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Chiropractic Dosage for Lumbar Stenosis

NCT ID: NCT00527527

Last Updated: 2011-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Lumbar Spinal Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

8 flexion distraction visits

Group Type ACTIVE_COMPARATOR

flexion distraction

Intervention Type PROCEDURE

Chiropractic treatment using the flexion distraction apparatus

2

12 flexion distraction visits

Group Type ACTIVE_COMPARATOR

flexion distraction

Intervention Type PROCEDURE

Chiropractic treatment using the flexion distraction apparatus

3

18 flexion distraction visits

Group Type ACTIVE_COMPARATOR

flexion distraction

Intervention Type PROCEDURE

Chiropractic treatment using the flexion distraction apparatus

4

8 placebo control visits

Group Type PLACEBO_COMPARATOR

placebo control

Intervention Type OTHER

Placebo for comparison with flexion distraction treatment

Interventions

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flexion distraction

Chiropractic treatment using the flexion distraction apparatus

Intervention Type PROCEDURE

placebo control

Placebo for comparison with flexion distraction treatment

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Foundation for Chiropractic Education and Research (FCER)

OTHER

Sponsor Role collaborator

National University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Jerrilyn Cambron, DC, PhD

Researcher and Professor in the Dept of Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jerrilyn Cambron, DC, PhD

Role: PRINCIPAL_INVESTIGATOR

National University of Health Sciences

Locations

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National University of Health Sciences

Lombard, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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H0401

Identifier Type: -

Identifier Source: org_study_id