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Chiropractic Dosage for Lumbar Stenosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00527527
Recruitment Status : Completed
First Posted : September 11, 2007
Last Update Posted : October 12, 2011
Sponsor:
Collaborator:
Foundation for Chiropractic Education and Research (FCER)
Information provided by (Responsible Party):
Jerrilyn Cambron, DC, PhD, National University of Health Sciences

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Lumbar Spinal Stenosis Procedure: flexion distraction Other: placebo control Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chiropractic Dosage for Lumbar Stenosis
Study Start Date : September 2007
Actual Primary Completion Date : January 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Pain [ Time Frame: 6 weeks; 3 and 6 months ]

Secondary Outcome Measures :
  1. Functional health status [ Time Frame: 6 weeks; 3 and 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00527527


Locations
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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
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Principal Investigator: Jerrilyn Cambron, DC, PhD National University of Health Sciences
More Information
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Responsible Party: Jerrilyn Cambron, DC, PhD, Researcher and Professor in the Dept of Research, National University of Health Sciences
ClinicalTrials.gov Identifier: NCT00527527    
Other Study ID Numbers: H0401
First Posted: September 11, 2007    Key Record Dates
Last Update Posted: October 12, 2011
Last Verified: October 2011
Additional relevant MeSH terms:
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Spinal Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
 Spinal Diseases
Bone Diseases
Musculoskeletal Diseases