Assessment of the Effects of Maela Connected Follow-up on Well-being and Pain After Lumbar Spine Surgery

NCT ID: NCT05680259

Last Updated: 2025-06-10

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-06

Study Completion Date

2026-02-13

Brief Summary

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Digital technologies could reduce the length of hospital stay and improve post-operative recuperation after discharge by offering a remote follow-up. No study has investigated the effects of connected follow-up on lumbar spine inpatients.

The purpose of this project is to assess the effects of connected follow-up on pain and quality of life after lumbar spine surgery.

Detailed Description

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Conditions

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Lumbar Spine Surgery Quality of Life Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Maela connected follow-up

patient will benefit of the Maela connected follow-up

Group Type EXPERIMENTAL

Maela connected follow-up

Intervention Type OTHER

Measures of pain, quality of life and health related variables (coping, self-efficacy, beliefs about pain) will be done at four times before and after surgery.

control group

control group with a traditional follow-up

Group Type ACTIVE_COMPARATOR

traditional follow-up

Intervention Type OTHER

medical recommendations and prescriptions at hospital discharge. Measures of pain, quality of life and health related variables (coping, self-efficacy, beliefs about pain) will be done at four times before and after surgery.

Interventions

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Maela connected follow-up

Measures of pain, quality of life and health related variables (coping, self-efficacy, beliefs about pain) will be done at four times before and after surgery.

Intervention Type OTHER

traditional follow-up

medical recommendations and prescriptions at hospital discharge. Measures of pain, quality of life and health related variables (coping, self-efficacy, beliefs about pain) will be done at four times before and after surgery.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* First ever lumbar spine surgery in the context of a degenerative spinal pathology
* Age between 18 and 60 yo
* Providing free and informed consent to participate
* Having a smartphone able to process MAELA application
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Amiens

Amiens, , France

Site Status

Countries

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France

Other Identifiers

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PI2019_843_0016

Identifier Type: -

Identifier Source: org_study_id

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