Aging, Mobility and Chronic Low Back Pain

NCT05167877 | Completed

• 1 other identifier: 21-011
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain; Chronic Pain

Keywords

Low Back Pain; Chronic; Older Adults; Mobility; Remote Monitoring

Outcome Measures

Primary Outcomes (2)

• Total time and patterns of wearing the study devices

  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)

  At the end of study, the SUS questionnaire will used to assess participants' acceptability of wearing of the study devices.

  On Day 7

Secondary Outcomes (5)

• Back Performance Scale (BPS) (range from 0 to 15; a higher score indicates worse performance)

  At baseline

• Self-paced walking test

  At baseline

• Neurophysiological markers

  At baseline

• Gait and physical activity

  7 days

• Subgroups of chronic low back pain (CLBP)

  7 days

Study Arms (2)

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

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

Interventions

No intervention will be given to the participants OTHER

This is an observational feasibility study with no intervention.

Active group; Control group

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead
• St. Joseph's Healthcare Hamilton: collaborator

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Related Publications (31)

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  PMID: 23478452 RESULT

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  PMID: 22511582 RESULT

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• Butera KA, Fox EJ, George SZ. Toward a Transformed Understanding: From Pain and Movement to Pain With Movement. Phys Ther. 2016 Oct;96(10):1503-1507. doi: 10.2522/ptj.20160211. No abstract available.

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  RESULT

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• Keogh A, Dorn JF, Walsh L, Calvo F, Caulfield B. Comparing the Usability and Acceptability of Wearable Sensors Among Older Irish Adults in a Real-World Context: Observational Study. JMIR Mhealth Uhealth. 2020 Apr 20;8(4):e15704. doi: 10.2196/15704.

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MeSH Terms

Conditions

Low Back Pain; Chronic Pain; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Harsha Shanthanna, MD, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: December 22, 2021
• Study Start: January 15, 2023
• Primary Completion: February 14, 2024
• Study Completion: December 15, 2024
• Last Updated: June 4, 2026

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)