KyphosisNCT03008902
A Study of Effects of Age and Hyperkyphosis on Spine Motion and Loading
An observational study of Kyphosis and Vertebral Fracture, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
We are studying how spine movement changes with age, and when people have vertebral fractures (cracks in the bones of the spine) or hyperkyphosis (a forward stooped posture). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kyphosis, Vertebral Fracture
- What is being tested?
- Near-infrared passive motion capture recording
- Type of treatment
- Surgery or procedure
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2017to 31 Aug 2018
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Non-patients Non-patients, who have not have not been seen at BIDMC for vertebral fractures or hyperkyphosis, will be recruited from the local community. The non-patient group will consist of 16 healthy adults ages 18-40. Patients Patients, who have been seen at BIDMC for vertebral fractures or hyperkyphosis, will be identified by review of medical records. The patient group will consist of 32 adults ages 75 and older who have previously been diagnosed with a thoracic vertebral fracture at BIDMC.
Who may be able to join
- Males and females, ages 18 - 40 years
- Able to perform activities such as walking, standing, sitting, bending or lifting without assistance
- Willing to sign informed consent form
- Males and females, ages 75 years and older.
- Patients who received a lateral thoracic spine x-ray and had a diagnosis of a vertebral fracture (ICD9 - 805.2) in the year 2011 or later.
- At least 6 months since diagnosis of vertebral fracture.
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- Measurable T4-T12 Cobb angle in lateral thoracic spine x-ray.
- Currently living in the Boston area.
- Able to perform activities such as walking, standing, sitting, bending or lifting without assistance
- Willing to sign informed consent form
Who cannot join
- Conditions that might alter thoracic biomechanics: Examples of these include scoliosis, a history of traumatic thoracic injury or spinal surgery, neuromuscular conditions such as Parkinson's disease or muscular dystrophy.
- Body mass index > 30 kg/m2
- Pregnancy
- Latex allergies
- Currently taking muscle relaxers, steroids, or narcotics
- Participation in another research study with radiation exposure
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- Previous exposure to radiation as part of a medical procedure in the past six months
- Musculoskeletal injury or condition that is currently affecting normal activity or movement. Examples of this could include sprains, strains, dislocations or fractures that prevent one from walking, standing, sitting, bending or lifting in a normal manner.
- Conditions (unrelated to vertebral fracture and hyperkyphosis) that might alter thoracic biomechanics: Examples of these include scoliosis, a history of traumatic thoracic injury or spinal surgery, neuromuscular conditions such as Parkinson's disease or muscular dystrophy.
- Body mass index > 30 kg/m2
- Latex allergies
- Currently taking muscle relaxers, steroids, or narcotics
- Musculoskeletal injury or condition that is currently affecting normal activity or movement. Examples of this could include sprains, strains, dislocations or fractures that prevent one from walking, standing, sitting, bending or lifting in a normal manner.
- A score ≥10 on the Short Blessed Test, suggesting possible impaired cognitive function or dementia.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: A Cross-sectional Study Using Motion Analysis to Determine Whether Age and Hyperkyphosis Are Associated With Thoracic Spine Motion and Loading
We are studying how spine movement changes with age, and when people have vertebral fractures (cracks in the bones of the spine) or hyperkyphosis (a forward stooped posture).
Read the detailed description
The purpose of this study is to obtain unique measures of thoracic spinal motion in young, older, and hyperkyphotic older adults. We will then develop unique subject-specific musculoskeletal models of these individuals to estimate loads applied to the vertebrae in vivo, and examine how spinal motion and loading vary with age and increased kyphosis.
Vertebral fractures (VFs) are the most common type of fracture in older adults, occurring in 20-35% of women and 15-25% of men over the age of 50, and are associated with significant morbidity, increased mortality, and annual costs exceeding $1 billion in the United States. However, limited understanding of the mechanisms (beyond low vertebral bone mineral density and strength) that lead to VFs hinders our ability to predict and prevent these injuries.
Similarly, hyperkyphosis, defined as excess forward curvature of the thoracic spine, is suffered by 20-40% of older adults, but its causes are poorly understood and it has no standard clinical treatment. Hyperkyphosis and VFs are inter-related, as individuals with VFs often have worse kyphosis, while hyperkyphosis is an independent risk factor for future VFs. Hyperkyphosis may increase VF risk through increased vertebral loading, but better understanding is needed of the biomechanics of this common spine condition.
VFs occur more often at mid-thoracic (T7-T8) and thoraco-lumbar (T12-L1) vertebrae than elsewhere in the spine, and it has been suggested that biomechanical factors predispose these areas to fracture by increasing vertebral loading. In the first phase of this project, a novel musculoskeletal model was developed that uniquely predicts peaks in vertebral loading around the T12-L1 region of the spine, but this was not observed in the mid-thoracic region. Our preliminary data suggested that increased thoracic stiffness causes greater vertebral loading at mid-thoracic levels (T7-T9), while increased thoracic kyphosis increases vertebral loading, particularly in the thoraco-lumbar (T12-L1) region.
