NCT04264949

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 11, 2020

Completed
27 days until next milestone

Study Start

First participant enrolled

March 9, 2020

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2023

Completed
Last Updated

February 14, 2024

Status Verified

February 1, 2024

Enrollment Period

3.8 years

First QC Date

February 7, 2020

Last Update Submit

February 13, 2024

Conditions

Chronic Low Back Pain

Keywords

Chronic Low Back PainPhysical activityAdherence

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (11)

  • OSWESTRY questionnaire

    day1, day 15, day 180

  • EPAP questionnaire

    day1, day 15, day 180

  • Pain measurment: numeric scale

    day1, day 15, day 180

  • 6 minutes' walk test (6MWT)

    day1, day 15, day 180

  • aerobic capacities

    day1, day 15, day 180

  • +6 more secondary outcomes

Study Arms (2)

group application (GA)

EXPERIMENTAL

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)Other: conventional care

Groupe conventional care (GCC)

ACTIVE COMPARATOR

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

Other: conventional care

Interventions

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

group application (GA)
conventional careOTHER

conventional care and the therapeutic education program

Groupe conventional care (GCC)group application (GA)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Clermont Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (1)

  • 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.

    PMID: 36963800DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Jean-Baptiste Lechauve

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2020

First Posted

February 11, 2020

Study Start

March 9, 2020

Primary Completion

December 18, 2023

Study Completion

December 18, 2023

Last Updated

February 14, 2024

Record last verified: 2024-02

Locations

FR(1)