Chiropractic Dosage for Lumbar Stenosis
This study has been completed.
Sponsor:
National University of Health Sciences
Collaborator:
Foundation for Chiropractic Education and Research (FCER)
Information provided by (Responsible Party):
Jerrilyn Cambron, DC, PhD, National University of Health Sciences
ClinicalTrials.gov Identifier:
NCT00527527
First received: September 8, 2007
Last updated: October 7, 2011
Last verified: October 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lumbar Spinal Stenosis |
Procedure: flexion distraction Other: placebo control |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Chiropractic Dosage for Lumbar Stenosis |
Resource links provided by NLM:
Further study details as provided by National University of Health Sciences:
Primary Outcome Measures:
- Pain [ Time Frame: 6 weeks; 3 and 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Functional health status [ Time Frame: 6 weeks; 3 and 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2007 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
8 flexion distraction visits
|
Procedure: flexion distraction
Chiropractic treatment using the flexion distraction apparatus
|
|
Active Comparator: 2
12 flexion distraction visits
|
Procedure: flexion distraction
Chiropractic treatment using the flexion distraction apparatus
|
|
Active Comparator: 3
18 flexion distraction visits
|
Procedure: flexion distraction
Chiropractic treatment using the flexion distraction apparatus
|
|
Placebo Comparator: 4
8 placebo control visits
|
Other: placebo control
Placebo for comparison with flexion distraction treatment
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00527527
Locations
| United States, Illinois | |
| National University of Health Sciences | |
| Lombard, Illinois, United States, 60148 | |
Sponsors and Collaborators
National University of Health Sciences
Foundation for Chiropractic Education and Research (FCER)
Investigators
| Principal Investigator: | Jerrilyn Cambron, DC, PhD | National University of Health Sciences |
More Information
No publications provided
| Responsible Party: | Jerrilyn Cambron, DC, PhD, Researcher and Professor in the Dept of Research, National University of Health Sciences |
| ClinicalTrials.gov Identifier: | NCT00527527 History of Changes |
| Other Study ID Numbers: | H0401 |
| Study First Received: | September 8, 2007 |
| Last Updated: | October 7, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Constriction, Pathologic Spinal Stenosis Pathological Conditions, Anatomical |
Spinal Diseases Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 23, 2013