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Sponsors and Collaborators: |
National University of Health Sciences Foundation for Chiropractic Education and Research |
Information provided by: | National University of Health Sciences |
ClinicalTrials.gov Identifier: | NCT00527527 |
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 II |
MedlinePlus related topics: | Spinal Stenosis |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Chiropractic Dosage for Lumbar Stenosis |
Estimated Enrollment: | 60 |
Study Start Date: | September 2007 |
Arms | Assigned Interventions |
1: Active Comparator
8 flexion distraction visits
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Procedure: flexion distraction |
2: Active Comparator
12 flexion distraction visits
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Procedure: flexion distraction |
3: Active Comparator
18 flexion distraction visits
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Procedure: flexion distraction |
4: Placebo Comparator
8 placebo control visits
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Other: placebo control |
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jerrilyn Cambron, DC, PhD | jcambron@nuhs.edu | |
Contact: Gregory Cramer, DC, PhD | gcramer@nuhs.edu |
United States, Illinois | |||||
National University of Health Sciences | Recruiting | ||||
Lombard, Illinois, United States, 60148 | |||||
Contact: Jerrilyn Cambron, DC, PhD jcambron@nuhs.edu | |||||
Principal Investigator: Jerrilyn Cambron, DC, PhD | |||||
Sub-Investigator: James Jedlicka, DC | |||||
Sub-Investigator: Gregory Cramer, DC, PhD | |||||
Sub-Investigator: Grant Iannelli, DC |
National University of Health Sciences |
Foundation for Chiropractic Education and Research |
Principal Investigator: | Jerrilyn Cambron, DC, PhD | National University of Health Sciences |
Study ID Numbers: | H0401 |
First Received: | September 8, 2007 |
Last Updated: | September 8, 2007 |
ClinicalTrials.gov Identifier: | NCT00527527 |
Health Authority: | United States: Institutional Review Board |
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