Z-Joint Changes in Low Back Pain Following Adjusting

NCT00284063 | Completed DMC

• 1 other identifier: 2R01AT000123-03
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this continuation project is to use MRI to evaluate gapping of the zygapophysial (Z) joints following side-posture positioning and side-posture spinal adjusting in subjects with acute low back pain.

Conditions

Mechanical Low Back Pain

Keywords

spinal manipulation, zygapophysial joints

Outcome Measures

Primary Outcomes (1)

• Anterior to posterior measurements (A-P gap) of the Z joints.

  February 2006-December 2011

Secondary Outcomes (2)

• Amount of gapping will be compared to relief of pain (Visual Analog Scale).

  February 2006-January 2010

• Amount of gapping compared to disability (Bournemouth Questionnaire)

  February 2006-January 2009

Study Arms (4)

Group 1: N; SPP; N

ACTIVE COMPARATOR

N = neutral MRI; SP = side posture MRI; SPP = side posture position; SMT = side posture manipulation

Procedure: MRI

Group 2: N; SMT; N

ACTIVE COMPARATOR

N = neutral MRI; SP = side posture MRI; SPP = side posture position; SMT = side posture manipulation

Procedure: Low back adjustment and MRI

Group 3: N; SMT; SP

ACTIVE COMPARATOR

N = neutral MRI; SP = side posture MRI; SPP = side posture position; SMT = side posture manipulation

Procedure: Low back adjustment and MRI

Group 4: N and SP

NO INTERVENTION

N = neutral MRI SP = side posture MRI SPP = side posture position SMT = side posture manipulation

Interventions

Low back adjustment and MRI PROCEDURE

Subjects received a 15 minutes MRI in neutral position, a chiropractic low back spinal manipulation, and a second 15 minute MRI in neutral position.

Also known as: spinal manipulation = spinal adjustment

Group 2: N; SMT; N

MRI PROCEDURE

Subjects received a 15 minute MRI in neutral position and a second 15 minute MRI in neutral position.

Also known as: spinal manipulation = spinal adjustment

Group 1: N; SPP; N

Eligibility Criteria

• Age: 21 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Twenty-one to 69 years of age (21 years to ensure fully developed Z joints and \<70 years to tolerate side posture MRI scans)
• Females equal to or less than 160 pounds; males equal to or less than 200 pounds. Hip width measurement that is equal to or less than 36cm.(to ensure optimum MR image quality)
• Pain related to the low back (lower lumbar region, L4/L5 and/or L5/S1 region -this criterion will be determined by the examining physician through subjective complaint and description, as well as objectively, using inspection, palpation, motion assessment, and standard orthopedic and neurologic tests
• No history of LBP lasting for more than two weeks, or no more than 3 episodes of brief back pain (1 - 2 weeks) in the past year.

You may not qualify if:

• Presence of lumbar scoliosis of greater than 5 degrees (Cobb's angle) (due to difficulty in imaging the Z joints)
• Presence of radiculopathy (This criterion will be evaluated by the examining physician by using patient history, standard screening tests, and the results of a detailed orthopedic/neurologic evaluation).
• No pain related to L4/L5 and/or L5/S1 region (This criterion will be determined by the examining physician through subjective complaint and description, as well as objectively using inspection, palpation, motion assessment, and standard orthopedic tests such as, Kemp's, Milgram's, Yeoman's, straight leg raise, and Valsalva maneuver.)
• Pregnancy or currently breast feeding (for MRI, even though no known risk, and in the event an x-ray is needed to screen for contraindications to manipulation)
• Intolerance to MRI procedures (including claustrophobia and inability to lie on one's side for 15 minutes). This criterion can also be evaluated at any time throughout the first two weeks of a subject's care. Claustrophobia will also be evaluated before and during the first and second MRI scans.
• Significant pathology discovered on MRI scans. This criterion will be evaluated during the first MRI visit, immediately after the first MRI scan is taken. (Such pathologies constitute contraindications to chiropractic adjusting.)
• Absence of acute low back pain

Sponsors & Collaborators

• National University of Health Sciences: lead
• Canadian Memorial Chiropractic College: collaborator
• Auburn University: collaborator

Study Sites (1)

National University of Health Sciences

Lombard, Illinois, 60148, United States

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Magnetic Resonance Spectroscopy; Manipulation, Chiropractic

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics

Study Officials

• Gregory D. Cramer, DC, PhD

  National University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of Research

Study Record Dates

• First Submitted: January 30, 2006
• First Posted: January 31, 2006
• Study Start: January 31, 2006
• Primary Completion: December 1, 2009
• Study Completion: September 30, 2010
• Last Updated: May 12, 2022

Record last verified: 2015-04

Locations

US (1)