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

NCT04725344 | Terminated

• 1 other identifier: 29BRC20.0294
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 4

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.

Conditions

Chronic Disease; Lumbago

Keywords

Exercise; Self-rehabilitation; Chronic low back pain; Mobile app; mHealth; eHealth; Physiotherapy; Disability; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Difference of average pain during the seven last days with VAS pain

  Day 0 (patient inclusion) and Day 42 (end of patient monitoring)

• Difference of worse pain during the seven last days with VAS pain

  Day 0 (patient inclusion) and Day 42 (end of patient monitoring)

• Compliance (number of sessions done over the number of recommanded sessions) of self-rehabilitation program at 6 weeks

  Day 42 (end of patient monitoring)

• Assessment of satisfaction with Likert scale

  Day 42 (end of patient monitoring)

Study Arms (2)

ACTIV'DOS group

EXPERIMENTAL

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.

Other: ACTIV'DOS group

Control group

EXPERIMENTAL

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.

Other: Usual practise

Interventions

ACTIV'DOS group OTHER

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.

ACTIV'DOS group

Usual practise OTHER

Control group uses a standard sheet of paper to do the self-rehabilitation (15 minutes per day) during 6 weeks. There are 7 exercises.

Control group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (4)

Cabinet de kinésithérapie Natanaël AUDREN

Brest, 29200, France

Location

Cabinet de kinésithérapie Pierre VAL

Brest, 29200, France

Location

Cabinet de kinésithérapie Pol KEROUANTON

Brest, 29200, France

Location

Cabinet de kinésithérapie Vincent LUCAS

Brest, 29200, France

Location

MeSH Terms

Conditions

Chronic Disease; Low Back Pain; Motor Activity; Pain

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Back Pain; Neurologic Manifestations; Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There are 2 groups : an interventional group with ACTIV'DOS app ; and a control group with a standard procedure using a sheet of paper.

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 26, 2021
• Study Start: July 26, 2021
• Primary Completion: May 9, 2023
• Study Completion: May 9, 2023
• Last Updated: August 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest University Hospital. Requestors will be required to sign and complete a data access agreement.

Locations

FR (4)