E-lombactifs: Evaluation of the Impact a Smartphone Application on Adherence an Exercise Program in Chronic Low Back Pain (E-lombactifs)

The main objective is to assess the impact of smartphone application on adherence to a physical exercise program in chronic low back pain patients.

Adherence to a physical exercise program will be assessed at the start of the protocol, at three weeks and six months.

A control group will benefit from conventional care in a rehabilitation center and an intervention group will benefit from a conventional care in a rehabilitation center accompanied by education in the use of a smartphone application including physical exercises and information about low back pain.

The hypothesis of the search is that adherence is better in intervention group than control group at 6 months due to education in the use of smartphone application.

Study Overview

• Status: Completed
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Other: Education in the use of smartphone app (Mon coach dos); Other: conventional care

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • CHU Clermont Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult People
• With nonspecific chronic low back pain (according to the definition of the HAS)
• Covered under the national health insurance
• Giving informed written consent to participate in the study

Exclusion Criteria:

• Patient who do not meet the diagnostic criteria according to the definition of HAS
• Behavioral disorders or comprehension difficulties making assessment impossible
• Patient with a contraindication to physical exercise for medical reasons
• Patient under guardianship, curatorship or safeguard of justice

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group application (GA); benefit from conventional care in a rehabilitation center, therapeutic education program and education in the use of the smartphone application "mon coach dos"	Other: Education in the use of smartphone app (Mon coach dos); In addition to conventional care and the therapeutic education program, GA will benefit from three education sessions (one per week) on the use of the smartphone app mon coach dos; Other: conventional care; conventional care and the therapeutic education program
Active Comparator: Groupe conventional care (GCC); benefit from conventional care in a rehabilitation center and therapeutic education program	Other: conventional care; conventional care and the therapeutic education program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EARS : exercise adherence rating scale	EARS assess the adherence in physical activity program.	day1
EARS : exercise adherence rating scale	EARS assess the adherence in physical activity program.	day 15
EARS : exercise adherence rating scale	EARS assess the adherence in physical activity program.	day 180

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OSWESTRY questionnaire	Disability is measured by OSWESTRY	day1, day 15, day 180
EPAP questionnaire	The perceived barriers to and facilitators of physical activity are measured by EPAP	day1, day 15, day 180
Pain measurment: numeric scale	The pain is measured by numeric scale	day1, day 15, day 180
6 minutes' walk test (6MWT)	Aerobic and functional capacities are measured by 6 minutes' walk test (6MWT)	day1, day 15, day 180
aerobic capacities	aerobic capacities are measured by sub maximal ergocycle test	day1, day 15, day 180
muscular endurance	the muscular endurance of the erector muscles of the spine is measured by Sorensen test	day1, day 15, day 180
muscular endurance of the flexor muscles of the spine	the muscular endurance of the flexor muscles of the spine is measured by ITO test	day1, day 15, day 180
muscular endurance of the extensor of the knee	the muscular endurance of the extensor of the knee is measured by Killy test	day1, day 15, day 180
Core measurment	Core is measured by plank test	day1, day 15, day 180
Flexibility on posterior chain	Flexibility on posterior chain is measured by DDS test	day1, day 15, day 180
Mobility on posterior chain	Mobility on posterior chain is measured by Schober test	day1, day 15, day 180

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Jean-Baptiste Lechauve, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2020
• Primary Completion (Actual): December 18, 2023
• Study Completion (Actual): December 18, 2023

Study Registration Dates

• First Submitted: February 7, 2020
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (Actual): February 11, 2020

Study Record Updates

• Last Update Posted (Estimated): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Adherence; Physical activity; Chronic Low Back Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: RBHP 2019 LECHAUVE; 2019-A02191-56 (Other Identifier: 2019-A02191-56)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No