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NCT Number: NCT06517342

Motivations, Obstacles and Opportunities for Using a Health Application to Encourage Physical Activity in People With Chronic Low Back Pain

In industrialized countries, low back pain can be considered a priority health issue. Some studies define it as one of the leading causes of disability in people under 45, or the leading cause of musculoskeletal disorders, with a prevalence of 26.9%. Chronic forms account for less than 10% of acute episodes, but represent around 85% of costs. It has been recognized that rest and physical inactivity are not beneficial in the treatment of low back pain, and worse, increase the risk of chronicity. Functional Restoration of the Spine (FRS) programs have been introduced in rehabilitation centers, and have proved to be effective both physically and psycho-socially. Patients generally adhere well to this type of program during in-center treatment. The effects obtained tend to fade rapidly on discharge, due to a lack of adherence to what can be offered conventionally (exercise sheets, oral advice). The development of connected tools (smartphones, tablets, etc.) could be a lever in this respect, as it would enable better patient support. In 2022, 84% of the population will own a smartphone. The content offered would be of higher quality, and would enable regular remote monitoring of the patient. The effects of the initial intensive treatment would be maintained by this new interactive, fun tool.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location status: Recruiting

Location contact

Jean-Baptiste LECHAUVE

PRINCIPAL_INVESTIGATOR

Lise Laclautre

CONTACT

[email protected]

0473751195

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Major patients
  • Chronic non-specific low-back pain.
  • Diagnosis confirmed according to HAS definition (i.e. pain located between the thoraco-lumbar hinge and the lower gluteal fold. It may be associated with radiculalgia corresponding to pain in one or both lower limbs at the level of one or more dermatomes). Patients included in the study must have given written informed consent.

Exclusion criteria

  • Patients not meeting HAS diagnostic criteria
  • Patients with comprehension difficulties (making it impossible to fill in questionnaires)
  • Patients with medical contraindications to physical exercise
  • Patients under guardianship, curatorship or safeguard of justice.
  • Patients without a smartphone

Treatment and study plan

Primary outcomes

  1. Phenomenological analysis of semi-structured interviews with patients.

    Time frame: Up to 1 day

    45-minute semi-structured interview

Secondary outcomes

  1. Identification of patient expectations via a semi-structured interview

    Time frame: Up to 1 day

    45-minute semi-structured interview

  2. Characterization of patients' profiles using a socio-demographic

    Time frame: Up to 1 day

    Responses to the socio-demographic questionnaire : sex in ration Male and femalle

  3. Characterization of patients' profiles using a socio-demographic

    Time frame: Up to 1 day

    Responses to the socio-demographic questionnaire : age in year

  4. Characterization of patients' profiles using a socio-demographic

    Time frame: Up to 1 day

    Responses to the socio-demographic questionnaire : height in cm

  5. Characterization of patients' profiles using a socio-demographic

    Time frame: Up to 1 day

    Responses to the socio-demographic questionnaire : family situation as a couple or single

  6. Characterization of patients' profiles using a socio-demographic

    Time frame: Up to 1 day

    Responses to the socio-demographic questionnaire : weight in Kg

  7. Characterization of patients' profiles using a socio-demographic

    Time frame: Up to 1 day

    Responses to the socio-demographic questionnaire : level of education (no diploma, less than baccalaureate, baccalaureate or more than baccalaureate)

  8. Characterization of patients' profiles using a socio-demographic

    Time frame: Up to 1 day

    Responses to the socio-demographic questionnaire : lifestyle (active, retired, disabled)

  9. Characterization of patients' profiles using a socio-demographic

    Time frame: Up to 1 day

    Responses to the socio-demographic questionnaire : living environment (urban, rural)

  10. Characterization of patients' profiles using a socio-demographic

    Time frame: Up to 1 day

    Responses to the socio-demographic questionnaire : regular physical activity (frequency, type of activity)

  11. Characterization of patients' profiles using a socio-demographic

    Time frame: Up to 1 day

    Responses to the socio-demographic questionnaire : leisure activities (frequency, type)

  12. Physical Activity Perception Scale

    Time frame: Up to 1 day

    Self-questionnaire score: Physical Activity Perception Scale (EPAP). Identification of barriers and levers to regular physical activity using the EPAP questionnaire. This questionnaire contains 26 items on the facilities and obstacles encountered when engaging in physical activity. The maximum score for this questionnaire is 100 points thanks to an equation. Responses range from "Strongly disagree" (0 points) to "Strongly agree" (4 points). The total score ranges from 0 - "Poor perception of physical activity" to 100 - "Excellent perception of physical activity".

  13. Visual Analogue Pain Scale

    Time frame: Up to 1 day

    Visual Analogue Pain Scale (VAS Pain). A value of 10 indicates very intense pain. On the contrary, a pain value of 0 means that no pain is felt.

  14. Functional disability

    Time frame: Up to 1 day

    Self-questionnaire score: OSWESTRY Disabitity Index (ODI). Questionnaire on disability rated by a Likert scale ranging from 0 "no restriction" to 5 "severe restriction". scores can range from 0 to 50 points. a score of 0 to 4 indicates no disability. A score of 5 to 14 indicates a mild disability, 15 to 24 a moderate disability, and 25 to 34 a severe disability. A higher score indicates complete disability.

  15. Fears and beliefs

    Time frame: Up to 1 day

    Self-questionnaire score : Fear Avoidance Belief Questionnaire (FABQ). The FABQ consists of 2 subscales, corresponding to two distinct subsections. The first subscale (items 1-5) is the physical activity subscale (FABQPA; PA - Physical activity), and the second subscale (items 6-16) is the work subscale (FABQW; W-Work). Each subscale is ranked separately by summing the item responses of the respective scale (0-6 for each item). For scoring purposes, only 4 of the physical items on the activity scale are rated (24 possible points) and only 7 of the work items (42 possible points). A higher score indicates higher levels of fear-avoidance beliefs.

Study contacts

Contact information is provided by the study sponsor or research team.

Lise Laclautre

CONTACT

[email protected]

04 73 75 11 95

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

E-lombaqual: Motivations, Obstacles and Opportunities for Using a Health Application to Encourage Physical Activity in People With Chronic Low Back Pain

Acronym: E-lombaqual

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 24, 2024
Registry last updated
Sep 22, 2025

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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