NCT05680259

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

October 6, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 11, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2026

Completed
Last Updated

June 10, 2025

Status Verified

June 1, 2025

Enrollment Period

2.4 years

First QC Date

October 6, 2022

Last Update Submit

June 5, 2025

Conditions

Lumbar Spine SurgeryQuality of LifePain

Keywords

mobile app follow-uplumbar spine surgeryQuality of LifePain

Outcome Measures

Primary Outcomes (1)

  • Variation of number of well-being patients in both groups

    Variation of number of well-being patients in both groups

    two months

Study Arms (2)

Maela connected follow-up

EXPERIMENTAL

patient will benefit of the Maela connected follow-up

Other: Maela connected follow-up

control group

ACTIVE COMPARATOR

control group with a traditional follow-up

Other: traditional follow-up

Interventions

Maela connected follow-upOTHER

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.

Maela connected follow-up
traditional follow-upOTHER

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.

control group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80054, France

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2022

First Posted

January 11, 2023

Study Start

October 6, 2022

Primary Completion

February 13, 2025

Study Completion

February 13, 2026

Last Updated

June 10, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)