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

Primary Purpose

Chronic Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Education in the use of smartphone app (Mon coach dos)
conventional care
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Chronic Low Back Pain, Physical activity, Adherence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chu Clermont FerrandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

group application (GA)

Groupe conventional care (GCC)

Arm Description

benefit from conventional care in a rehabilitation center, therapeutic education program and education in the use of the smartphone application "mon coach dos"

benefit from conventional care in a rehabilitation center and therapeutic education program

Outcomes

Primary Outcome Measures

EARS : exercise adherence rating scale
EARS assess the adherence in physical activity program.
EARS : exercise adherence rating scale
EARS assess the adherence in physical activity program.
EARS : exercise adherence rating scale
EARS assess the adherence in physical activity program.

Secondary Outcome Measures

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

Full Information

First Posted
February 7, 2020
Last Updated
November 21, 2022
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT04264949
Brief Title
E-lombactifs: Evaluation of the Impact a Smartphone Application on Adherence an Exercise Program in Chronic Low Back Pain
Acronym
E-lombactifs
Official Title
E-lombactifs: Evaluation of the Impact a Smartphone Application on Adherence an Exercise Program in Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
Chronic Low Back Pain, Physical activity, Adherence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group application (GA)
Arm Type
Experimental
Arm Description
benefit from conventional care in a rehabilitation center, therapeutic education program and education in the use of the smartphone application "mon coach dos"
Arm Title
Groupe conventional care (GCC)
Arm Type
Active Comparator
Arm Description
benefit from conventional care in a rehabilitation center and therapeutic education program
Intervention Type
Other
Intervention Name(s)
Education in the use of smartphone app (Mon coach dos)
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
conventional care
Intervention Description
conventional care and the therapeutic education program
Primary Outcome Measure Information:
Title
EARS : exercise adherence rating scale
Description
EARS assess the adherence in physical activity program.
Time Frame
day1
Title
EARS : exercise adherence rating scale
Description
EARS assess the adherence in physical activity program.
Time Frame
day 15
Title
EARS : exercise adherence rating scale
Description
EARS assess the adherence in physical activity program.
Time Frame
day 180
Secondary Outcome Measure Information:
Title
OSWESTRY questionnaire
Description
Disability is measured by OSWESTRY
Time Frame
day1, day 15, day 180
Title
EPAP questionnaire
Description
The perceived barriers to and facilitators of physical activity are measured by EPAP
Time Frame
day1, day 15, day 180
Title
Pain measurment: numeric scale
Description
The pain is measured by numeric scale
Time Frame
day1, day 15, day 180
Title
6 minutes' walk test (6MWT)
Description
Aerobic and functional capacities are measured by 6 minutes' walk test (6MWT)
Time Frame
day1, day 15, day 180
Title
aerobic capacities
Description
aerobic capacities are measured by sub maximal ergocycle test
Time Frame
day1, day 15, day 180
Title
muscular endurance
Description
the muscular endurance of the erector muscles of the spine is measured by Sorensen test
Time Frame
day1, day 15, day 180
Title
muscular endurance of the flexor muscles of the spine
Description
the muscular endurance of the flexor muscles of the spine is measured by ITO test
Time Frame
day1, day 15, day 180
Title
muscular endurance of the extensor of the knee
Description
the muscular endurance of the extensor of the knee is measured by Killy test
Time Frame
day1, day 15, day 180
Title
Core measurment
Description
Core is measured by plank test
Time Frame
day1, day 15, day 180
Title
Flexibility on posterior chain
Description
Flexibility on posterior chain is measured by DDS test
Time Frame
day1, day 15, day 180
Title
Mobility on posterior chain
Description
Mobility on posterior chain is measured by Schober test
Time Frame
day1, day 15, day 180

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise Laclautre
Phone
334.73.754.963
Email
promo_interne_drci@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Baptiste Lechauve
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Clermont Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
Email
promo_interne_drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Jean-Baptiste Lechauve

12. IPD Sharing Statement

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

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