Chiropractic Dosage for Lumbar Stenosis

Lumbar Spinal Stenosis Clinical Trial

Official title:

Chiropractic Dosage for Lumbar Stenosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00527527
• Other study ID #: H0401
• Status: Completed
• Phase: Phase 2
• First received: September 8, 2007
• Last updated: October 7, 2011
• Start date: September 2007

Study information

• Verified date: October 2011
• Source: National University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

Procedure:
• flexion distraction
Chiropractic treatment using the flexion distraction apparatus

Other:
• placebo control
Placebo for comparison with flexion distraction treatment

Locations

Country	Name	City	State
United States	National University of Health Sciences	Lombard	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
National University of Health Sciences	Foundation for Chiropractic Education and Research (FCER)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain		6 weeks; 3 and 6 months	No
Secondary	Functional health status		6 weeks; 3 and 6 months	No