Clinical trial NCT03008902: A Study of Effects of Age and Hyperkyphosis on Spine Motion and Loading
Official title: A Cross-sectional Study Using Motion Analysis to Determine Whether Age and Hyperkyphosis Are Associated With Thoracic Spine Motion and Loading
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kyphosis
Vertebral Fracture
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: University of Denver
First posted: 2017-01-04
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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).

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.

Eligibility criteria: No exclusion criteria shall be based on race, ethnicity, or sex.

Inclusion Criteria (Non-patient group):

* 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

Exclusion Criteria (Non-patient group):

• 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
* 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.

Inclusion Criteria (Patient group):

* 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.
* 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

Exclusion Criteria (Patient group):

• 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.

Primary outcomes:
measure: Thoracic spine range of motion, in degrees.
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Dennis Anderson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: