Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
ACTIVE_NOT_RECRUITING
Total Enrollment
30 participants
Study Classification
OBSERVATIONAL
Study Start Date
2023-01-15
Study Completion Date
2024-12-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Functional Rehabilitation Effects on Exercise-induced Hypoalgesia in Chronic Low Back Pain
NCT07347457
Low Back Pain
ENROLLING_BY_INVITATION
NA
Predictive Factors for the Success of Rehabilitation Programs in Chronic Low Back Pain
NCT07051772
Low Back Pain
RECRUITING
Motivations, Obstacles and Opportunities for Using a Health Application to Encourage Physical Activity in People With Chronic Low Back Pain
NCT06517342
Chronic Low-back Pain
RECRUITING
Motivational Support Program in Chronic Low Back Pain After Multidisciplinary Functional Rehabilitation
NCT05780021
Chronic Low-back Pain
RECRUITING
NA
Aging Successfully With Pain
NCT01405716
Low Back Pain
COMPLETED
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Low Back Pain
Chronic Pain
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
No intervention will be given to the participants
Intervention Type
OTHER
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.
No intervention will be given to the participants
Intervention Type
OTHER
This is an observational feasibility study with no intervention.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
No intervention will be given to the participants
This is an observational feasibility study with no intervention.
Intervention Type
OTHER
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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
* 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
* 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
Minimum Eligible Age
65 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
St. Joseph's Healthcare Hamilton
OTHER
Sponsor Role
collaborator
McMaster University
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Harsha Shanthanna, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Canada
References
Explore related publications, articles, or registry entries linked to this study.
de Souza IMB, Sakaguchi TF, Yuan SLK, Matsutani LA, do Espirito-Santo AS, Pereira CAB, Marques AP. Prevalence of low back pain in the elderly population: a systematic review. Clinics (Sao Paulo). 2019 Oct 28;74:e789. doi: 10.6061/clinics/2019/e789. eCollection 2019.
Reference Type
RESULT
Wong AYL, Karppinen J, Samartzis D. Low back pain in older adults: risk factors, management options and future directions. Scoliosis Spinal Disord. 2017 Apr 18;12:14. doi: 10.1186/s13013-017-0121-3. eCollection 2017.
Reference Type
RESULT
Deyo RA, Weinstein JN. Low back pain. N Engl J Med. 2001 Feb 1;344(5):363-70. doi: 10.1056/NEJM200102013440508. No abstract available.
Reference Type
RESULT
Alsufiany MB, Lohman EB, Daher NS, Gang GR, Shallan AI, Jaber HM. Non-specific chronic low back pain and physical activity: A comparison of postural control and hip muscle isometric strength: A cross-sectional study. Medicine (Baltimore). 2020 Jan;99(5):e18544. doi: 10.1097/MD.0000000000018544.
Reference Type
RESULT
Pinto RZ, Ferreira PH, Kongsted A, Ferreira ML, Maher CG, Kent P. Self-reported moderate-to-vigorous leisure time physical activity predicts less pain and disability over 12 months in chronic and persistent low back pain. Eur J Pain. 2014 Sep;18(8):1190-8. doi: 10.1002/j.1532-2149.2014.00468.x. Epub 2014 Feb 27.
Reference Type
RESULT
Amorim AB, Pappas E, Simic M, Ferreira ML, Jennings M, Tiedemann A, Carvalho-E-Silva AP, Caputo E, Kongsted A, Ferreira PH. Integrating Mobile-health, health coaching, and physical activity to reduce the burden of chronic low back pain trial (IMPACT): a pilot randomised controlled trial. BMC Musculoskelet Disord. 2019 Feb 11;20(1):71. doi: 10.1186/s12891-019-2454-y.
Reference Type
RESULT
Corbett DB, Simon CB, Manini TM, George SZ, Riley JL 3rd, Fillingim RB. Movement-evoked pain: transforming the way we understand and measure pain. Pain. 2019 Apr;160(4):757-761. doi: 10.1097/j.pain.0000000000001431. No abstract available.
Reference Type
RESULT
Hodges PW, Smeets RJ. Interaction between pain, movement, and physical activity: short-term benefits, long-term consequences, and targets for treatment. Clin J Pain. 2015 Feb;31(2):97-107. doi: 10.1097/AJP.0000000000000098.
Reference Type
RESULT
Kosek E, Roos EM, Ageberg E, Nilsdotter A. Increased pain sensitivity but normal function of exercise induced analgesia in hip and knee osteoarthritis--treatment effects of neuromuscular exercise and total joint replacement. Osteoarthritis Cartilage. 2013 Sep;21(9):1299-307. doi: 10.1016/j.joca.2013.06.019.
Reference Type
RESULT
Thomas KS, Muir KR, Doherty M, Jones AC, O'Reilly SC, Bassey EJ. Home based exercise programme for knee pain and knee osteoarthritis: randomised controlled trial. BMJ. 2002 Oct 5;325(7367):752. doi: 10.1136/bmj.325.7367.752.
