Chiropractic Dosage for Lumbar Stenosis

NCT00527527 | Completed Phase 2 DMC

• 1 other identifier: H0401
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

• Pain

  6 weeks; 3 and 6 months

Secondary Outcomes (1)

• Functional health status

  6 weeks; 3 and 6 months

Study Arms (4)

1

ACTIVE COMPARATOR

8 flexion distraction visits

Procedure: flexion distraction

2

ACTIVE COMPARATOR

12 flexion distraction visits

Procedure: flexion distraction

3

ACTIVE COMPARATOR

18 flexion distraction visits

Procedure: flexion distraction

4

PLACEBO COMPARATOR

8 placebo control visits

Other: placebo control

Interventions

flexion distraction PROCEDURE

Chiropractic treatment using the flexion distraction apparatus

1; 2; 3

placebo control OTHER

Placebo for comparison with flexion distraction treatment

4

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Health Sciences: lead
• Foundation for Chiropractic Education and Research (FCER): collaborator

Study Sites (1)

National University of Health Sciences

Lombard, Illinois, 60148, United States

Location

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Jerrilyn Cambron, DC, PhD

  National University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher and Professor in the Dept of Research

Study Record Dates

• First Submitted: September 8, 2007
• First Posted: September 11, 2007
• Study Start: September 1, 2007
• Primary Completion: January 1, 2010
• Last Updated: October 12, 2011

Record last verified: 2011-10

Locations

US (1)