Chiropractic Dosage for Lumbar Stenosis

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 Overview

• Status: Completed
• Conditions: Lumbar Spinal Stenosis
• Intervention / Treatment: Procedure: flexion distraction; Other: placebo control

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Lombard, Illinois, United States, 60148
      • National University of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain	6 weeks; 3 and 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Functional health status	6 weeks; 3 and 6 months

Collaborators and Investigators

• Sponsor: National University of Health Sciences
• Collaborators: Foundation for Chiropractic Education and Research (FCER)
• Investigators: Principal Investigator: Jerrilyn Cambron, DC, PhD, National University of Health Sciences

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: September 8, 2007
• First Submitted That Met QC Criteria: September 8, 2007
• First Posted (Estimate): September 11, 2007

Study Record Updates

• Last Update Posted (Estimate): October 12, 2011
• Last Update Submitted That Met QC Criteria: October 7, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Constriction, Pathologic; Spinal Stenosis
• Other Study ID Numbers: H0401