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

Chronic Low Back Pain Clinical Trial

— E-lombactifs  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04264949
• Other study ID #: RBHP 2019 LECHAUVE
• Secondary ID: 2019-A02191-56
• Status: Completed
• Phase: N/A
• Start date: March 9, 2020
• Est. completion date: December 18, 2023

Study information

• Verified date: February 2024
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 18, 2023
• Est. primary completion date: December 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Other:
• Education in the use of smartphone app (Mon coach dos)
In addition to conventional care and the therapeutic education program, GA will benefit from three education sessions (one per week) on the use of the smartphone app mon coach dos
• conventional care
conventional care and the therapeutic education program

Locations

Country	Name	City	State
France	Chu Clermont Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EARS : exercise adherence rating scale	EARS assess the adherence in physical activity program.	day1
Primary	EARS : exercise adherence rating scale	EARS assess the adherence in physical activity program.	day 15
Primary	EARS : exercise adherence rating scale	EARS assess the adherence in physical activity program.	day 180
Secondary	OSWESTRY questionnaire	Disability is measured by OSWESTRY	day1, day 15, day 180
Secondary	EPAP questionnaire	The perceived barriers to and facilitators of physical activity are measured by EPAP	day1, day 15, day 180
Secondary	Pain measurment: numeric scale	The pain is measured by numeric scale	day1, day 15, day 180
Secondary	6 minutes' walk test (6MWT)	Aerobic and functional capacities are measured by 6 minutes' walk test (6MWT)	day1, day 15, day 180
Secondary	aerobic capacities	aerobic capacities are measured by sub maximal ergocycle test	day1, day 15, day 180
Secondary	muscular endurance	the muscular endurance of the erector muscles of the spine is measured by Sorensen test	day1, day 15, day 180
Secondary	muscular endurance of the flexor muscles of the spine	the muscular endurance of the flexor muscles of the spine is measured by ITO test	day1, day 15, day 180
Secondary	muscular endurance of the extensor of the knee	the muscular endurance of the extensor of the knee is measured by Killy test	day1, day 15, day 180
Secondary	Core measurment	Core is measured by plank test	day1, day 15, day 180
Secondary	Flexibility on posterior chain	Flexibility on posterior chain is measured by DDS test	day1, day 15, day 180
Secondary	Mobility on posterior chain	Mobility on posterior chain is measured by Schober test	day1, day 15, day 180