The Effect of Accelerometer Guided App Feedback on Change in Activity in Patients With Low Back
The Effect of Accelerometer Guided App Feedback on Change in Activity in Patients With Low Back
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.
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
Inclusion Criteria:

 -  non-specific low back pain, spinal stenosis, radiculopathy

 -  moderate disability or worse (20-100 points on Oswestry Disability Index)

 Exclusion Criteria:

 -  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