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

NCT ID: NCT04264949

Last Updated: 2024-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-09

Study Completion Date

2023-12-18

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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"

Group Type EXPERIMENTAL

Education in the use of smartphone app (Mon coach dos)

Intervention Type OTHER

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

conventional care

Intervention Type OTHER

conventional care and the therapeutic education program

Groupe conventional care (GCC)

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

Group Type ACTIVE_COMPARATOR

conventional care

Intervention Type OTHER

conventional care and the therapeutic education program

Interventions

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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

Intervention Type OTHER

conventional care

conventional care and the therapeutic education program

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Baptiste Lechauve

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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Chu Clermont Ferrand

Clermont-Ferrand, , France

Site Status

Countries

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France

References

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Lechauve JB, Dobija L, Pereira B, Grolier M, Goldstein A, Lanhers C, Coudeyre E. Evaluation of the impact of a smartphone application on adherence to home exercise program for people with chronic low back pain: research protocol for a pilot randomised controlled trial. BMJ Open. 2023 Mar 24;13(3):e062290. doi: 10.1136/bmjopen-2022-062290.

Reference Type DERIVED
PMID: 36963800 (View on PubMed)

Other Identifiers

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2019-A02191-56

Identifier Type: OTHER

Identifier Source: secondary_id

RBHP 2019 LECHAUVE

Identifier Type: -

Identifier Source: org_study_id

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