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Completed

NCT Number: NCT04264949

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

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.

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Key information

Conditions

Chronic Low Back Pain Behavior Motor Activity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Clermont Ferrand

Clermont-Ferrand, 63003, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Conventional care

Other

conventional care and the therapeutic education program

Primary outcomes

  1. EARS : exercise adherence rating scale

    Time frame: day1

    EARS assess the adherence in physical activity program.

  2. EARS : exercise adherence rating scale

    Time frame: day 15

    EARS assess the adherence in physical activity program.

  3. EARS : exercise adherence rating scale

    Time frame: day 180

    EARS assess the adherence in physical activity program.

Secondary outcomes

  1. OSWESTRY questionnaire

    Time frame: day1, day 15, day 180

    Disability is measured by OSWESTRY

  2. EPAP questionnaire

    Time frame: day1, day 15, day 180

    The perceived barriers to and facilitators of physical activity are measured by EPAP

  3. Pain measurment: numeric scale

    Time frame: day1, day 15, day 180

    The pain is measured by numeric scale

  4. 6 minutes' walk test (6MWT)

    Time frame: day1, day 15, day 180

    Aerobic and functional capacities are measured by 6 minutes' walk test (6MWT)

  5. aerobic capacities

    Time frame: day1, day 15, day 180

    aerobic capacities are measured by sub maximal ergocycle test

  6. muscular endurance

    Time frame: day1, day 15, day 180

    the muscular endurance of the erector muscles of the spine is measured by Sorensen test

  7. muscular endurance of the flexor muscles of the spine

    Time frame: day1, day 15, day 180

    the muscular endurance of the flexor muscles of the spine is measured by ITO test

  8. muscular endurance of the extensor of the knee

    Time frame: day1, day 15, day 180

    the muscular endurance of the extensor of the knee is measured by Killy test

  9. Core measurment

    Time frame: day1, day 15, day 180

    Core is measured by plank test

  10. Flexibility on posterior chain

    Time frame: day1, day 15, day 180

    Flexibility on posterior chain is measured by DDS test

  11. Mobility on posterior chain

    Time frame: day1, day 15, day 180

    Mobility on posterior chain is measured by Schober test

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: E-lombactifs

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 11, 2020
Registry last updated
Feb 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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