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Chiropractic Dosage for Lumbar Stenosis

Primary Purpose

Lumbar Spinal Stenosis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

flexion distraction

placebo control

About this trial

This is an interventional treatment trial for Lumbar Spinal Stenosis

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

National University of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

8 flexion distraction visits

12 flexion distraction visits

18 flexion distraction visits

8 placebo control visits

Outcomes

Primary Outcome Measures

Pain

Secondary Outcome Measures

Functional health status

Full Information

NCT ID

NCT00527527

First Posted

September 8, 2007

Last Updated

October 7, 2011

Sponsor

National University of Health Sciences

Collaborators

Foundation for Chiropractic Education and Research (FCER)

1. Study Identification

Unique Protocol Identification Number

NCT00527527

Brief Title

Chiropractic Dosage for Lumbar Stenosis

Official Title

Chiropractic Dosage for Lumbar Stenosis

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

January 2010 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National University of Health Sciences

Collaborators

Foundation for Chiropractic Education and Research (FCER)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lumbar Spinal Stenosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

8 flexion distraction visits

Arm Title

Arm Type

Active Comparator

Arm Description

12 flexion distraction visits

Arm Title

Arm Type

Active Comparator

Arm Description

18 flexion distraction visits

Arm Title

Arm Type

Placebo Comparator

Arm Description

8 placebo control visits

Intervention Type

Procedure

Intervention Name(s)

flexion distraction

Intervention Description

Chiropractic treatment using the flexion distraction apparatus

Intervention Type

Other

Intervention Name(s)

placebo control

Intervention Description

Placebo for comparison with flexion distraction treatment

Primary Outcome Measure Information:

Title

Pain

Time Frame

6 weeks; 3 and 6 months

Secondary Outcome Measure Information:

Title

Functional health status

Time Frame

6 weeks; 3 and 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jerrilyn Cambron, DC, PhD

Organizational Affiliation

National University of Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

National University of Health Sciences

City

Lombard

State/Province

Illinois

ZIP/Postal Code

60148

Country

United States

12. IPD Sharing Statement

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Chiropractic Dosage for Lumbar Stenosis

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