Z-Joint Changes in Low Back Pain Following Adjusting

This study has been completed.
Sponsor:
Collaborators:
Canadian Memorial Chiropractic College
Auburn University
Information provided by (Responsible Party):
Gregory D. Cramer, National University of Health Sciences
ClinicalTrials.gov Identifier:
NCT00284063
First received: January 30, 2006
Last updated: May 1, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Mechanical Low Back Pain
Procedure: No intervention, only MRI
Procedure: Low back adjustment and MRI
Procedure: MRI

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Z-Joint Changes in Low Back Pain Following Adjusting

Resource links provided by NLM:


Further study details as provided by National University of Health Sciences:

Primary Outcome Measures:
  • Anterior to posterior measurements (A-P gap) of the Z joints. [ Time Frame: February 2006-December 2011 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Amount of gapping will be compared to relief of pain (Visual Analog Scale). [ Time Frame: February 2006-January 2010 ] [ Designated as safety issue: No ]
  • Amount of gapping compared to disability (Bournemouth Questionnaire) [ Time Frame: February 2006-January 2009 ] [ Designated as safety issue: No ]

Enrollment: 112
Study Start Date: October 2005
Study Completion Date: September 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1: N; SPP; N
N = neutral MRI; SP = side posture MRI; SPP = side posture position; SMT = side posture manipulation
Procedure: MRI
Subjects received a 15 minute MRI in neutral position and a second 15 minute MRI in neutral position.
Other Name: spinal manipulation = spinal adjustment
Active Comparator: Group 2: N; SMT; N
N = neutral MRI; SP = side posture MRI; SPP = side posture position; SMT = side posture manipulation
Procedure: Low back adjustment and MRI
Subjects received a 15 minutes MRI in neutral position, a chiropractic low back spinal manipulation, and a second 15 minute MRI in neutral position.
Other Name: spinal manipulation = spinal adjustment
Active Comparator: Group 3: N; SMT; SP
N = neutral MRI; SP = side posture MRI; SPP = side posture position; SMT = side posture manipulation
Procedure: Low back adjustment and MRI
Subjects received a 15 minutes MRI in neutral position, a chiropractic spinal manipulation to the low back, and a second 15 minute MRI in a side posture position.
Other Name: spinal manipulation = spinal adjustment
No Intervention: Group 4: N and SP
N = neutral MRI SP = side posture MRI SPP = side posture position SMT = side posture manipulation
Procedure: No intervention, only MRI
Subjects received an initial 15 minute MRI in neutral position and a second 15 minute MRI in side posture position.
Other Name: spinal manipulation = spinal adjustment

Detailed Description:

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 (LBP). A fundamental hypothesis of one of the beneficial effects of chiropractic spinal adjusting is that adhesions, developing in the Z joints following hypomobility of these structures, are thought to be alleviated by separation (gapping) of the Z joints through spinal adjusting. In the previous study, side-posture adjusting was found to gap the Z joints in healthy subjects. The aim of this study is to determine if differences can be measured in the L4/L5 and L5/S1 Z joint spaces during side-posture positioning and after lumbar side-posture spinal adjusting of 112 subjects with acute LBP, and to determine if the amount of gapping is related to pain relief and improved function. Before any treatment begins, the subjects will be temporarily randomized into one of 4 MRI groups: 1) neutral positioning, followed by side-posture positioning (most painful side up); 2) neutral positioning, followed by side-posture adjusting (most painful side up), followed by neutral positioning; 3) neutral positioning, followed by side-posture adjusting (most painful side up) and remaining in side-posture; and 4) (pure control group) neutral positioning, followed by very brief side-posture positioning, followed by neutral positioning. MRI scans will be taken with the subjects in the original neutral position and in the final position. Both MRI scans will be conducted consecutively over approximately 30 minutes (12:19 minutes per scan). All spinal adjustments given during this appointment will be performed directly on the MRI gantry table after the first scan. A second MRI appointment will occur 2 weeks later, after 2 weeks of treatment. At the second MRI appointment, subjects will be assigned to the MRI group opposite to the one to which they were randomized during the first MRI appointment. Three observers, blinded to each other and to subject grouping, will make anterior-to-posterior measurements (A-P gap) of the Z joints directly from the MRI scans. The gapping difference between the second and first scans of each MRI appointment will be analyzed to determine if differences exist between the 4 groups. Results of the first and second MRI appointments will also be evaluated to determine if the amount of gapping is related to pain (at first MRI appointment), relief of pain (at the second MRI appointment - difference in Visual Analog Scale from initial exam to MRI appointment) and current (first MRI appointment) and change in disability (second MRI appointment - difference in Bournemouth Questionnaire scores). The results of this study will be used to increase understanding of the mechanism of action of lumbar side posture adjusting and side-posture positioning in acute LBP patients.

  Eligibility

Ages Eligible for Study:   21 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00284063

Locations
United States, Illinois
National University of Health Sciences
Lombard, Illinois, United States, 60148
Sponsors and Collaborators
National University of Health Sciences
Canadian Memorial Chiropractic College
Auburn University
Investigators
Principal Investigator: Gregory D. Cramer, DC, PhD National University of Health Sciences
  More Information

No publications provided

Responsible Party: Gregory D. Cramer, Dean of Research, National University of Health Sciences
ClinicalTrials.gov Identifier: NCT00284063     History of Changes
Other Study ID Numbers: 2 R01 AT000123-03
Study First Received: January 30, 2006
Last Updated: May 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by National University of Health Sciences:
spinal manipulation, zygapophysial joints

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014