Aging, Mobility and Chronic Low Back Pain (NCT05167877) | Clinical Trial Compass
CompletedNot Applicable
Aging, Mobility and Chronic Low Back Pain
Canada30 participantsStarted 2023-01-15
Plain-language 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.
Who can participate
Age range
65 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was focused on how easy the study devices were to wear and use — rather than on treating back pain itself — so would participating in something like this have actually offered me any direct pain relief, or was it more about collecting data on wearable technology?
2Since this trial has already been completed and it was rated 'Phase NA,' meaning it wasn't testing a new treatment, what kind of research would come next based on what they learned, and is there anything similar I could look into now?
3The trial measured how long people wore the devices and gave usability scores, so would the main commitment have been about tolerating wearing sensors throughout the day, and how realistic would that have been for someone with my daily routine and level of pain?
4Because this study focused on older adults with chronic low back pain and mobility, do you think my age and how my pain affects my movement would have made me a good fit for this type of research, and does that tell us anything useful about my situation?
5Now that this trial is completed, is there any way I or my care team could access what they found about wearable devices for chronic low back pain, and could those findings change how we think about monitoring or managing my pain going forward?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total time and patterns of wearing the study devices
Timeframe: 7 days
2
System Usability Scale (SUS) (ranges from 0 to 100; a higher score indicates better acceptability)