Chiropractic Dosage for Lumbar Stenosis

This study has been completed.
Sponsor:
Collaborator:
Foundation for Chiropractic Education and Research (FCER)
Information provided by (Responsible Party):
Jerrilyn Cambron, DC, PhD, National University of Health Sciences
ClinicalTrials.gov Identifier:
NCT00527527
First received: September 8, 2007
Last updated: October 7, 2011
Last verified: October 2011
  Purpose

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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chiropractic Dosage for Lumbar Stenosis

Resource links provided by NLM:


Further study details as provided by National University of Health Sciences:

Primary Outcome Measures:
  • Pain [ Time Frame: 6 weeks; 3 and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional health status [ Time Frame: 6 weeks; 3 and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2007
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00527527

Locations
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
Principal Investigator: Jerrilyn Cambron, DC, PhD National University of Health Sciences
  More Information

No publications provided

Responsible Party: Jerrilyn Cambron, DC, PhD, Researcher and Professor in the Dept of Research, National University of Health Sciences
ClinicalTrials.gov Identifier: NCT00527527     History of Changes
Other Study ID Numbers: H0401
Study First Received: September 8, 2007
Last Updated: October 7, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Constriction, Pathologic
Spinal Stenosis
Bone Diseases
Musculoskeletal Diseases
Pathological Conditions, Anatomical
Spinal Diseases

ClinicalTrials.gov processed this record on October 23, 2014