Chiropractic Distraction Spinal Manipulation- Lumbar Stenosis Study

NCT03863769 | Completed

• 1 other identifier: Parker19_02
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Stenosis Lumbar

Keywords

Chiropractic manipulation; postural sway; distraction manipulation; performance-based mobility

Outcome Measures

Primary Outcomes (1)

• Balance tracking

  The primary outcome is static balance as assessed by center of pressure (COP) using a portable force plate (Balance Tracking Systems, BTrackS™).

  Each participant will be tested for one minute

Secondary Outcomes (5)

• Questionnaire: Pain sclae

  5 Minutes

• Questionnaire: Disability

  5 Minutes

• Questionnaire: Balance

  5 Minutes

• Questionnaire: Change

  5 Minutes

• Sit to Stand

  5 Minutes

Study Arms (1)

Lumbar Spinal Stenosis

Questionnaire, chiropractic treatment, and posture and performance testing.

Other: Lumbar Spinal Stenosis

Interventions

Lumbar Spinal Stenosis OTHER

Posture and Performance testing: ABC-6 Scale, low back pain NRS, buttock or leg pain NRS, five times sit-to-stand, timed up-and-go, PGIC, eyes open force plate assessment (30 seconds), and eyes closed force plate assessment (30 seconds).

Lumbar Spinal Stenosis

Eligibility Criteria

• Age: 48 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Parker University: lead
• University of Houston: collaborator
• Whittier College: collaborator
• Private Practice: collaborator
• Miami University: collaborator

Study Sites (1)

Parker University

Dallas, Texas, 75229, United States

Location

Study Officials

• Katie Pohlman, DC, MS, PhD

  Parker University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: March 5, 2019
• Study Start: March 14, 2019
• Primary Completion: May 30, 2020
• Study Completion: December 31, 2020
• Last Updated: January 14, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

US (1)