Clinical trial NCT06517342: Motivations, Obstacles and Opportunities for Using a Health Application to Encourage Physical Activity in People With Chronic Low Back Pain
Official title: E-lombaqual: Motivations, Obstacles and Opportunities for Using a Health Application to Encourage Physical Activity in People With Chronic Low Back Pain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Low-back Pain
Keywords: chronic low back pain
m-health
smartphone
qualitative study
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Phenomenological analysis of semi-structured interviews with patients.
timeFrame: Up to 1 day
Secondary outcomes:
measure: Identification of patient expectations via a semi-structured interview
timeFrame: Up to 1 day
measure: Characterization of patients' profiles using a socio-demographic
timeFrame: Up to 1 day
measure: Characterization of patients' profiles using a socio-demographic
timeFrame: Up to 1 day
measure: Characterization of patients' profiles using a socio-demographic
timeFrame: Up to 1 day
measure: Characterization of patients' profiles using a socio-demographic
timeFrame: Up to 1 day
measure: Characterization of patients' profiles using a socio-demographic
timeFrame: Up to 1 day
measure: Characterization of patients' profiles using a socio-demographic
timeFrame: Up to 1 day
measure: Characterization of patients' profiles using a socio-demographic
timeFrame: Up to 1 day
measure: Characterization of patients' profiles using a socio-demographic
timeFrame: Up to 1 day
measure: Characterization of patients' profiles using a socio-demographic
timeFrame: Up to 1 day
measure: Characterization of patients' profiles using a socio-demographic
timeFrame: Up to 1 day
measure: Physical Activity Perception Scale
timeFrame: Up to 1 day
measure: Visual Analogue Pain Scale
timeFrame: Up to 1 day
measure: Functional disability
timeFrame: Up to 1 day
measure: Fears and beliefs
timeFrame: Up to 1 day
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
References: