Telecare Rehabilitation Program in Chronic Low Back Pain With Psychological Retention and Predominant Sociability - Clinical Trial for Low Back Pain | NCT05390762

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Common phase

Telecare rehabilitation

Care in Face to Face

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Pôle Saint-HélierRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional care in a day hospital

Telecare rehabilitation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

Sub pelvis muscle flexibility.

The sub pelvis muscle flexibility will be measured by goniometry and centimetry. Higher the score is, the better it is.

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.

Endurance of trunk extensors

Measured by the Sorensen-Biering Test (duration in seconds), higher the score is, the better it is.

Endurance of trunk flexors

Measured by the Shirado test (duration in seconds), higher the score is, the better it is.

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.

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.

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).

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).

Compliance

Self-assessment compliance evaluated by an adherence booklet

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.

Full Information

NCT ID

NCT05390762

First Posted

May 6, 2022

Last Updated

May 19, 2022

Sponsor

Pôle Saint Hélier

1. Study Identification

Unique Protocol Identification Number

NCT05390762

Brief Title

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

Acronym

TELELOMB

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 3, 2022 (Actual)

Primary Completion Date

April 2024 (Anticipated)

Study Completion Date

April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pôle Saint Hélier

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Masking Description

The evaluations will be performed by blind operators of the program.

Allocation

Randomized

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Conventional care in a day hospital

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Telecare rehabilitation

Arm Type

Experimental

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Common phase

Intervention Description

A common face to face day hospital combining physical therapies with psychotherapeutic support such as Cognitive Behavioral Therapy to combat kinesiophobia.

Intervention Type

Other

Intervention Name(s)

Telecare rehabilitation

Intervention Description

A Second phase of 5 weeks of telecare rehabilitation of the reconditioning type of 15 sessions.

Intervention Type

Other

Intervention Name(s)

Care in Face to Face

Intervention Description

A Second phase of 5 weeks of care in face to face day hospital of the reconditioning type of 15 sessions.

Primary Outcome Measure Information:

Title

Oswestry Disability Index

Description

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.

Time Frame

3 months after the end of rehabilitation

Secondary Outcome Measure Information:

Title

Economic efficiency

Description

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.

Time Frame

At the end of the rehabilitation

Title

Spontaneous pain

Description

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.

Time Frame