Chiropractic Distraction Spinal Manipulation- Lumbar Stenosis Study

Completed

• Conditions: Spinal Stenosis Lumbar
• Interventions: Other: Lumbar Spinal Stenosis

• Registration Number: NCT03863769
• Lead Sponsor: Parker University

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.

Study Timeline

• Study First Submitted: 2019-02-14
• Study First Submitted QC: 2019-03-04
• Study First Posted: 2019-03-05
• Study Start: 2019-03-14
• Primary Completion: 2020-05-30
• Study Completion: 2020-12-31
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-28
• Last Update Posted: 2022-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lumbar Spinal Stenosis	Lumbar Spinal Stenosis	Questionnaire, chiropractic treatment, and posture and performance testing.

Primary Outcome Measures

Name	Time	Method
Balance tracking	Each participant will be tested for one minute	The primary outcome is static balance as assessed by center of pressure (COP) using a portable force plate (Balance Tracking Systems, BTrackS™).

Secondary Outcome Measures

Name	Time	Method
Questionnaire: Balance	5 Minutes	Balance Specific Confidence (ABC-6)
Sit to Stand	5 Minutes	physical performance as assessed by the 5 Times Sit to Stand and Timed Up and Go tests.
Questionnaire: Disability	5 Minutes	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.
Questionnaire: Change	5 Minutes	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.
Questionnaire: Pain sclae	5 Minutes	Pain severity of the lower back and buttock using a numerical rating scale (0-10)

Trial Locations

Locations (1)

Parker University; 🇺🇸 Dallas, Texas, United States