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

Not Applicable

Completed

• Conditions: Chronic Low Back Pain

• Registration Number: NCT04264949
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-07
• Study First Submitted QC: 2020-02-10
• Study First Posted: 2020-02-11
• Study Start: 2020-03-09
• Primary Completion: 2023-12-18
• Study Completion: 2023-12-18
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-13
• Last Update Posted: 2024-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
EARS : exercise adherence rating scale	day 180	EARS assess the adherence in physical activity program.

Secondary Outcome Measures

Name	Time	Method
OSWESTRY questionnaire	day1, day 15, day 180	Disability is measured by OSWESTRY
EPAP questionnaire	day1, day 15, day 180	The perceived barriers to and facilitators of physical activity are measured by EPAP
Pain measurment: numeric scale	day1, day 15, day 180	The pain is measured by numeric scale
6 minutes' walk test (6MWT)	day1, day 15, day 180	Aerobic and functional capacities are measured by 6 minutes' walk test (6MWT)
muscular endurance of the extensor of the knee	day1, day 15, day 180	the muscular endurance of the extensor of the knee is measured by Killy test
Core measurment	day1, day 15, day 180	Core is measured by plank test
Mobility on posterior chain	day1, day 15, day 180	Mobility on posterior chain is measured by Schober test
aerobic capacities	day1, day 15, day 180	aerobic capacities are measured by sub maximal ergocycle test
muscular endurance	day1, day 15, day 180	the muscular endurance of the erector muscles of the spine is measured by Sorensen test
Flexibility on posterior chain	day1, day 15, day 180	Flexibility on posterior chain is measured by DDS test
muscular endurance of the flexor muscles of the spine	day1, day 15, day 180	the muscular endurance of the flexor muscles of the spine is measured by ITO test

Trial Locations

Locations (1)

Chu Clermont Ferrand; 🇫🇷 Clermont-Ferrand, France