The Effect of Accelerometer Guided App Feedback on Change in Activity in Patients With Low Back

NCT04695912 | Completed DMC

• 1 other identifier: H-17010038
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Low Back Pain; Radiculopathy Lumbar; Sciatica

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month

Study Arms (2)

Initial activity tracker with feedback followed by control period

OTHER

Initial activity tracker with feedback followed by control period

Device: The SENS motion® sensor

Initial control period followed by activity tracker with feedback

OTHER

Initial control period followed by activity tracker with feedback

Device: The SENS motion® sensor

Interventions

The SENS motion® sensor DEVICE

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.

Also known as: iSpine app (InterMedCon)

Initial activity tracker with feedback followed by control period; Initial control period followed by activity tracker with feedback

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• non-specific low back pain, spinal stenosis, radiculopathy
• moderate disability or worse (20-100 points on Oswestry Disability Index)

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

COPEBACK, Rigshospitalet

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Low Back Pain; Sciatica

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia

Study Officials

• Anna katrine Itenov, MD

  COPEBACK, Rigshospitalet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: senior registrar, MD

Model Details: crossover, open-label, randomized, controlled trial

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: January 5, 2021
• Study Start: April 26, 2019
• Primary Completion: June 20, 2019
• Study Completion: June 20, 2019
• Last Updated: January 5, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)