Chiropractic Distraction Spinal Manipulation- Lumbar Stenosis Study

• Sponsor: Parker University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03863769
• Collaborator: University of Houston (Other), Whittier College (Other), Private Practice (Other), Miami University (Other)
• Enrollment: 14
• Location: 1
• Actual Duration (Months): 21.6
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Stenosis Lumbar	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 Design

• Study Type: Observational
• Actual Enrollment: 14 participants
• Observational Model: Other
• Time Perspective: Other
• Official Title: The Influence of Chiropractic Distraction Spinal Manipulation on Posture and Performance in Patients With Lumbar Spinal Stenosis.
• Actual Study Start Date: Mar 14, 2019
• Actual Primary Completion Date: May 30, 2020
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	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).

Outcome Measures

Primary Outcome Measures

1. 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

1. Questionnaire: Pain sclae [5 Minutes]

   Pain severity of the lower back and buttock using a numerical rating scale (0-10)

2. 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.

3. Questionnaire: Balance [5 Minutes]

   Balance Specific Confidence (ABC-6)

4. 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.

5. Sit to Stand [5 Minutes]

   physical performance as assessed by the 5 Times Sit to Stand and Timed Up and Go tests.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 48 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Parker University	Dallas	Texas	United States	75229

Sponsors and Collaborators

• Parker University
• University of Houston
• Whittier College
• Private Practice
• Miami University

Investigators

• Principal Investigator: Katie Pohlman, DC, MS, PhD, Parker University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Parker University
• ClinicalTrials.gov Identifier: NCT03863769
• Other Study ID Numbers: Parker19_02
• First Posted: Mar 5, 2019
• Last Update Posted: Jan 14, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Keywords provided by Parker University: Chiropractic manipulation; postural sway; distraction manipulation; performance-based mobility
• Additional relevant MeSH terms: Spinal Stenosis; Constriction, Pathologic

Study Results

No Results Posted as of Jan 14, 2022