Reference Type
RESULT
Vincent HK, Seay AN, Montero C, Conrad BP, Hurley RW, Vincent KR. Kinesiophobia and fear-avoidance beliefs in overweight older adults with chronic low-back pain: relationship to walking endurance--part II. Am J Phys Med Rehabil. 2013 May;92(5):439-45. doi: 10.1097/PHM.0b013e318287633c.
Reference Type
RESULT
Holden MA, Nicholls EE, Young J, Hay EM, Foster NE. Role of exercise for knee pain: what do older adults in the community think? Arthritis Care Res (Hoboken). 2012 Oct;64(10):1554-64. doi: 10.1002/acr.21700.
Reference Type
RESULT
Nijs J, Kosek E, Van Oosterwijck J, Meeus M. Dysfunctional endogenous analgesia during exercise in patients with chronic pain: to exercise or not to exercise? Pain Physician. 2012 Jul;15(3 Suppl):ES205-13.
Reference Type
RESULT
Hurwitz EL, Morgenstern H, Chiao C. Effects of recreational physical activity and back exercises on low back pain and psychological distress: findings from the UCLA Low Back Pain Study. Am J Public Health. 2005 Oct;95(10):1817-24. doi: 10.2105/AJPH.2004.052993.
Reference Type
RESULT
Hoffman SL, Johnson MB, Zou D, Harris-Hayes M, Van Dillen LR. Effect of classification-specific treatment on lumbopelvic motion during hip rotation in people with low back pain. Man Ther. 2011 Aug;16(4):344-50. doi: 10.1016/j.math.2010.12.007. Epub 2011 Jan 20.
Reference Type
RESULT
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.
Reference Type
RESULT
Thibaut A, Zeng D, Caumo W, Liu J, Fregni F. Corticospinal excitability as a biomarker of myofascial pain syndrome. Pain Rep. 2017 Apr 18;2(3):e594. doi: 10.1097/PR9.0000000000000594. eCollection 2017 May.
Reference Type
RESULT
Chaves AR, Snow NJ, Alcock LR, Ploughman M. Probing the Brain-Body Connection Using Transcranial Magnetic Stimulation (TMS): Validating a Promising Tool to Provide Biomarkers of Neuroplasticity and Central Nervous System Function. Brain Sci. 2021 Mar 17;11(3):384. doi: 10.3390/brainsci11030384.
Reference Type
RESULT
Knell G, Gabriel KP, Businelle MS, Shuval K, Wetter DW, Kendzor DE. Ecological Momentary Assessment of Physical Activity: Validation Study. J Med Internet Res. 2017 Jul 18;19(7):e253. doi: 10.2196/jmir.7602.
Reference Type
RESULT
Majumder S, Mondal T, Deen MJ. A Simple, Low-Cost and Efficient Gait Analyzer for Wearable Healthcare Applications. IEEE Sensors Journal. 2019;19(6):2320-2329.
Reference Type
RESULT
Jin B, Thu TH, Baek E, Sakong S, Xiao J, Mondal T, Deen MJ. Walking-age analyzer for healthcare applications. IEEE J Biomed Health Inform. 2014 May;18(3):1034-42. doi: 10.1109/JBHI.2013.2296873.
Reference Type
RESULT
Bennett MI, Smith BH, Torrance N, Potter J. The S-LANSS score for identifying pain of predominantly neuropathic origin: validation for use in clinical and postal research. J Pain. 2005 Mar;6(3):149-58. doi: 10.1016/j.jpain.2004.11.007.
Reference Type
RESULT
Deyo RA, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E, Carrino J, Chou R, Cook K, Delitto A, Goertz C, Khalsa P, Loeser J, Mackey S, Panagis J, Rainville J, Tosteson T, Turk D, Von Korff M, Weiner DK. Report of the NIH Task Force on research standards for chronic low back pain. Phys Ther. 2015 Feb;95(2):e1-e18. doi: 10.2522/ptj.2015.95.2.e1.
Reference Type
RESULT
Huang W, Rose AJ, Bayliss E, Baseman L, Butcher E, Garcia RE, Edelen MO. Adapting summary scores for the PROMIS-29 v2.0 for use among older adults with multiple chronic conditions. Qual Life Res. 2019 Jan;28(1):199-210. doi: 10.1007/s11136-018-1988-z. Epub 2018 Sep 12.
Reference Type
RESULT
Deyo RA, Katrina Ramsey, Buckley DI, Michaels L, Kobus A, Eckstrom E, Forro V, Morris C. Performance of a Patient Reported Outcomes Measurement Information System (PROMIS) Short Form in Older Adults with Chronic Musculoskeletal Pain. Pain Med. 2016 Feb;17(2):314-24. doi: 10.1093/pm/pnv046.
Reference Type
RESULT
Nicholas MK. The pain self-efficacy questionnaire: Taking pain into account. Eur J Pain. 2007 Feb;11(2):153-63. doi: 10.1016/j.ejpain.2005.12.008. Epub 2006 Jan 30.
