Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04695912 |
| Other study ID # |
H-17010038 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 26, 2019 |
| Est. completion date |
June 20, 2019 |
Study information
| Verified date |
January 2021 |
| Source |
Rigshospitalet, Denmark |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
1. 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.
2. 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.
3. 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