Further advances in musculoskeletal modeling will are needed to fully evaluate these possibilities, but a particular knowledge gap remains regarding the in vivo kinematics of the thoracic spine and ribcage in both healthy and hyperkyphotic individuals. This project aims to fill that gap by producing novel in vivo measurements of thoracic spine motion in young, older, and hyperkyphotic older adults.
- Conditions
- Kyphosis, Vertebral Fracture
- Being tested
- Near-infrared passive motion capture recording
- Medical subject headings
- Kyphosis, Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near-infrared passive motion capture recordingProcedure or surgery
Full body movement will be recorded during movements using near infrared passive motion capture. This procedure is non-invasive and standard practice in biomechanics labs. Movement will be recorded using an eight-camera system. Retroreflective markers are placed at strategic joint locations to characterize limb movement. Accuracies of the marker positions are sub-millimeter, and allow accurate characterization of limb rotation and translation during movements. Passive reflective marker clusters (3 markers each) will be attached to subjects at 8 locations along the spine. Additional markers will be applied to the manubrium of the sternum, head, pelvis, and extremities. Eight EMG surface electrode pairs will be used to record activation from the left and right erector spinae, latissimus dorsi, trapezius and rectus abdominis muscles during all motions.
| Study group | Role | What they receive |
|---|---|---|
| Non-patients | Non-patients, who have not had vertebral fractures or hyperkyphosis, and have not been seen at BIDMC, will be recruited from the community as described in section B3C and B6 below. The non-patient group will consist of 16 healthy adults ages 18-40. Receives: Procedure: Near-infrared passive motion capture recording | |
| Patients | Patients, who have been seen at BIDMC for vertebral fractures or hyperkyphosis, will be identified by review of medical records as described in B3C and B6 below. The patient group will consist of 32 adults ages 75 and older who have previously been diagnosed with a thoracic vertebral fracture at BIDMC. Receives: Procedure: Near-infrared passive motion capture recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thoracic spine range of motion, in degrees.
Full body movement will be recorded during subject movements using near infrared passive motion capture. This procedure is non-invasive and standard practice in biomechanics labs. Passive reflective marker clusters will be attached to subjects along the spine at T1, T4, T5, T8, T9, T12, L1, and additional markers will be applied to the manubrium of the sternum, head, pelvis, and extremities. Marker positions during subject movements will be recorded with sub-millimeter accuracy using an eight-camera system from Vicon Motion Systems (Centennial, CO). Recorded marker positions will be applied to a musculoskeletal model of the subject through an inverse kinematics algorithm in order to provide estimates of thoracic spine angular range of motion in flexion-extension, lateral bending, and axial rotation during each subject movement.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study start18 Apr 2017
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KyphosisStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Denver
- Responsible party
- Principal investigator, Dennis Anderson, Beth Israel Deaconess Medical Center
- Investigators
- Dennis Anderson, Ph.D., Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03008902
- Sponsor's protocol ID
- 2015P000394
- Status last verified
- Oct 2018
- First submitted
- 16 Dec 2016
- Last updated
- 4 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Study Using Motion Analysis to Determine Whether Age and Hyperkyphosis Are Associated With Thoracic Spine Motion and Loading
- ClinicalTrials.gov ID
- NCT03008902
- Acronym / sponsor ID
- 2015P000394
- Conditions
- Kyphosis, Vertebral Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- University of Denver
- Study start
- 18 Apr 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 4 Jan 2017 (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.
We are studying how spine movement changes with age, and when people have vertebral fractures (cracks in the bones of the spine) or hyperkyphosis (a forward stooped posture).
Detailed description
The purpose of this study is to obtain unique measures of thoracic spinal motion in young, older, and hyperkyphotic older adults. We will then develop unique subject-specific musculoskeletal models of these individuals to estimate loads applied to the vertebrae in vivo, and examine how spinal motion and loading vary with age and increased kyphosis.
Vertebral fractures (VFs) are the most common type of fracture in older adults, occurring in 20-35% of women and 15-25% of men over the age of 50, and are associated with significant morbidity, increased mortality, and annual costs exceeding $1 billion in the United States. However, limited understanding of the mechanisms (beyond low vertebral bone mineral density and strength) that lead to VFs hinders our ability to predict and prevent these injuries.
Similarly, hyperkyphosis, defined as excess forward curvature of the thoracic spine, is suffered by 20-40% of older adults, but its causes are poorly understood and it has no standard clinical treatment. Hyperkyphosis and VFs are inter-related, as individuals with VFs often have worse kyphosis, while hyperkyphosis is an independent risk factor for future VFs. Hyperkyphosis may increase VF risk through increased vertebral loading, but better understanding is needed of the biomechanics of this common spine condition.
