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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Chiropractic treatment using the flexion distraction apparatus
Placebo for comparison with flexion distraction treatment
National University of Health Sciences
Lombard, Illinois, United States
Pain
Time frame: 6 weeks; 3 and 6 months
Functional health status
Time frame: 6 weeks; 3 and 6 months
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