Clinical trial NCT04264949: E-lombactifs: Evaluation of the Impact a Smartphone Application on Adherence an Exercise Program in Chronic Low Back Pain
Official title: E-lombactifs: Evaluation of the Impact a Smartphone Application on Adherence an Exercise Program in Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: Chronic Low Back Pain
Physical activity
Adherence
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: EARS : exercise adherence rating scale
timeFrame: day1
measure: EARS : exercise adherence rating scale
timeFrame: day 15
measure: EARS : exercise adherence rating scale
timeFrame: day 180
Secondary outcomes:
measure: OSWESTRY questionnaire
timeFrame: day1, day 15, day 180
measure: EPAP questionnaire
timeFrame: day1, day 15, day 180
measure: Pain measurment: numeric scale
timeFrame: day1, day 15, day 180
measure: 6 minutes' walk test (6MWT)
timeFrame: day1, day 15, day 180
measure: aerobic capacities
timeFrame: day1, day 15, day 180
measure: muscular endurance
timeFrame: day1, day 15, day 180
measure: muscular endurance of the flexor muscles of the spine
timeFrame: day1, day 15, day 180
measure: muscular endurance of the extensor of the knee
timeFrame: day1, day 15, day 180
measure: Core measurment
timeFrame: day1, day 15, day 180
measure: Flexibility on posterior chain
timeFrame: day1, day 15, day 180
measure: Mobility on posterior chain
timeFrame: day1, day 15, day 180
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Chu Clermont Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Jean-Baptiste Lechauve
role: PRINCIPAL_INVESTIGATOR
References: