Clinical trial NCT05167877: Aging, Mobility and Chronic Low Back Pain
Official title: Studying Aging, Mobility and Chronic Low Back Pain in Older Adults Using Remote Monitoring
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Low Back Pain
Chronic Pain
Keywords: Low Back Pain
Chronic
Older Adults
Mobility
Remote Monitoring
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: St. Joseph's Healthcare Hamilton
First posted: 2021-12-22
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly patients without chronic low back pain (CLBP) for control group, and elderly patients with CLBP for active group.

Brief summary: Chronic low back pain (CLBP) is very common in older adults and is one of the most common reasons for disability and poor quality of life. Lack of physical activity is considered to negatively impact CLBP and show an inverse association with pain symptoms and limitations.

Remote and real-time monitoring can allow ecological momentary assessment which involves repeated sampling of participants' current behaviors and experiences in their natural environments. Recent advances allow monitoring of activity using inertial measurement units (consisting of accelerometers, gyroscopes and magnetometers) that can be worn by an individual at home or during work.

In our study, we plan to test the feasibility and acceptability of the wearable devices in elderly patients with CLBP and to explore the use of data analytics and machine learning on the recorded data, in order to demonstrate the feasibility of a larger cohort study.

Detailed description: Chronic low back pain (CLBP) is a common condition in elderly population. CLBP is associated with disability and poor quality of life worldwide. Studies have found that the lack of physical activity may negatively impact CLBP and show an inverse association with pain symptoms and limitations. For example, a study demonstrates that physically active patients with CLBP experience less pain \[- 0.6, 95% confidence interval (CI): - 1.0 to - 0.1; 0-10 numerical pain scale\] and disability (- 8.7, 95% CI: - 14.2 to - 3.1; 0-100 disability scale) compared to patients not adequately active. However, most reports are based on younger adults or using cross-sectional studies with no continuous or real-life monitoring.

Functionally, pain with movement is more important than resting pain. This is especially true of CLBP, which increases in severity with movement. Physical activity has health benefits, including for chronic pain conditions. However, many pain patients suffer from kinesiophobia and consider exercise to be unhelpful. There is uncertainty around exercise induced analgesia, as well as the type of activity in musculoskeletal pain. The present approach to pain recording, suffers from limitations including recall, and does not relate to associated physical activity. With this, the primary drivers of pain-sensory, psychological, and motor factors are studied in isolation. Additionally, objective markers of analgesia and neuroplasticity related to physical activity have not been well studied. There is a paradoxical relationship between physical activity to treat pain and participation in physical activity evoking pain. Most studies on movement evoked pain have been using paradigms of experimental movements which are not natural to patients, and do not consider the influence of contextual factors. Remote and real-time monitoring provides us possibility of measuring the subjects' real-time behaviors and experience. The wearable remote devices are developed to monitor activity and provide large data for various analyses.

The investigators will use an inertial measurement unit (IMU)-based device containing accelerometer, gyroscope and magnetometer worn on each ankle (like a watch) in the current study. The device is capable of measuring spatiotemporal gait parameters (such as asymmetry, variability, speed, stride time, stance to swing ratio, minimum foot clearance) along with type and amount of physical activity. The investigators will capture real-time pain intensity, type, and context of activity using an electronic diary in the form of a wristwatch. Data from both devices will be integrated for processing and analysis, including the use of machine learning and data analytics to develop predictive models. In the present proposal (the first phase), the investigators will use these devices on older adults with mobility (\>65 years and \<80 years) with (active group) or without CLBP (control group). In this phase, the investigators plan to complete the feasibility and acceptability of these devices and obtain pilot data to support the applications for the larger study funding. After the first phase, the investigators plan to conduct a larger cohort study in older adult CLBP patients using the study devices and applications at the participants' home/living settings.

Eligibility criteria: Inclusion Criteria:

* Age \>65 and \<80 years
* patients with present and known history of non-specific chronic low back pain (CLBP) will be included in the active group
* participants without CLBP will be included in the control group
* ability to comprehend or understand commands in English language

Exclusion Criteria:

* Presence of any unstable cardio-respiratory comorbidity such as congestive heart failure, severe coronary disease, severe chronic obstructive pulmonary disease, or asthma needing daily treatment with puffers
* known history of neurocognitive impairment
* known history of untreated or uncontrolled psychological disorders
* history of previous back surgery
* presence of moderate to severe knee, ankle, or foot pain, and other physical impairments needing walking assistance
* participants expected to receive a new medication treatment or injection for their CLBP during the study week

Primary outcomes:
measure: Total time and patterns of wearing the study devices
timeFrame: 7 days
measure: System Usability Scale (SUS) (ranges from 0 to 100; a higher score indicates better acceptability)
timeFrame: On Day 7
Secondary outcomes:
measure: Back Performance Scale (BPS) (range from 0 to 15; a higher score indicates worse performance)
timeFrame: At baseline
measure: Self-paced walking test
timeFrame: At baseline
measure: Neurophysiological markers
timeFrame: At baseline
measure: Gait and physical activity
timeFrame: 7 days
measure: Subgroups of chronic low back pain (CLBP)
timeFrame: 7 days
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: McMaster University
name: Harsha Shanthanna, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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