Reference Type
RESULT
Davidson M, Keating JL. A comparison of five low back disability questionnaires: reliability and responsiveness. Phys Ther. 2002 Jan;82(1):8-24. doi: 10.1093/ptj/82.1.8.
Reference Type
RESULT
Strand LI, Moe-Nilssen R, Ljunggren AE. Back Performance Scale for the assessment of mobility-related activities in people with back pain. Phys Ther. 2002 Dec;82(12):1213-23.
Reference Type
RESULT
Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J; IMMPACT. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005 Jan;113(1-2):9-19. doi: 10.1016/j.pain.2004.09.012. No abstract available.
Reference Type
RESULT
Kim E, Lovera J, Schaben L, Melara J, Bourdette D, Whitham R. Novel method for measurement of fatigue in multiple sclerosis: Real-Time Digital Fatigue Score. J Rehabil Res Dev. 2010;47(5):477-84. doi: 10.1682/jrrd.2009.09.0151.
Reference Type
RESULT
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.
Reference Type
RESULT
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
21-011
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
The Effect of Reducing Sedentary Behaviour in Comparison to Promoting Physical Activity on Chronic Non-specific Low Back Pain in a Sedentary Population
NCT04610905
TERMINATED
NA
Immediate Exercise-Induced Hypoalgesia in Patients With Chronic Low Back Pain
NCT05077566
COMPLETED
NA
Online Physical Exercise for Chronic Low Back Pain
NCT05895630
COMPLETED
NA
Exploring Physiotherapist's Knowledge, Attitudes, Beliefs and Clinical Decision-making Regarding Physical Activity in Chronic Pain Management.
NCT06605729
RECRUITING
NA
Effects of Motivational Interviewing on Self-Efficacy and Standardized Low Back Pain Outcomes in Patients With Chronic Back Pain"
NCT00170118
COMPLETED
NA
Motivation and Adherence to Exercise Recommendations
NCT05512338
COMPLETED
NA
Efficacy of Passive Joint Mobilization vs Mobilization With Movement on Pain Processing in Patients With Chronic Low Back Pain
NCT04940715
UNKNOWN
NA
Evolution of Physical Activity, Sedentary Behavior and Associated Motivations After Rehabilitation for Chronic Low Back Pain Patients
NCT05404854
COMPLETED
Interoceptive Awareness, Physical Activity, Body Awareness and Emotional Status in Individuals With Non-Specific Chronic Low Back Pain
NCT07275255
NOT_YET_RECRUITING
Reducing Sedentary Time in Chronic Low Back Pain: Sedentary Intervention Using Motivational Interviewing and Technology
NCT04257539
COMPLETED
NA
Home-based Exercise Rehabilitation With a Novel Digital Biofeedback System for Chronic Low Back Pain
NCT04401683
WITHDRAWN
NA
Feasibility and Effect of a Multidisciplinary Telematics Approach for Chronic Non-specific Low Back Pain: a Randomized, Open-label, Controlled, Pilot Clinical Trial. Study Protocol
NCT05093543
COMPLETED
NA
Chronic Low Back Pain: A Multidisciplinary Approach
NCT01993355
COMPLETED
NA
Telecare Rehabilitation Program in Chronic Low Back Pain with Psychological Retention and Predominant Sociability
NCT05390762
COMPLETED
NA
Effect of Physiotherapeutic Interventions on Quality of Life in Patients With Chronic Low Back Pain. (Study 1)
NCT03322956
COMPLETED
NA
Effects of a Land and Aquatic Exercise-based Program on Pain, Mobility and Quality of Life in Patients With Chronic Low Back Pain
NCT06641570
COMPLETED
NA
Behavioral Indicators of Pain Representation
NCT06669767
COMPLETED
A Study Protocol Comparing a Home Rehabilitation Program Versus e-Health Program in Low Back Pain
NCT04283370
COMPLETED
NA
Preventing Chronicity of Sub-acute Low Back Pain by Altering the Neural Emotional Response to Pain
NCT05450263
WITHDRAWN
NA
Effect of Physiotherapeutic Interventions on Quality of Life in Patients With Chronic Low Back Pain. (Study 2)
NCT03309540
UNKNOWN
NA
Efficacy of Two Physiotherapy's Approaches in Chronic Low Back Pain: Is Addressing Psychosocial Factors Beneficial?
NCT04979403
COMPLETED
NA
Coping Skills Training for Living With Chronic Low Back Pain
NCT02478307
COMPLETED
PHASE1/PHASE2
Back to Living Well: Implementation of a Community-based Program for Low Back Pain
NCT05929846
RECRUITING
Exercise Therapy for Recurrent Low Back Pain: Unraveling the Puzzle of Peripheral Muscle and Central Brain Changes (B670201420984)
NCT05706103
RECRUITING
NA
Spinal Kinematics Variability
NCT03507296
COMPLETED