Low Back PainNCT04695912
The Effect of Accelerometer Guided App Feedback on Change in Activity in Patients With Low Back
A study testing The SENS motion® sensor in people with Low Back Pain and Radiculopathy Lumbar, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
In a cross-over, open-label, randomized, controlled trial, the investigators aim to determine if the daily activity level in patients with LBP can be increased via feedback from an app, connected to a wearable sensor of physical activity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Radiculopathy Lumbar, Sciatica
- What is being tested?
- The SENS motion® sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteDenmark
- Study dates
- 26 Apr 2019to 20 Jun 2019
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- non-specific low back pain, spinal stenosis, radiculopathy
- moderate disability or worse (20-100 points on Oswestry Disability Index)
Who cannot join
- co-morbidity making the patients unable to move
- unsufficient Danish-skills
- patients who already monitored their activity by watch or phone on a daily basis
- allergy to band-aid
- pregnancy or breast-feeding
- patients referred for back-surgical evaluation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Accelerometer Guided App Feedback on Change in Activity in Patients With Low Back Pain
In a cross-over, open-label, randomized, controlled trial, the investigators aim to determine if the daily activity level in patients with LBP can be increased via feedback from an app, connected to a wearable sensor of physical activity.
Read the detailed description
The aim of the study is to determine if a wearable device that measure physical activity and a smartphone application with nudges and feedback increase the physical activity level of patients with low back pain over a 14 days period.
Secondary to determine how many of the patients, that use the smartphone application, and if they perceived the feedback as inspiring.
And to explore, if a potential effect of the device and smartphone application depended on the baseline activity level, gender, diagnoses, age, education level and previous exercise experience.
- Is there a difference in average (mean) daily number of active minutes (defined as walking, cycling, running or exercise) over the 14 days intervention period compared to the 14 days control period.
- If there is an effect of the device and smartphone application, then determine how many of the patients, that use the smartphone application, and if they perceived the feedback as inspiring. To explore, if a potential effect of the device and smartphone application depended on the baseline activity level, gender, diagnoses, age, education level and previous exercise experience.
- Is the outcome measures; function measured by sensor, the subjective measurements as pain, stiffness and function, responsive to the intervention compared, to the global scale. 4. Is the patient´s self-evaluated change in activity in the intervention period compared to the baseline period and the control period corelated to the changes in activity measured by the sensor.
The investigators will make a Cross-over, randomized, open label, controlled trial.
Patients will be included from the outpatient clinic, The Department of Rheumatology, Rigshospitalet - Glostrup, Region Hovedstaden, Denmark Inclusions criteria
- Aged 18 years or older
- Non-specific low back pain, spinal stenosis or radiculopathy.
- Not referred for surgical evaluation.
- Patients who scored ≥ 20 point at the Oswestry Disability Index Exclusion criteria
- Patients with comorbidity that prevent them for participating in the study.
- Patients who are judge by the principal investigator to not speak Danish sufficiently to enable them to comprehend the study information and app feedback.
- Patients who already monitor their activity by a watch, on a daily basis.
- Patients with allergy for band aid
- Patients who are pregnant or breastfeeding
The patients are randomized to start with intervention + standard-of-care or only standard-of-care. After completion of the first period the patients will cross-over to the other period.
The patients are randomized by closed envelope. Using a randomization list from randomization.com.
Intervention period
The patients wear the SENS motion patch for 14 days and received daily updates on activity, and suggestions for improvements. During the intervention period the patients receive standard-of-care.
Control period
The patients wear the SENS motion patch for 14 days, but do not receive any feedback from the sensor. During the control period the patients receive standard-of-care.
Standard-of-care
At the outpatient clinic patients are examined by a doctor, receive a diagnosis and may undergo MRI to identify other causes for back pain. They are not offered any training program at the hospital, but they are recommended to stay active and exercise. Some may have a consultation with a physiotherapist one to two times who repeat the advice. Patients are informed that despite pain, they cannot harm their spine by work, exercise or performing daily activities, and that medical staff do not discourage any activities.
Name of the investigational device
SENS motion®, SENS-Innovation ApS
Titangade 11, 2. - 2200 Kbh. N.
Sensor
The SENS motion® system consists of:
- The sensor 'SENS Motion Patch'
- A smart-phone application 'SENS motion´
- SENS motion cloud storage database, a web-based visualization of data for the healthcare team
- Conditions
- Low Back Pain, Radiculopathy Lumbar, Sciatica
- Being tested
- The SENS motion® sensor
- Medical subject headings
- Low Back Pain, Sciatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The SENS motion® sensorDevice
Also called iSpine app (InterMedCon)
The sensor is a wearable physical tracker giving investigators feedback about daily activity
The SENS motion® system consists of:
The sensor 'SENS Motion Patch' A smart-phone application 'SENS motion´
SENS motion cloud storage database, a web-based visualization of data for the healthcare team
The iSpine app shows activity-information recorded by the sensor to the patient and gives nudges to activity.
| Study group | Role | What they receive |
|---|---|---|
| Initial activity tracker with feedback followed by control period | Other | Initial activity tracker with feedback followed by control period Receives: Device: The SENS motion® sensor |
| Initial control period followed by activity tracker with feedback | Other | Initial control period followed by activity tracker with feedback Receives: Device: The SENS motion® sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average daily activity
The Primary outcome was defined as the difference in average (mean) daily number of minutes in activity (defined as the sum of time spent with standing, walking, cycling and exercising) in 14 days intervention period compared to 14 days control period, registered by the sensor.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start26 Apr 2019
- Primary completion20 Jun 2019
- Study completion20 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- crossover, open-label, randomized, controlled trial
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Katrine Skovsgaard Itenov, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Anna katrine Itenov, MD, Principal investigator, COPEBACK, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04695912
- Sponsor's protocol ID
- H-17010038
- Status last verified
- Jan 2021
- First submitted
- 8 Dec 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Accelerometer Guided App Feedback on Change in Activity in Patients With Low Back Pain
- ClinicalTrials.gov ID
- NCT04695912
- Acronym / sponsor ID
- H-17010038
- Conditions
- Low Back Pain, Radiculopathy Lumbar, Sciatica
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 26 Apr 2019 (actual)
- Primary completion
- 20 Jun 2019 (actual)
- Study completion
- 20 Jun 2019 (actual)
- First posted
- 5 Jan 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.
