Chiropractic Distraction Spinal Manipulation- Lumbar Stenosis Study (Stenosis)

The Influence of Chiropractic Distraction Spinal Manipulation on Posture and Performance in Patients With Lumbar Spinal Stenosis.

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.

Study Overview

• Status: Completed
• Conditions: Spinal Stenosis Lumbar
• Intervention / Treatment: Other: 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.

• Study Type: Observational
• Enrollment (Actual): 14

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75229
      • Parker University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lumbar Spinal Stenosis; Questionnaire, chiropractic treatment, and posture and performance testing.	Other: Lumbar Spinal Stenosis; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire: Pain sclae	Pain severity of the lower back and buttock using a numerical rating scale (0-10)	5 Minutes
Questionnaire: Disability	Stenosis specific disability using the Zurich Claudication Questionnaire; symptom and function. Zurich Claudication Questionnaire has a 7-item symptom severity subscale with scores from 1 to 5 and a 5-item physical function subscale with scores from 1 to 4. The total score range is 12 to 55 points, with higher scores indicating higher levels of self-reported disability.	5 Minutes
Questionnaire: Balance	Balance Specific Confidence (ABC-6)	5 Minutes
Questionnaire: Change	Patient Global Impression of Change, this 1-item question has a 7-point rating scale with 1 being no change and 7 being considerable improvement.	5 Minutes
Sit to Stand	physical performance as assessed by the 5 Times Sit to Stand and Timed Up and Go tests.	5 Minutes

Collaborators and Investigators

• Sponsor: Parker University
• Collaborators: University of Houston; Miami University; Whittier College; Private Practice
• Investigators: Principal Investigator: Katie Pohlman, DC, MS, PhD, Parker University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 14, 2019
• Primary Completion (ACTUAL): May 30, 2020
• Study Completion (ACTUAL): December 31, 2020

Study Registration Dates

• First Submitted: February 14, 2019
• First Submitted That Met QC Criteria: March 4, 2019
• First Posted (ACTUAL): March 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 14, 2022
• Last Update Submitted That Met QC Criteria: December 28, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: postural sway; Chiropractic manipulation; distraction manipulation; performance-based mobility
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Constriction, Pathologic; Spinal Stenosis
• Other Study ID Numbers: Parker19_02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Information about this study and individual data will be made available per request and approval from all investigator members.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No