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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00070902
Other study ID # R01AT000123-01
Secondary ID
Status Completed
Phase Phase 1
First received October 9, 2003
Last updated August 16, 2006
Start date June 2000
Est. completion date October 2002

Study information

Verified date August 2006
Source National Center for Complementary and Integrative Health (NCCIH)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date October 2002
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years to 29 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Lumbar side-posture spinal adjusting


Locations

Country Name City State
United States National University of Health Sciences Lombard Illinois

Sponsors (1)

Lead Sponsor Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

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