Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT04498806 |
| Other study ID # |
113995 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 13, 2018 |
| Est. completion date |
August 2025 |
Study information
| Verified date |
April 2024 |
| Source |
University of Utah |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The investigators objective of this research is to compare activity monitor results with
standard of care (SOC) question-based outcome measures for degenerative cervical myelopathy
patients before and after treatment with decompression.
Understanding of the relationship between activity monitor data and question-based outcome
measures in the context of degenerative cervical myelopathy will improve our understanding of
the disease and limit the effort to diagnose and monitor it.
Description:
Degenerative cervical myelopathy (DCM) is the most common cause of spinal dysfunction across
the world and a major cause of disability. DCM describes a group of conditions that
progressively impinge on the spinal cord resulting in functional impairment and a reduced
quality of life. Degenerative diseases of the spine increase in prevalence with increases in
age. A cadaver study of 469 adults found cervical stenosis of at least one level in 19.2% of
adults, 24.5% in those older than 50 and 27% of those older than 70 years. By 2050 the global
population over 60 years of age is expected to approach 2 billion. DCM is certainly a
prevalent disease in the elderly and will only become more common. For these reasons DCM must
be addressed thoroughly in research to improve outcomes.
Symptoms of afflicted patients often include neck pain, numbness/clumsiness in the hands,
weakness, upper and lower extremity motor deficits, balance and gait impairment, among
others. Non-surgical treatment has limited efficacy, while early surgical treatment is
recommended to halt progression, initiate recovery and improve symptoms. Surgical treatment
is widely agreed upon, yet measurement of surgical outcomes can be challenging.
Traditionally, assessment of outcomes has been performed subjectively using
questionnaires/functional assessments. These question-based outcome measures are popular due
to practicality and ease of administration. Examples that have been used in Degenerative
Cervical Myelopathy (DCM) include Neck Disability Index (NDI), Myelopathy Disability Index
(MDI), Japanese Orthopedic Association (JOA), European Myelopathy Score (EMS), Nurick Score,
Ranawat Score, Odom's criteria and Short Form-36 survey (SF-36). This introduces
incompatibility when comparing studies using different questionnaires. In addition to the
lack of consensus in a standard questionnaire, there are inherent biases in the use of
self-reported measures. Self-reported questionnaires and objective disability measures do not
always agree, particularly when recent setbacks distort a patients' perception of total
improvement. Personal evaluation is subject to inherent bias with a disconnect between
perception of disability and actual objective performance.
Gait disturbance may be the most be the most prominent physical finding in DCM, and walking
tests have been established as effective, objective measures in DCM pre and post-operatively.
A patient's activity level at home provides valuable data on recovery and surgical efficacy,
yet prior to wearable technology required self-reported data. Accelerometers have been used
to remedy this problem by measuring activity trends in a quantifiable manner, without relying
on the subjective response of the patient. They have recently been implemented in orthopedic
research. Investigators have compared self-rated disability with objective accelerometer data
in patients suffering from lumbar spinal stenosis (LSS) and found self-rated disability did
not always reflect objective data. Some investigators used these methods to objectively
measure function after surgical intervention, lumbar spinal stenosis decompression. Results
are promising and require further investigation into the application of this new tool.
In summary accelerometers offer longitudinal objective measurement of walking and the ability
to look at trends in activity levels. Eventually walking measures could be used to monitor
patients with mild myelopathy for progression and possibly even be part of a remote screening
tool (i.e. a phone tracks walking distance, speed, number of falls per month and prompts for
monthly or quarterly handwriting samples). We aim to apply similar concepts of prior
investigations to compare accelerometer and question-based outcome data on DCM patients
before and after undergoing surgical intervention, to determine the most practical and
accurate method for outcome measurement. By incorporating activity monitor data and looking
at relationships between the different measures, we will be able to better understand the
disease and limit the effort required to diagnose and monitor it.
