title: A pilot randomized controlled trial of flexion-distraction dosage for chiropractic treatment of lumbar spinal stenosis.
abstract: OBJECTIVE
  The purpose of this pilot clinical trial was to assess the feasibility of recruiting older adults with lumbar spinal stenosis (LSS) into a clinical trial that used different dosages of flexion-distraction manipulation.
  
  
  METHODS
  This randomized controlled trial used a 4-group design. Three groups consisted of chiropractic flexion-distraction manipulation applied at different dosages (8, 12, or 18 treatments). The fourth group was given 8 treatments of placebo care. Feasibility measures included recruitment goals, adherence to various treatment schedules, credibility of the placebo treatment, and rates of adverse events. The primary outcome measure was the Swiss Spinal Stenosis Questionnaire, a validated self-report of LSS symptom severity and physical function.
  
  
  RESULTS
  The recruitment and adherence goals of the study were met with a total of 60 subjects randomized (n = 15 per group) and most subjects attending at least 75% of their scheduled visits. No adverse events were reported by any of the subjects in the trial. Our placebo treatment did not appear to be credible; most subjects correctly guessed that they were receiving a placebo treatment. Between-group effect size estimates were small, indicating larger samples are needed for future studies.
  
  
  CONCLUSIONS
  This pilot study showed that it is feasible to recruit patients with LSS and that most subjects will adhere to a 6-week treatment schedule. The information gained from this trial will be useful to inform the design of larger trials.
authors.affiliation: Professor, Department of Research, National University of Health Sciences, Lombard, IL. Electronic address: jcambron@nuhs.edu.
authors.forename: Jerrilyn A
authors.initials: JA
authors.lastname: Cambron
authors.affiliation: Assistant Professor, Department of Physical Therapy, University of Pittsburgh, Pittsburgh, PA.
authors.forename: Michael
authors.initials: M
authors.lastname: Schneider
authors.affiliation: Clinical Research Coordinator, Department of Research, National University of Health Sciences, Lombard, IL.
authors.forename: Jennifer M
authors.initials: JM
authors.lastname: Dexheimer
authors.affiliation: Professor of Anatomy and Physiology, ATS Institute of Technology, Chicago, IL.
authors.forename: Grant
authors.initials: G
authors.lastname: Iannelli
authors.affiliation: Assistant Professor, Department of Clinical Sciences, National University of Health Sciences, St. Petersburg, FL.
authors.forename: Mabel
authors.initials: M
authors.lastname: Chang
authors.affiliation: Assistant Professor, Department of Occupational Therapy, University of Pittsburgh, Pittsburgh, PA.
authors.forename: Lauren
authors.initials: L
authors.lastname: Terhorst
authors.affiliation: Dean and Professor, Department of Research, National University of Health Sciences, Lombard, IL.
authors.forename: Gregory D
authors.initials: GD
authors.lastname: Cramer
mesh_terms: D005260:Female; D006801:Humans; D008159:Lumbar Vertebrae; D008297:Male; D026882:Manipulation, Chiropractic / Q000379:methods*; D008875:Middle Aged; D010865:Pilot Projects; D013130:Spinal Stenosis / Q000628:therapy*
keywords: Complementary Therapies; Low Back Pain; Lumbar Vertebrae; Manipulation, Chiropractic; Spinal Stenosis