Relevance of the Activ'Dos App for Chronic Low Back Pain Patients

Not Applicable

Terminated

• Conditions: Chronic Disease; Lumbago
• Interventions: Other: ACTIV'DOS group; Other: Usual practise

• Registration Number: NCT04725344
• Lead Sponsor: University Hospital, Brest

Brief Summary

The purpose of this study is to compare a self rehabilitation program using ACTIV'DOS app versus using a standard sheet of paper.

Detailed Description

This study involves patients with chronic low back pain. The purpose of this study is to compare a self-rehabilitation program using ACTIV'DOS app versus a standard sheet of paper. Disabilities are measured with a Roland-Morris questionnaire.

Study Timeline

• Study First Submitted: 2021-01-04
• Study First Submitted QC: 2021-01-25
• Study First Posted: 2021-01-26
• Study Start: 2021-07-26
• Primary Completion: 2023-05-09
• Study Completion: 2023-05-09
• Status Verified: 2024-07
• Last Update Submitted: 2024-08-02
• Last Update Posted: 2024-08-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• chronic low back pain for more than 3 months
• Aged to 18 or more
• Possibility to use Activ'dos application with smartphone or tablet
• Initial score of Roland Morris questionnaire >= 4
• Fit to consent
• Who has signed consent form

Exclusion Criteria

• Any signs of severe illness underlying to radicular and lumbar pain like red flags
• Guardianship or protection of vulnerable adult
• Pregnant or nursing
• Refuse to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACTIV'DOS group	ACTIV'DOS group	ACTIV'DOS is a smartphone application of self rehabilitation. There are 7 muscular exercices. Patients going to exercices during 15 minutes per day, during 6 weeks.
Control group	Usual practise	This group uses a sheet of paper for self-rehabilitation exercise. The self-rehabilitation program is the same as the ACTIV'DOS group. Patients have to exercise during 15 minutes per day, during 6 weeks.

Primary Outcome Measures

Name	Time	Method
Change from functional impairment with Roland-Morris questionnaire at 6 weeks.	Day 0 (patient inclusion) and Day 42 (end of patient monitoring)	Disabilities are measured with Roland-Morris questionnaire, from Day 0 to Day 42. This questionnaire includes 24 items with 1 point per item. The score ranges from 0 (no disability) to 24 (max. disability).

Secondary Outcome Measures

Name	Time	Method
Assessment of satisfaction with Likert scale	Day 42 (end of patient monitoring)	Likert scale is a scale with 10 questions. For each question, the scale ranges from 3 (strongly agree) to -3 (strongly disagree).
Difference of worse pain during the seven last days with VAS pain	Day 0 (patient inclusion) and Day 42 (end of patient monitoring)	VAS pain is a scale measuring pain intensity from 0 (no pain) to 10 (extreme pain). For this outcome, the worse pain during the seven last days is evaluated.
Difference of average pain during the seven last days with VAS pain	Day 0 (patient inclusion) and Day 42 (end of patient monitoring)	VAS pain is a scale measuring pain intensity from 0 (no pain) to 10 (extreme pain). For this outcome, the average pain during the seven last days is evaluated.
Compliance (number of sessions done over the number of recommanded sessions) of self-rehabilitation program at 6 weeks	Day 42 (end of patient monitoring)	Compliance is evaluated with a compliance table. Patients have to complete this table after each session. Investigators will report the compliance table at the end of the patient monitoring (Week 6).

Trial Locations

Locations (4)

Cabinet de kinésithérapie Natanaël AUDREN; 🇫🇷 Brest, France

Cabinet de kinésithérapie Pierre VAL; 🇫🇷 Brest, France

Cabinet de kinésithérapie Vincent LUCAS; 🇫🇷 Brest, France

Cabinet de kinésithérapie Pol KEROUANTON; 🇫🇷 Brest, France