Clinical trial NCT03863769: Chiropractic Distraction Spinal Manipulation- Lumbar Stenosis Study
Official title: The Influence of Chiropractic Distraction Spinal Manipulation on Posture and Performance in Patients With Lumbar Spinal Stenosis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Stenosis Lumbar
Keywords: Chiropractic manipulation
postural sway
distraction manipulation
performance-based mobility
Lead sponsor: Parker University
Sponsor class: OTHER
Collaborators: name: University of Houston
name: Whittier College
name: Private Practice
name: Miami University
First posted: 2019-03-05
Enrollment: 14
Sex: ALL
Minimum age (years): 48
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population studied will be existing and/or new patients at the Cox Certified Doctor's private practice.

Brief summary: To assess the effect of chiropractic distraction manipulation on postural sway and simple measures of performance in patients with the clinical diagnosis of lumbar spinal stenosis.

Detailed description: This study aims to assess the effect of chiropractic distraction manipulation in reducing postural sway and improving performance-based mobility and disability in patients with the clinical diagnosis of lumbar spinal stenosis. This study will identify if distraction spinal manipulation will reduce postural sway center of pressure (COP) movements as determined by a force plate, if distraction spinal manipulation will improve simple measures of performance-based mobility and if distraction spinal manipulation will improve perception of balance confidence and will reduce self-rated stenosis associated disability.

Eligibility criteria: Inclusion Criteria:

* Age greater than 48 years old
* Patient has leg or buttock pain while walking
* Patient feels relief of symptoms with bending (flexing) forward
* Patient feels relief when using a shopping cart of bicycle
* Patient has motor or sensory disturbance while walking
* Patient has normal and symmetrical foot pulses
* Patient has lower extremity weakness
* Patient has low back pain
* Duration of symptoms and signs for more than 1 month
* Able to stand and walk without assistive devices for at least 20 minutes
* Able to give written informed consent and complete interviews and questionnaires in English

Exclusion Criteria:

* Complicated spinal pain due to fracture, tumor, infection, or severe spondyloarthropathy
* Has other severe co-morbidities, including progressive neurological deficit
* Other serious pathologies of the locomotor system
* No correspondence availability through email
* Inability to read/ comprehend English
* Compensation or seeking compensation from a third-party liability or workers' compensation
* Previous spinal manipulation within the past month

Primary outcomes:
measure: Balance tracking
timeFrame: Each participant will be tested for one minute
Secondary outcomes:
measure: Questionnaire: Pain sclae
timeFrame: 5 Minutes
measure: Questionnaire: Disability
timeFrame: 5 Minutes
measure: Questionnaire: Balance
timeFrame: 5 Minutes
measure: Questionnaire: Change
timeFrame: 5 Minutes
measure: Sit to Stand
timeFrame: 5 Minutes
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parker University
state: Texas
Study officials:
affiliation: Parker University
name: Katie Pohlman, DC, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References: