Lower Back PainPhase 1NCT00070902
Using MRI Scans to Evaluate Spinal Manipulation
A Phase 1 study testing Lumbar side-posture spinal adjusting in people with Lower Back Pain, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower Back Pain
- What is being tested?
- Lumbar side-posture spinal adjusting
- Type of treatment
- Surgery or procedure
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2000to Oct 2002
- Phase
- Phase 1
- 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 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National University of Health Sciences
Lombard, Illinois, 60148
About this study
Official title: The Effects of Positioning and Adjusting on the Z Joint
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.
Read the 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).
- Conditions
- Lower Back Pain
- Being tested
- Lumbar side-posture spinal adjusting
- Keywords
- Spinal Manipulation, Chiropractic, 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.
Lumbar side-posture spinal adjustingProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2003 (estimated)
- Study startJun 2000
- Study completionOct 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lower 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 64 participants
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Gregory D. Cramer, DC, PhD, Principal investigator, National University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00070902
- Sponsor's protocol ID
- R01AT000123-01
- Status last verified
- Aug 2006
- First submitted
- 9 Oct 2003
- Last updated
- 18 Aug 2006
- Results posted
- No
Publications
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.
PubMed 12435975Cramer 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.
PubMed 10951308
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Positioning and Adjusting on the Z Joint
- ClinicalTrials.gov ID
- NCT00070902
- Acronym / sponsor ID
- R01AT000123-01
- Conditions
- Lower Back Pain
- Keywords
- Spinal Manipulation, Chiropractic, Zygapophysial Joints
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Jun 2000
- Study completion
- Oct 2002
- First posted
- 13 Oct 2003 (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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 21 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Lumbar side-posture spinal adjusting | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 18 Aug 2006.
- Background: PubMed 12435975Cramer 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.
- Background: PubMed 10951308Cramer 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.
- National University of Health SciencesLink provided by the sponsor.
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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 Phase 1 study testing Lumbar side-posture spinal adjusting in people with Lower Back Pain, run by National Center for Complementary and Integrative Health (NCCIH) 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 3 inclusion and 5 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 18 Aug 2006. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00070902, which also lists 2 linked publications.
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 18 Aug 2006.