VFs occur more often at mid-thoracic (T7-T8) and thoraco-lumbar (T12-L1) vertebrae than elsewhere in the spine, and it has been suggested that biomechanical factors predispose these areas to fracture by increasing vertebral loading. In the first phase of this project, a novel musculoskeletal model was developed that uniquely predicts peaks in vertebral loading around the T12-L1 region of the spine, but this was not observed in the mid-thoracic region. Our preliminary data suggested that increased thoracic stiffness causes greater vertebral loading at mid-thoracic levels (T7-T9), while increased thoracic kyphosis increases vertebral loading, particularly in the thoraco-lumbar (T12-L1) region.
Further advances in musculoskeletal modeling will are needed to fully evaluate these possibilities, but a particular knowledge gap remains regarding the in vivo kinematics of the thoracic spine and ribcage in both healthy and hyperkyphotic individuals. This project aims to fill that gap by producing novel in vivo measurements of thoracic spine motion in young, older, and hyperkyphotic older adults.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-patients | – | Procedure: Near-infrared passive motion capture recordingNon-patients, who have not had vertebral fractures or hyperkyphosis, and have not been seen at BIDMC, will be recruited from the community as described in section B3C and B6 below. The non-patient group will consist of 16 healthy adults ages 18-40. |
| Patients | – | Procedure: Near-infrared passive motion capture recordingPatients, who have been seen at BIDMC for vertebral fractures or hyperkyphosis, will be identified by review of medical records as described in B3C and B6 below. The patient group will consist of 32 adults ages 75 and older who have previously been diagnosed with a thoracic vertebral fracture at BIDMC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Non-patients Non-patients, who have not have not been seen at BIDMC for vertebral fractures or hyperkyphosis, will be recruited from the local community. The non-patient group will consist of 16 healthy adults ages 18-40. Patients Patients, who have been seen at BIDMC for vertebral fractures or hyperkyphosis, will be identified by review of medical records. The patient group will consist of 32 adults ages 75 and older who have previously been diagnosed with a thoracic vertebral fracture at BIDMC.
Key inclusion criteria (10 listed)
- Males and females, ages 18 - 40 years
- Able to perform activities such as walking, standing, sitting, bending or lifting without assistance
- Willing to sign informed consent form
- Males and females, ages 75 years and older.
- Patients who received a lateral thoracic spine x-ray and had a diagnosis of a vertebral fracture (ICD9 - 805.2) in the year 2011 or later.
Key exclusion criteria (14 listed)
- Conditions that might alter thoracic biomechanics: Examples of these include scoliosis, a history of traumatic thoracic injury or spinal surgery, neuromuscular conditions such as Parkinson's disease or muscular dystrophy.
- Body mass index > 30 kg/m2
- Pregnancy
- Latex allergies
- Currently taking muscle relaxers, steroids, or narcotics
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 |
|---|---|---|
| Near-infrared passive motion capture recordingFull body movement will be recorded during movements using near infrared passive motion capture. This procedure is non-invasive and standard practice in biomechanics labs. Movement will be recorded using an eight-camera system. Retroreflective markers are placed at strategic joint locations to characterize limb movement. Accuracies of the marker positions are sub-millimeter, and allow accurate characterization of limb rotation and translation during movements. Passive reflective marker clusters (3 markers each) will be attached to subjects at 8 locations along the spine. Additional markers will be applied to the manubrium of the sternum, head, pelvis, and extremities. Eight EMG surface electrode pairs will be used to record activation from the left and right erector spinae, latissimus dorsi, trapezius and rectus abdominis muscles during all motions. | Procedure or surgery | Non-patients, Patients |
Primary outcome
Thoracic spine range of motion, in degrees.
Time frame: Day 1
Full body movement will be recorded during subject movements using near infrared passive motion capture. This procedure is non-invasive and standard practice in biomechanics labs. Passive reflective marker clusters will be attached to subjects along the spine at T1, T4, T5, T8, T9, T12, L1, and additional markers will be applied to the manubrium of the sternum, head, pelvis, and extremities. Marker positions during subject movements will be recorded with sub-millimeter accuracy using an eight-camera system from Vicon Motion Systems (Centennial, CO). Recorded marker positions will be applied to a musculoskeletal model of the subject through an inverse kinematics algorithm in order to provide estimates of thoracic spine angular range of motion in flexion-extension, lateral bending, and axial rotation during each subject movement.
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 4 Oct 2018.
- Individual participant dataSharing planned: No
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Basic Body Awareness Therapy (BBAT) and Corrective Exercise for Adolescent Hyperkyphosis
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Surface Electromyographic Analysis of Scapular Stabilizer Muscle in Postural Hyperkyphosis
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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.
Dennis Anderson, Ph.D. principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kyphosis and Vertebral Fracture, run by Beth Israel Deaconess Medical Center 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 10 inclusion and 14 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 4 Oct 2018. 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?
Thoracic spine range of motion, in degrees. (time frame: Day 1). 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 4 Oct 2018.