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Using MRI Scans to Evaluate Spinal Manipulation

Primary Purpose

Lower Back Pain

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lumbar side-posture spinal adjusting
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Back Pain focused on measuring Spinal Manipulation, Chiropractic, Zygapophysial Joints

Eligibility Criteria

21 Years - 29 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Student at the National University of Health Sciences 185 pounds or less for males and 145 pounds or less for females No previous history of lower back pain lasting more than 2 weeks, or no more than three episodes of back pain of brief duration (1 to 2 weeks) in any given year Exclusion Criteria: History of lower back pain Presence of disc degeneration, significant osteoarthritis, scoliosis of greater than 20 degrees (Cobb's angle), or other significant pathology seen on x-rays Positive findings on orthopedic or neurologic test Pregnancy Inability of the examining chiropractor to obtain articular releases (audible pop) during lumbar side posture adjustment given at the conclusion of the examination

Sites / Locations

  • National University of Health Sciences

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 9, 2003
Last Updated
August 16, 2006
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00070902
Brief Title
Using MRI Scans to Evaluate Spinal Manipulation
Official Title
The Effects of Positioning and Adjusting on the Z Joint
Study Type
Interventional

2. Study Status

Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
June 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

5. Study Description

Brief Summary
Lumbar spinal manipulation, or chiropractic adjusting, is thought to separate the surfaces of the spinal joints and thereby relieve lower back pain. This study will use MRI scans to evaluate the spinal joints before and after spinal manipulation.
Detailed Description
Zygapophysial joints, better known as facet or "Z" joints, are located on the back (posterior) of the spine on each side of the vertebrae where it overlaps the neighboring vertebrae. Z joints provide stability and allow the spine to bend and twist. Adhesions in the Z joints may develop following hypomobility of vertebrae. These adhesions may be alleviated by separation (gapping) of the Z joints. Side posture adjusting (spinal manipulation) is thought by many to gap the Z joints, yet no measurable differences of the Z joints before and after spinal manipulation have ever been published. This study will evaluate gapping of the L3/L4, L4/L5, and L5/S1 Z joints by taking measurements directly from MRI scans of the Z joints before and during positioning for a side posture adjustment, and before and after side posture adjusting. Health volunteers will be randomly assigned to one of four groups: 1) neutral position followed by side posture positioning (trunk rotated to the volunteer's right); 2) neutral position followed by side posture spinal adjusting followed by neutral positioning; 3) neutral position followed by side posture spinal adjusting, followed by side posture positioning; and 4) neutral position followed by neutral position (control group). MRI scans will be taken with the volunteers in the original neutral position and in the final position (either second neutral position or side posture positioning).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Back Pain
Keywords
Spinal Manipulation, Chiropractic, Zygapophysial Joints

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
64 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Lumbar side-posture spinal adjusting

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Student at the National University of Health Sciences 185 pounds or less for males and 145 pounds or less for females No previous history of lower back pain lasting more than 2 weeks, or no more than three episodes of back pain of brief duration (1 to 2 weeks) in any given year Exclusion Criteria: History of lower back pain Presence of disc degeneration, significant osteoarthritis, scoliosis of greater than 20 degrees (Cobb's angle), or other significant pathology seen on x-rays Positive findings on orthopedic or neurologic test Pregnancy Inability of the examining chiropractor to obtain articular releases (audible pop) during lumbar side posture adjustment given at the conclusion of the examination
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory D. Cramer, DC, PhD
Organizational Affiliation
National University of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University of Health Sciences
City
Lombard
State/Province
Illinois
ZIP/Postal Code
60148
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12435975
Citation
Cramer GD, Gregerson DM, Knudsen JT, Hubbard BB, Ustas LM, Cantu JA. The effects of side-posture positioning and spinal adjusting on the lumbar Z joints: a randomized controlled trial with sixty-four subjects. Spine (Phila Pa 1976). 2002 Nov 15;27(22):2459-66. doi: 10.1097/00007632-200211150-00008.
Results Reference
background
PubMed Identifier
10951308
Citation
Cramer GD, Tuck NR Jr, Knudsen JT, Fonda SD, Schliesser JS, Fournier JT, Patel P. Effects of side-posture positioning and side-posture adjusting on the lumbar zygapophysial joints as evaluated by magnetic resonance imaging: a before and after study with randomization. J Manipulative Physiol Ther. 2000 Jul-Aug;23(6):380-94. doi: 10.1067/mmt.2000.108145.
Results Reference
background
Links:
URL
http://www.nuhs.edu
Description
National University of Health Sciences

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Using MRI Scans to Evaluate Spinal Manipulation

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