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OpenTrials
Completed

NCT Number: NCT00527527

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National University of Health Sciences

Lombard, Illinois, 60148, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

flexion distraction

Procedure

Chiropractic treatment using the flexion distraction apparatus

Placebo control

Other

Placebo for comparison with flexion distraction treatment

Primary outcomes

  1. Pain

    Time frame: 6 weeks; 3 and 6 months

Secondary outcomes

  1. Functional health status

    Time frame: 6 weeks; 3 and 6 months

Sponsors and collaborators

Lead sponsor

National University of Health Sciences

Other

Collaborators

  • Foundation for Chiropractic Education and Research (FCER)

Registry information

Important dates

Study start
2007
Primary completion
2010
First posted
Sep 11, 2007
Registry last updated
Oct 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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