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

E-lombaqual: 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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Low-back Pain

• Study Type: Observational
• Enrollment (Estimated): 25

Contacts and Locations

• Study Contact: Name: Lise laclautre; Phone Number: 04 73 75 11 95; Email: promo_interne_drci@chu-clermontferrand.fr

Study Locations

• France
  • Clermont-Ferrand, France
    • Recruiting
    • Chu Clermont-Ferrand
    • Principal Investigator: Jean-Baptiste LECHAUVE
    • Contact: Lise Laclautre; Phone Number: 0473751195; Email: promo_interne_drci@chu-clermontferrand.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients will be contacted in the Physical Medicine and Rehabilitation department of Clermont-Ferrand University Hospital for a presentation of the study. They will be given an information leaflet and time to reflect on their participation. If the patient agrees to take part, the EAPA will schedule an appointment to complete the non-objection form. A semi-structured interview will be scheduled in an office on the PRM ward, in order to meet the study objectives. Again, the objectives of the study will be stated, as well as the instructions for this structured interview.

Questionnaires will be submitted and completed only after the interview. Data will be collected on a dictaphone and then manually transcribed into text format (verbatims) during the interview by a second operator.

An a posteriori analysis will be carried out using the qualitative method. The interview guide is likely to be adapted according to the first individual interviews, as required by the qualitative method.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phenomenological analysis of semi-structured interviews with patients.	45-minute semi-structured interview	Up to 1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of patient expectations via a semi-structured interview	45-minute semi-structured interview	Up to 1 day
Characterization of patients' profiles using a socio-demographic	Responses to the socio-demographic questionnaire : sex in ration Male and femalle	Up to 1 day
Characterization of patients' profiles using a socio-demographic	Responses to the socio-demographic questionnaire : age in year	Up to 1 day
Characterization of patients' profiles using a socio-demographic	Responses to the socio-demographic questionnaire : height in cm	Up to 1 day
Characterization of patients' profiles using a socio-demographic	Responses to the socio-demographic questionnaire : family situation as a couple or single	Up to 1 day
Characterization of patients' profiles using a socio-demographic	Responses to the socio-demographic questionnaire : weight in Kg	Up to 1 day
Characterization of patients' profiles using a socio-demographic	Responses to the socio-demographic questionnaire : level of education (no diploma, less than baccalaureate, baccalaureate or more than baccalaureate)	Up to 1 day
Characterization of patients' profiles using a socio-demographic	Responses to the socio-demographic questionnaire : lifestyle (active, retired, disabled)	Up to 1 day
Characterization of patients' profiles using a socio-demographic	Responses to the socio-demographic questionnaire : living environment (urban, rural)	Up to 1 day
Characterization of patients' profiles using a socio-demographic	Responses to the socio-demographic questionnaire : leisure activities (frequency, type)	Up to 1 day
Functional disability	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.	Up to 1 day
Characterization of patients' profiles using a socio-demographic	Responses to the socio-demographic questionnaire : regular physical activity (frequency, type of activity)	Up to 1 day
Physical Activity Perception Scale	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".	Up to 1 day
Visual Analogue Pain Scale	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.	Up to 1 day
Fears and beliefs	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.	Up to 1 day

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2024
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: July 12, 2024
• First Submitted That Met QC Criteria: July 18, 2024
• First Posted (Actual): July 24, 2024

Study Record Updates

• Last Update Posted (Actual): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 19, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: chronic low back pain; smartphone; qualitative study; m-health
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: RNI 2024 LECHAUVE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No