Impact of a Multidisciplinary Rehabilitation Program Associated With the Doado Application in Lowback Pain Management

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-55
SponsorElsan

About this trial

This study is aimed at patients consulting a physiotherapist for acute low-back pain at risk of becoming chronic.

The goal of this study is to compare two types of rehabilitation programs for these patients, on their functional disability at 3 months:

* A multidisciplinary program lasting two weeks, including physiotherapists, rheumatologists, physical medicine and rehabilitation specialists, occupational physicians, psychologists, etc. * A monodisciplinary physiotherapy rehabilitation program consisting of active treatment with a physiotherapist, with 2 to 3 sessions per week for 4 to 5 weeks, based on muscle-strengthening exercises for the trunk and lower limbs and stretching exercises for the back and lower limbs.

Patients will be evaluated before treatment (baseline), and at 1, 3, 6 and 12 months to evaluate the following secondary outcomes: pain, absence of chronicity, evolution of functional disability, muscle endurance, flexibility, level of fear, apprehension and avoidance associated with low back pain over the time, return to work and to physical activities, painful relapses and analgesic treatment consumption.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Suffering from acute common low back pain for less than 3 months at the time of the initial consultation

With a prescription for physiotherapy

Available for both programs

Aged between 20 and 55

Disqualifiers

suffering from a first episode of acute common low back pain for less than one month at the time of the initial consultation

For lumbar arthrodesis in the 12 months prior to inclusion

For lumbar arthroplasty in the 6 months prior to inclusion

For lumbar recalibration or lumbar disc herniation within 3 months of inclusion.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Multidisciplinary management associated with mobile application Doado

    Other intervention

    multidisciplinary program including physiotherapists, rheumatologists, physical medicine and rehabilitation specialists, occupational physicians, psychologists, etc., associated with Doado mobile application

  • Physiotherapy management alone associated with mobile application Doado

    Other intervention

    monodisciplinary physiotherapy rehabilitation program consisting of active treatment with a physiotherapist associated with Doado mobile application

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: Multidisciplinary management associated with mobile application DoadoExperimental treatment 1 intervention
Group B: Physiotherapy management alone associated with mobile application DoadoActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Functional disability

Oswestry disability Index (ODI): 10 questions with 6 possible answers each, to assess the impact of the pain on several life habits and functionalities (walk, personal care, sitting position, etc.). The score is expressed as a percentage of handicap between 0 and 100%.

Time frame
baseline, 3 months

Secondary outcomes

1

Lumbar pain

Mean patient lumbar pain on the last 7 days measured on a visual analog scale. It takes the form of a horizontal line with a qualifier at each end - "no pain (0)" on the left, "maximum imaginable pain (10)" on the right - onto which the patient draws a line (or positions a cursor on the online version), corresponding to the level of intensity of their pain. The result is the distance in mm between 0 and the line.

Time frame
baseline, one month, 3 months, 6 months, 12 months
2

Lumbar pain chronicity

Presence of lumbar pain chronicity, defined by daily continuous pain during at least 12 weeks. This data will be collected from the start and end dates of each recurrence entered by the patient in the patient logbook.

Time frame
over 12 months of follow-up
3

Functional disability

Oswestry disability Index (ODI): 10 questions with 6 possible answers each, to assess the impact of the pain on several life habits and functionalities (walk, personal care, sitting position, etc.). The score is expressed as a percentage of handicap between 0 and 100%.

Time frame
Baseline, one month, 3 months, 6 months, 12 months
4

Muscular endurance (Shirado-Ito test)

The patient must remain as long as possible with the hips and knees bent at 90°, shoulder blades lifted, arms crossed over torso and hands resting on shoulders. The test result is the time, in seconds, that the patient remains in this position (for a maximum of 5 minutes), measured by the physiotherapist using a stopwatch.

Time frame
baseline, one month, 3 months

Other outcomes

Sponsors and contacts

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