Chiropractic Distraction Spinal Manipulation- Lumbar Stenosis Study

Spinal Stenosis Lumbar Clinical Trial

— Stenosis  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03863769
• Other study ID #: Parker19_02
• Status: Completed
• Start date: March 14, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: December 2021
• Source: Parker University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 31, 2020
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 48 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Spinal Stenosis
• Spinal Stenosis Lumbar

Intervention

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).

Locations

Country	Name	City	State
United States	Parker University	Dallas	Texas

Sponsors (5)

Lead Sponsor	Collaborator
Parker University	Miami University, Private Practice, University of Houston, Whittier College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Questionnaire: Pain sclae	Pain severity of the lower back and buttock using a numerical rating scale (0-10)	5 Minutes
Secondary	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
Secondary	Questionnaire: Balance	Balance Specific Confidence (ABC-6)	5 Minutes
Secondary	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
Secondary	Sit to Stand	physical performance as assessed by the 5 Times Sit to Stand and Timed Up and Go tests.	5 Minutes