Low Back Pain"Chronic pain"NCT05167877
Aging, Mobility and Chronic Low Back Pain
An observational study of Low Back Pain and Chronic Pain, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Chronic Pain
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jan 2023to 15 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Elderly patients without chronic low back pain (CLBP) for control group, and elderly patients with CLBP for active group.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Low Back Pain, Chronic Pain
- Being tested
- No intervention will be given to the participants
- Keywords
- Low Back Pain, Chronic, Older Adults, Mobility, Remote Monitoring
- Medical subject headings
- Low Back Pain, Chronic Pain, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention will be given to the participantsOther
This is an observational feasibility study with no intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: No intervention will be given to the participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: On Day 7
Secondary outcomes (5)
Back Performance Scale (BPS) (range from 0 to 15; a higher score indicates worse performance)
The association between BPS measured at baseline and chronic low back pain will be assessed.
Measured: At baseline
Self-paced walking test
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.
Measured: At baseline
Neurophysiological markers
The association between the neurophysiological markers measured from transcranial magnetic stimulation at baseline and chronic low back pain will be assessed.
Measured: At baseline
Gait and physical activity
The association between the physical activity measured using remote monitoring during the study period and chronic low back pain will be assessed.
Measured: 7 days
Subgroups of chronic low back pain (CLBP)
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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start15 Jan 2023
- Primary completion14 Feb 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton
- Responsible party
- Sponsor
- Investigators
- Harsha Shanthanna, MD, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167877
- Sponsor's protocol ID
- 21-011
- Acronym
- "Chronic pain"
- Status last verified
- Mar 2024
- First submitted
- 15 Nov 2021
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31664424Wong 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.
PubMed 28435906Deyo RA, Weinstein JN. Low back pain. N Engl J Med. 2001 Feb 1;344(5):363-70. doi: 10.1056/NEJM200102013440508. No abstract available.
PubMed 11172169Alsufiany 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.
PubMed 32000363Pinto 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.
PubMed 24577780Amorim 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.
PubMed 30744606Corbett 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.
PubMed 30371555Hodges 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.
PubMed 24709625Kosek 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.
PubMed 23973144Thomas 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.
PubMed 12364304Vincent 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.
PubMed 23478452Holden 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.
PubMed 22511582Nijs 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.
PubMed 22786458Hurwitz 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.
PubMed 16186460Hoffman 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.
PubMed 21256073
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studying Aging, Mobility and Chronic Low Back Pain in Older Adults Using Remote Monitoring
- ClinicalTrials.gov ID
- NCT05167877
- Acronym / sponsor ID
- "Chronic pain" / 21-011
- Conditions
- Low Back Pain, Chronic Pain
- Keywords
- Low Back Pain, Chronic, Older Adults, Mobility, Remote Monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 14 Feb 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 22 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Other: No intervention will be given to the participantsParticipants 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. |
| Active group | – | Other: No intervention will be given to the participantsParticipants 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. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Elderly patients without chronic low back pain (CLBP) for control group, and elderly patients with CLBP for active group.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention will be given to the participantsThis is an observational feasibility study with no intervention. | Other | Active group, Control group |
Primary outcome
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.
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.
5 secondary outcomes
Back Performance Scale (BPS) (range from 0 to 15; a higher score indicates worse performance)
Time frame: At baseline
Self-paced walking test
Time frame: At baseline
Neurophysiological markers
Time frame: At baseline
Gait and physical activity
Time frame: 7 days
Subgroups of chronic low back pain (CLBP)
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Results publication: PubMed 31664424de 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.
- Results publication: PubMed 28435906Wong 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.
- Results publication: PubMed 11172169Deyo RA, Weinstein JN. Low back pain. N Engl J Med. 2001 Feb 1;344(5):363-70. doi: 10.1056/NEJM200102013440508. No abstract available.
- Results publication: PubMed 32000363Alsufiany 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.
- Results publication: PubMed 24577780Pinto 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.
- Results publication: PubMed 30744606Amorim 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.
- Results publication: PubMed 30371555Corbett 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.
- Results publication: PubMed 24709625Hodges 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.
- Results publication: PubMed 23973144Kosek 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.
- Results publication: PubMed 12364304Thomas 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.
- Results publication: PubMed 23478452Vincent 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.
- Results publication: PubMed 22511582Holden 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.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
Not yet recruitingPhase 3
Veterans' Intervention Blending NeuRomodulation and YogA for Chronic Low BackPaiN Treatment: VIBRANT
Chronic Low Back Pain, Musculoskeletal Pain
Not yet recruitingPhase 2
Psilocybin-Assisted Physical Therapy in Chronic Low Back Pain
Chronic Low Back Pain (CLBP), Physical Therapy
Not yet recruitingPhase 2/3
PRP Versus NP Injections for Chronic Discogenic Low Back Pain
Discogenic Low Back Pain
Not yet recruiting
Dual-Task Core Stabilization Training in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low Back Pain
Not yet recruiting
Gamified Home-Based Core Neuromuscular Training for Chronic Low Back Pain
Low Back Pain, Core Muscles
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harsha Shanthanna, MD, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain and Chronic Pain, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total time and patterns of wearing the study devices (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05167877, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.