Telecare Rehabilitation Program in Chronic Low Back Pain With Psychological Retention and Predominant Sociability

Study Overview
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Brief Summary
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The present study proposes to evaluate the impact of a multidisciplinary biopsychosocial Telecare rehabilitation program at the functional level in people with chronic low back pain with major psycho-behavior maintenance. The hypothesis is that a personalized program combining remote psycho-professional and physical care by digital tools improves functional evaluation in these patients.

Official Title
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Evaluation of the Functional Efficacy of a Multidisciplinary Telecare Rehabilitation Program in Chronic Low Back Pain With Psychological Retention and Predominant Sociability : Single Center Randomized Controlled, Single-blind Trial

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: Common phase
* Other: Telecare rehabilitation
* Other: Care in Face to Face


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic low back pain (evolution of more than 3 months) Patient treated for this pathology in a multidisciplinary program Dallas score > 50% in anxiety/depression and sociability dimensions Patient who has given free and informed consent to participate in the research Patient affiliated to a social security scheme or beneficiary of such a scheme. Patient with an internet connection at home, allowing videoconferencing and a digital tool with web cam (tablet or computer). Exclusion Criteria: Recent spine surgery (< 3 months at inclusion visit) Cardiovascular risk factor contraindicating sports practice. Severe psychiatric pathology Low back pain of tumoral or inflammatory origin. Associated motor or sensory, neurological impairment. Disabling root irradiation Pregnant or breastfeeding women Patients under legal protection (guardianship, curators or safeguard of justice).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional care in a day hospital<br>A common face to face day hospital, combining physical therapies with psychotherapeutic support such as Cognitive Behavioral Therapy to combat kinesiophobia. A Second phase of 5 weeks of care face to face day hospital of the reconditioning type of 15 sessions. | Other: Common phase<br>* A common face to face day hospital combining physical therapies with psychotherapeutic support such as Cognitive Behavioral Therapy to combat kinesiophobia.<br>Other: Care in Face to Face<br>* A Second phase of 5 weeks of care in face to face day hospital of the reconditioning type of 15 sessions.<br>|
| Experimental: Telecare rehabilitation<br>A common face to face day hospital, combining physical therapies with psychotherapeutic support such as Cognitive Behavioral Therapy to combat kinesiophobia. A Second phase of 5 weeks of Telecare rehabilitation of the reconditioning type of 15 sessions. | Other: Common phase<br>* A common face to face day hospital combining physical therapies with psychotherapeutic support such as Cognitive Behavioral Therapy to combat kinesiophobia.<br>Other: Telecare rehabilitation<br>* A Second phase of 5 weeks of telecare rehabilitation of the reconditioning type of 15 sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index | Overall score of the Oswestry self-questionnaire. The score goes from 0 to 50, It will be converted into a percentage (Score ODI). Zero is equated with no disability and 100 is the maximum disability possible. | 3 months after the end of rehabilitation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Economic efficiency | The economic efficiency of personalized rehabilitation at the end of the rehabilitation measured by the cost of transport evaluated according to the functional evolution by Oswestry. | At the end of the rehabilitation | 
| Spontaneous pain | The spontaneous pain measured by Visual Analogic Scale, from 0 to 100. The 0 represents no pain at all and 100 the worth pain imaginable. | At the end of the rehabilitation and 3 month after. | 
| Overall flexibility | Measured finger ground distance in centimeters. The patient is asked to touch the ground with both hands while standing with the knees in extension. The distance between the fingertip and the ground is recorded. Higher the distance is, the better it is. | At the end of the rehabilitation and 3 month after. | 
| Range of motion of lumbar mobility | Active range of motion of lumbar flexion and lumbar extension will be measured with two inclinometers. Higher the score is, the better it is. | At the end of the rehabilitation and 3 month after. | 
| Sub pelvis muscle flexibility. | The sub pelvis muscle flexibility will be measured by goniometry and centimetry. Higher the score is, the better it is. | At the end of the rehabilitation and 3 month after. | 
| Quadriceps strength | Testing will be done 90 degrees of knee flexion using a wall. The maximum holding time will be determined with a chronometer (in seconds). Higher the score is, the better it is. | At the end of the rehabilitation and 3 month after. | 
| Endurance of trunk extensors | Measured by the Sorensen-Biering Test (duration in seconds), higher the score is, the better it is. | At the end of the rehabilitation and 3 month after. | 
| Endurance of trunk flexors | Measured by the Shirado test (duration in seconds), higher the score is, the better it is. | At the end of the rehabilitation and 3 month after. | 
| Anxiety and depression | The Anxiety and depression are assessed by the self administered Hospital Anxiety and Depression scale (HAD). It has 14 items from 0 to 3. 7 questions concern, depression and 7 anxiety. The total for each scale is 21. If the score is less than 7, there in no symptomatology. | At the end of the rehabilitation and 3 month after. | 
| The kinesiophobia | Assessment of the kinesiophobia index by the TAMPA questionnaire. There are 17 questions, from 1 to 4. If the score is high (more than 40 on 68), the kinesiophobia is significant. | At the end of the rehabilitation and 3 month after. | 
| Functional abilities | Evaluation of the functional disability with the dallas pain questionnaire. It's divided in 4 parts : impact on daily activities, impact on the relation between professional activities and leisure, impact on the relation between anxiety and depression and the impact on sociability. The Dallas questionnaire evaluated the impact of pain from 0 (no impact) to 100% (maximum impact). | At the end of the rehabilitation and 3 month after. | 
| Socio professional criteria | The rate of patients having resumed a professional activity and condition of resumption (part-time therapeutic or not, previous position or adapted position). | 3 months after the end of rehabilitation | 
| Compliance | Self-assessment compliance evaluated by an adherence booklet | At the end of the rehabilitation | 
| Acceptability | The acceptability will be assessed using a 18-item questionnaire based on the Unified Theory of Acceptance and Use of Technology (UTAUT) model. Each questions are based on a Likert-type 5 point scale ranging from : 1=In total disagreement, 2= Somewhat disagree, 3= Neither agree nor disagree, 4= Somewhat agree, 5=In total agreement. | At the end of the rehabilitation program and 3 months after. |