Sacroiliac Joint PainNCT00620906
Motion Capture Analysis of Sacroiliac Joint Motion After Manipulation
A study testing Manipulation in people with Sacroiliac Joint Pain, run by Logan College of Chiropractic at 1 site in United States.
Trial summary
The purpose of this study is to examine the effects of manipulation on sacroiliac joint motion using a Polhemus motion capture system. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Sacroiliac Joint Pain
- What is being tested?
- Manipulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Mar 2008
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages between 20 and 40
- Ability to maintain normal balance
- Willingness to undergo HVLA manipulation to the SI Joints
- Normal blood pressure
Who cannot join
- Any visual or vestibular condition or systemic illness that would affect balance
- Any recent surgery, unstable joints of the lower extremity, recent hip and knee joint replacements or fitted hip or knee pins, bolts and/or plates
- Currently have any infection, acute inflammation, recent wounds, injury, tumors or other malignancy
- Currently taking any medications; prescription or herbal muscle stimulants, relaxants, etc.
- A history of acute disc herniation, discopathy or spondylolysis
- A history of acute thrombosis, serious cardiovascular disease, diabetes, have irregular heartbeats(arrhythmia) or wear a pacemaker
Show all 10Show fewer
- Any implanted device or prosthesis type of device
- Any Spinal manipulation within 48 hours
- Ages under 20 and over 40
- Estimated BMI greater than 30
Trial locations and contacts
1 site in 1 country.
United States1 site
Logan College of Chiropractic
Chesterfield, Missouri, 63006
About this study
The purpose of this study is to examine the effects of manipulation on sacroiliac joint motion using a Polhemus motion capture system.
Read the detailed description
The Sacroiliac (SI) joint is a diarthrodial joint with the contradictory biomechanical function of transmitting compressive loads from the lumbar spine to the lower extremity while maintaining a nutating motion in the pelvis.
Recent studies identify the Sacroiliac (SI) joints as a significant source of pain in patients with chronic low back pain, contributing up to 27%. Recent studies have demonstrated that historical and physical examination findings and radiological imaging alone are insufficient to diagnose SI joint pain.
The purpose of this study is to examine the effects of manipulation on sacroiliac joint motion using a Polhemus motion capture system. The Absolute angular deviation of sacroiliac joint motion will be assessed during the normal gait cycle with the Polhemus Liberty motion capture system. Six sensors will be attached to specific anatomical landmarks of the pelvis which recorded motion characteristics while walking on a treadmill at 5 mph. The subjects then receive a HVLA manipulation to the SI joint and were retested at the same treadmill speed.
The Motion capture system tracks objects at a speed of 240 updates per second on all sensors simultaneously. The latency of data sampling is less than 4ms; 240 x 60 sec x 8 Sensors totaling 115,200 data points per minute. The system generates and tracks electromagnetic fields (EMF), computes position and orientation of sensors in an X, Y, and Z coordinate system while interfacing with a computer. The EMF source contains electromagnetic coils that emit a magnetic field. The source is the system's reference frame for sensor measurements. The sensor contains electromagnetic coils (accelerometers) that detect the position and orientation of the magnetic fields emitted by the EMF source.
- Conditions
- Sacroiliac Joint Pain
- Being tested
- Manipulation
- Keywords
- manipulation, manual therapy, Sacroiliac joint, effects on manipulation on sacroiliac joint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ManipulationProcedure or surgery
HVLA manipulation to Sacroiliac Joint
| Study group | Role | What they receive |
|---|---|---|
| A | Other | Manipulation Receives: Procedure: Manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sacroiliac joint motion was assessed with the Polhemus Liberty motion capture system.
Measured: Pre and Post therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startJan 2007
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacroiliac Joint 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Logan College of Chiropractic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dennis Enix, DC, MBA, Logan College of Chiropractic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00620906
- Sponsor's protocol ID
- RD0524070094
- Status last verified
- May 2013
- First submitted
- 12 Feb 2008
- Last updated
- 3 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motion Capture Analysis of Sacroiliac Joint Motion After Manipulation
- ClinicalTrials.gov ID
- NCT00620906
- Acronym / sponsor ID
- RD0524070094
- Conditions
- Sacroiliac Joint Pain
- Keywords
- manipulation, manual therapy, Sacroiliac joint, effects on manipulation on sacroiliac joint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Logan College of ChiropracticUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 22 Feb 2008 (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 study is to examine the effects of manipulation on sacroiliac joint motion using a Polhemus motion capture system.
Detailed description
The Sacroiliac (SI) joint is a diarthrodial joint with the contradictory biomechanical function of transmitting compressive loads from the lumbar spine to the lower extremity while maintaining a nutating motion in the pelvis.
Recent studies identify the Sacroiliac (SI) joints as a significant source of pain in patients with chronic low back pain, contributing up to 27%. Recent studies have demonstrated that historical and physical examination findings and radiological imaging alone are insufficient to diagnose SI joint pain.
The purpose of this study is to examine the effects of manipulation on sacroiliac joint motion using a Polhemus motion capture system. The Absolute angular deviation of sacroiliac joint motion will be assessed during the normal gait cycle with the Polhemus Liberty motion capture system. Six sensors will be attached to specific anatomical landmarks of the pelvis which recorded motion characteristics while walking on a treadmill at 5 mph. The subjects then receive a HVLA manipulation to the SI joint and were retested at the same treadmill speed.
The Motion capture system tracks objects at a speed of 240 updates per second on all sensors simultaneously. The latency of data sampling is less than 4ms; 240 x 60 sec x 8 Sensors totaling 115,200 data points per minute. The system generates and tracks electromagnetic fields (EMF), computes position and orientation of sensors in an X, Y, and Z coordinate system while interfacing with a computer. The EMF source contains electromagnetic coils that emit a magnetic field. The source is the system's reference frame for sensor measurements. The sensor contains electromagnetic coils (accelerometers) that detect the position and orientation of the magnetic fields emitted by the EMF source.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Other | Procedure: ManipulationManipulation |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Ages between 20 and 40
- Ability to maintain normal balance
- Willingness to undergo HVLA manipulation to the SI Joints
- Normal blood pressure
Key exclusion criteria (10 listed)
- Any visual or vestibular condition or systemic illness that would affect balance
- Any recent surgery, unstable joints of the lower extremity, recent hip and knee joint replacements or fitted hip or knee pins, bolts and/or plates
- Currently have any infection, acute inflammation, recent wounds, injury, tumors or other malignancy
- Currently taking any medications; prescription or herbal muscle stimulants, relaxants, etc.
- A history of acute disc herniation, discopathy or spondylolysis
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 |
|---|---|---|
| ManipulationHVLA manipulation to Sacroiliac Joint | Procedure or surgery | A |
Primary outcome
Sacroiliac joint motion was assessed with the Polhemus Liberty motion capture system.
Time frame: Pre and Post therapy
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 3 May 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manipulation in people with Sacroiliac Joint Pain, run by Logan College of Chiropractic 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 10 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 3 May 2013. 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?
Sacroiliac joint motion was assessed with the Polhemus Liberty motion capture system. (time frame: Pre and Post therapy). 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 3 May 2013.