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NCT05680259 Clinical Trial

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

Pain Clinical Trial

— HOSPITEL  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05680259
Other study ID # PI2019_843_0016
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 6, 2022
Est. completion date December 2023

Study information
Verified date October 2022
Source Centre Hospitalier Universitaire, Amiens
Contact Christine Desenclos, MD
Phone 03 22 08 89 54
Email desenclos.christine@chu-amiens.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date December 2023
Est. primary completion date October 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• 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.
• 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.

Locations
Country Name City State
France CHU Amiens Amiens

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Variation of number of well-being patients in both groups Variation of number of well-being patients in both groups two months
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