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

NCT ID: NCT05390762

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-03

Study Completion Date

2024-06-20

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.

Detailed Description

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Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

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

Study Groups

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Conventional care in a day hospital

1. A common face to face day hospital, combining physical therapies with psychotherapeutic support such as Cognitive Behavioral Therapy to combat kinesiophobia.
2. A Second phase of 5 weeks of care face to face day hospital of the reconditioning type of 15 sessions.

Group Type ACTIVE_COMPARATOR

Common phase

Intervention Type OTHER

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

Care in Face to Face

Intervention Type OTHER

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

Telecare rehabilitation

1. A common face to face day hospital, combining physical therapies with psychotherapeutic support such as Cognitive Behavioral Therapy to combat kinesiophobia.
2. A Second phase of 5 weeks of Telecare rehabilitation of the reconditioning type of 15 sessions.

Group Type EXPERIMENTAL

Common phase

Intervention Type OTHER

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

Telecare rehabilitation

Intervention Type OTHER

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

Interventions

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Common phase

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

Intervention Type OTHER

Telecare rehabilitation

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

Intervention Type OTHER

Care in Face to Face

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

Intervention Type OTHER

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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pôle Saint Hélier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jephté Houedakor

Role: PRINCIPAL_INVESTIGATOR

Pôle Saint Hélier

Locations

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Pôle Saint-Hélier

Rennes, Brittany Region, France

Site Status

Countries

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France

Other Identifiers

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2022-A00129-34

Identifier Type: -

Identifier Source: org_study_id