Mechanical Low Back PainNCT00284063
Z-Joint Changes in Low Back Pain Following Adjusting
A study testing Low back adjustment and MRI and MRI in people with Mechanical Low Back Pain, run by National University of Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 69 years
- Conditions the study is for
- Mechanical Low Back Pain
- What is being tested?
- Low back adjustment and MRI and MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2006to 30 Sep 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National University of Health Sciences
Lombard, Illinois, 60148
About this study
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.
Read the 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.
- Conditions
- Mechanical Low Back Pain
- Being tested
- Low back adjustment and MRI, MRI
- Keywords
- spinal manipulation, zygapophysial joints
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low back adjustment and MRIProcedure or surgery
Also called spinal manipulation = spinal adjustment
Subjects received a 15 minutes MRI in neutral position, a chiropractic low back spinal manipulation, and a second 15 minute MRI in neutral position.
Low back adjustment and MRIProcedure or surgery
Also called spinal manipulation = spinal adjustment
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.
MRIProcedure or surgery
Also called spinal manipulation = spinal adjustment
Subjects received a 15 minute MRI in neutral position and a second 15 minute MRI in neutral position.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: N; SPP; N | Active comparator | N = neutral MRI; SP = side posture MRI; SPP = side posture position; SMT = side posture manipulation Receives: Procedure: MRI |
| Group 2: N; SMT; N | Active comparator | N = neutral MRI; SP = side posture MRI; SPP = side posture position; SMT = side posture manipulation Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior to posterior measurements (A-P gap) of the Z joints.
Measured: February 2006-December 2011
Secondary outcomes (2)
Amount of gapping will be compared to relief of pain (Visual Analog Scale).
Measured: February 2006-January 2010
Amount of gapping compared to disability (Bournemouth Questionnaire)
Measured: February 2006-January 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2006 (estimated)
- Study start31 Jan 2006
- Primary completion1 Dec 2009
- Study completion30 Sep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Memorial Chiropractic College, Auburn University
- Responsible party
- Principal investigator, Gregory D. Cramer, National University of Health Sciences
- Investigators
- Gregory D. Cramer, DC, PhD, Principal investigator, National University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00284063
- Sponsor's protocol ID
- 2R01AT000123-03
- Status last verified
- Apr 2015
- First submitted
- 30 Jan 2006
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Z-Joint Changes in Low Back Pain Following Adjusting
- ClinicalTrials.gov ID
- NCT00284063
- Acronym / sponsor ID
- 2R01AT000123-03
- Conditions
- Mechanical Low Back Pain
- Keywords
- spinal manipulation, zygapophysial joints
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- National University of Health SciencesUniversity, hospital or other
- Collaborators
- Canadian Memorial Chiropractic College, Auburn University
- Study start
- 31 Jan 2006 (actual)
- Primary completion
- 1 Dec 2009 (actual)
- Study completion
- 30 Sep 2010 (actual)
- First posted
- 31 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: N; SPP; N | Active comparator | Procedure: MRIN = neutral MRI; SP = side posture MRI; SPP = side posture position; SMT = side posture manipulation |
| Group 2: N; SMT; N | Active comparator | Procedure: Low back adjustment and MRIN = neutral MRI; SP = side posture MRI; SPP = side posture position; SMT = side posture manipulation |
| Group 3: N; SMT; SP | Active comparator | Procedure: Low back adjustment and MRIN = neutral MRI; SP = side posture MRI; SPP = side posture position; SMT = side posture manipulation |
| Group 4: N and SP | No intervention | –N = neutral MRI SP = side posture MRI SPP = side posture position SMT = side posture manipulation |
Who may qualify
- Ages
- 21 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low back adjustment and MRIAlso: spinal manipulation = spinal adjustmentSubjects received a 15 minutes MRI in neutral position, a chiropractic low back spinal manipulation, and a second 15 minute MRI in neutral position. | Procedure or surgery | Group 2: N; SMT; N |
| Low back adjustment and MRIAlso: spinal manipulation = spinal adjustmentSubjects 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. | Procedure or surgery | Group 3: N; SMT; SP |
| MRIAlso: spinal manipulation = spinal adjustmentSubjects received a 15 minute MRI in neutral position and a second 15 minute MRI in neutral position. | Procedure or surgery | Group 1: N; SPP; N |
Primary outcome
Anterior to posterior measurements (A-P gap) of the Z joints.
Time frame: February 2006-December 2011
2 secondary outcomes
Amount of gapping will be compared to relief of pain (Visual Analog Scale).
Time frame: February 2006-January 2010
Amount of gapping compared to disability (Bournemouth Questionnaire)
Time frame: February 2006-January 2009
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory D. Cramer, DC, PhD principal investigator
National University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low back adjustment and MRI and MRI in people with Mechanical Low Back Pain, run by National University of Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anterior to posterior measurements (A-P gap) of the Z joints. (time frame: February 2006-December 2011). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2022.