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

Chronic Disease Clinical Trial

— ACTIV'DOS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04725344
• Other study ID #: 29BRC20.0294
• Status: Recruiting
• Phase: N/A
• Start date: July 26, 2021
• Est. completion date: July 26, 2024

Study information

• Verified date: June 2024
• Source: University Hospital, Brest
• Contact: Marc Beaumont
• Phone: +33 (0)2 98 62 61 60
• Email: mbeaumont[@]ch-morlaix.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: July 26, 2024
• Est. primary completion date: July 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Disease
• Low Back Pain
• Lumbago

Intervention

Other:
• ACTIV'DOS group
ACTIV'DOS group use ACTIV'DOS application (with smartphone) to do the self rehabilitation each day (15 minutes per day) during 6 weeks. There are 7 exercices.
• Usual practise
Control group uses a standard sheet of paper to do the self-rehabilitation (15 minutes per day) during 6 weeks. There are 7 exercises.

Locations

Country	Name	City	State
France	Cabinet de kinésithérapie Erwan TOLENTIN	Brest
France	Cabinet de kinésithérapie Natanaël AUDREN	Brest
France	Cabinet de kinésithérapie Pierre VAL	Brest
France	Cabinet de kinésithérapie Pol KEROUANTON	Brest
France	Cabinet de kinésithérapie Vincent LUCAS	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from functional impairment with Roland-Morris questionnaire at 6 weeks.	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).	Day 0 (patient inclusion) and Day 42 (end of patient monitoring)
Secondary	Difference of average pain during the seven last days with VAS pain	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.	Day 0 (patient inclusion) and Day 42 (end of patient monitoring)
Secondary	Difference of worse pain during the seven last days with VAS pain	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.	Day 0 (patient inclusion) and Day 42 (end of patient monitoring)
Secondary	Compliance (number of sessions done over the number of recommanded sessions) of self-rehabilitation program at 6 weeks	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).	Day 42 (end of patient monitoring)
Secondary	Assessment of satisfaction with Likert scale	Likert scale is a scale with 10 questions. For each question, the scale ranges from 3 (strongly agree) to -3 (strongly disagree).	Day 42 (end of patient monitoring)