In a cross-over, open-label, randomized, controlled trial, the investigators aim to determine if the daily activity level in patients with LBP can be increased via feedback from an app, connected to a wearable sensor of physical activity.
Detailed description
The aim of the study is to determine if a wearable device that measure physical activity and a smartphone application with nudges and feedback increase the physical activity level of patients with low back pain over a 14 days period.
Secondary to determine how many of the patients, that use the smartphone application, and if they perceived the feedback as inspiring.
And to explore, if a potential effect of the device and smartphone application depended on the baseline activity level, gender, diagnoses, age, education level and previous exercise experience.
- Is there a difference in average (mean) daily number of active minutes (defined as walking, cycling, running or exercise) over the 14 days intervention period compared to the 14 days control period.
- If there is an effect of the device and smartphone application, then determine how many of the patients, that use the smartphone application, and if they perceived the feedback as inspiring. To explore, if a potential effect of the device and smartphone application depended on the baseline activity level, gender, diagnoses, age, education level and previous exercise experience.
- Is the outcome measures; function measured by sensor, the subjective measurements as pain, stiffness and function, responsive to the intervention compared, to the global scale. 4. Is the patient´s self-evaluated change in activity in the intervention period compared to the baseline period and the control period corelated to the changes in activity measured by the sensor.
The investigators will make a Cross-over, randomized, open label, controlled trial.
Patients will be included from the outpatient clinic, The Department of Rheumatology, Rigshospitalet - Glostrup, Region Hovedstaden, Denmark Inclusions criteria
- Aged 18 years or older
- Non-specific low back pain, spinal stenosis or radiculopathy.
- Not referred for surgical evaluation.
- Patients who scored ≥ 20 point at the Oswestry Disability Index Exclusion criteria
- Patients with comorbidity that prevent them for participating in the study.
- Patients who are judge by the principal investigator to not speak Danish sufficiently to enable them to comprehend the study information and app feedback.
- Patients who already monitor their activity by a watch, on a daily basis.
- Patients with allergy for band aid
- Patients who are pregnant or breastfeeding
The patients are randomized to start with intervention + standard-of-care or only standard-of-care. After completion of the first period the patients will cross-over to the other period.
The patients are randomized by closed envelope. Using a randomization list from randomization.com.
Intervention period
The patients wear the SENS motion patch for 14 days and received daily updates on activity, and suggestions for improvements. During the intervention period the patients receive standard-of-care.
Control period
The patients wear the SENS motion patch for 14 days, but do not receive any feedback from the sensor. During the control period the patients receive standard-of-care.
Standard-of-care
At the outpatient clinic patients are examined by a doctor, receive a diagnosis and may undergo MRI to identify other causes for back pain. They are not offered any training program at the hospital, but they are recommended to stay active and exercise. Some may have a consultation with a physiotherapist one to two times who repeat the advice. Patients are informed that despite pain, they cannot harm their spine by work, exercise or performing daily activities, and that medical staff do not discourage any activities.
Name of the investigational device
SENS motion®, SENS-Innovation ApS
Titangade 11, 2. - 2200 Kbh. N.
Sensor
The SENS motion® system consists of:
- The sensor 'SENS Motion Patch'
- A smart-phone application 'SENS motion´
- SENS motion cloud storage database, a web-based visualization of data for the healthcare team
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- crossover, open-label, randomized, controlled trial
| Arm | Type | Receives |
|---|---|---|
| Initial activity tracker with feedback followed by control period | Other | Device: The SENS motion® sensorInitial activity tracker with feedback followed by control period |
| Initial control period followed by activity tracker with feedback | Other | Device: The SENS motion® sensorInitial control period followed by activity tracker with feedback |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- non-specific low back pain, spinal stenosis, radiculopathy
- moderate disability or worse (20-100 points on Oswestry Disability Index)
Key exclusion criteria (6 listed)
- co-morbidity making the patients unable to move
- unsufficient Danish-skills
- patients who already monitored their activity by watch or phone on a daily basis
- allergy to band-aid
- pregnancy or breast-feeding
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 |
|---|---|---|
| The SENS motion® sensorAlso: iSpine app (InterMedCon)The sensor is a wearable physical tracker giving investigators feedback about daily activity The SENS motion® system consists of: The sensor 'SENS Motion Patch' A smart-phone application 'SENS motion´ SENS motion cloud storage database, a web-based visualization of data for the healthcare team The iSpine app shows activity-information recorded by the sensor to the patient and gives nudges to activity. | Device | Initial activity tracker with feedback followed by control period, Initial control period followed by activity tracker with feedback |
Primary outcome
Average daily activity
Time frame: 1 month
The Primary outcome was defined as the difference in average (mean) daily number of minutes in activity (defined as the sum of time spent with standing, walking, cycling and exercising) in 14 days intervention period compared to 14 days control period, registered by the sensor.
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 5 Jan 2021.
- Individual participant dataSharing planned: No
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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.
Anna katrine Itenov, MD principal investigator
COPEBACK, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The SENS motion® sensor in people with Low Back Pain and Radiculopathy Lumbar, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 2 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 5 Jan 2021. 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 Denmark. 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?
Average daily activity (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2021.