochanteric bursitis; piriformis syndrome; need for assisted ambulation), or brain disorders (i.e.: dementia or Alzheimer's Disease)
- Active conservative care such as physical therapy or chiropractic care for lumbar stenosis (excluding the use of oral medications or daily at-home exercises for general well-being)
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 |
|---|---|---|
| flexion distractionChiropractic treatment using the flexion distraction apparatus | Procedure or surgery | 1, 2, 3 |
| placebo controlPlacebo for comparison with flexion distraction treatment | Other | 4 |
Primary outcome
Pain
Time frame: 6 weeks; 3 and 6 months
1 secondary outcome
Functional health status
Time frame: 6 weeks; 3 and 6 months
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 12 Oct 2011.
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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.
Jerrilyn Cambron, DC, PhD principal investigator
National University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing flexion distraction in people with Lumbar Spinal Stenosis, run by National University of Health Sciences at 1 site in United States.
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 8 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 12 Oct 2011. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Pain (time frame: 6 weeks; 3 and 6 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 12 Oct 2011.