Aging, Mobility and Chronic Low Back Pain

March 11, 2024 updated by: McMaster University

Studying Aging, Mobility and Chronic Low Back Pain in Older Adults Using Remote Monitoring

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Harsha Shanthanna, MD, PhD
  • Phone Number: 33853 (+1) 905-522-1155
  • Email: shanthh@mcmaster.ca

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph's Healthcare Hamilton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 80 years (Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control group
Participants without CLBP. Measurements include: bio-physiological, neurophysiological measurements at baseline. Remote monitoring of gait, physical activity for 7 days using inertial measurement unit (IMU) with wearable devices.
Other: No intervention will be given to the participants
This is an observational feasibility study with no intervention.
Active group
Participants with CLBP. Measurements include: bio-physiological, neurophysiological measurements at baseline. Remote monitoring of gait, physical activity for 7 days using inertial measurement unit (IMU) with wearable devices. Self-reported measures of pain and type of activity for 7 days using electronic dairy.
Other: No intervention will be given to the participants
This is an observational feasibility study with no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total time and patterns of wearing the study devices
Time Frame: 7 days
To assess the compliance of the wearable devices (MetaMotionS IMU to be worn on both of a participant's ankles), time and patterns (all the time, part of the time and when) of wearing them during the study period will be measured with consistent data capture by the devices.
7 days
System Usability Scale (SUS) (ranges from 0 to 100; a higher score indicates better acceptability)
Time Frame: On Day 7
At the end of study, the SUS questionnaire will used to assess participants' acceptability of wearing of the study devices.
On Day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Back Performance Scale (BPS) (range from 0 to 15; a higher score indicates worse performance)
Time Frame: At baseline
The association between BPS measured at baseline and chronic low back pain will be assessed.
At baseline
Self-paced walking test
Time Frame: At baseline
Distance (unit: metres) completed in the self-paced two-minute walk test will be measured at baseline. The association between this value and chronic low back pain will be assessed.
At baseline
Neurophysiological markers
Time Frame: At baseline
The association between the neurophysiological markers measured from transcranial magnetic stimulation at baseline and chronic low back pain will be assessed.
At baseline
Gait and physical activity
Time Frame: 7 days
The association between the physical activity measured using remote monitoring during the study period and chronic low back pain will be assessed.
7 days
Subgroups of chronic low back pain (CLBP)
Time Frame: 7 days
All the collected data including the baseline variables and parameters measured with activity monitoring will be used to explore subgroups of CLBP using effective machine learning methods.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

St. Joseph's Healthcare Hamilton

Investigators

  • Principal Investigator: Harsha Shanthanna, MD, PhD, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2023

Primary Completion (Actual)

February 14, 2024

Study Completion (Estimated)

December 15, 2024

Study Registration Dates

First Submitted

November 15, 2021

First Submitted That Met QC Criteria

December 16, 2021

First Posted (Actual)

December 22, 2021

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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