Lumbar Spine SurgeryHOSPITELNCT05680259
Assessment of the Effects of Maela Connected Follow-up on Well-being and Pain After Lumbar Spine Surgery
A study testing Maela connected follow-up and traditional follow-up in people with Lumbar Spine Surgery and Quality of Life, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lumbar Spine Surgery, Quality of Life, Pain
- What is being tested?
- Maela connected follow-up and traditional follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 6 Oct 2022to 13 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Lumbar Spine Surgery, Quality of Life, Pain
- Being tested
- Maela connected follow-up, traditional follow-up
- Keywords
- mobile app follow-up, lumbar spine surgery, Quality of Life, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Maela connected follow-up | Experimental | patient will benefit of the Maela connected follow-up Receives: Other: Maela connected follow-up |
| control group | Active comparator | control group with a traditional follow-up Receives: Other: traditional follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of number of well-being patients in both groups
Variation of number of well-being patients in both groups
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start6 Oct 2022
- Primary completion13 Feb 2025
- Study completion13 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spine SurgeryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680259
- Sponsor's protocol ID
- PI2019_843_0016
- Acronym
- HOSPITEL
- Status last verified
- Jun 2025
- First submitted
- 6 Oct 2022
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effects of Maela Connected Follow-up on Well-being and Pain After Lumbar Spine Surgery
- ClinicalTrials.gov ID
- NCT05680259
- Acronym / sponsor ID
- HOSPITEL / PI2019_843_0016
- Conditions
- Lumbar Spine Surgery, Quality of Life, Pain
- Keywords
- mobile app follow-up, lumbar spine surgery, Quality of Life, Pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 6 Oct 2022 (actual)
- Primary completion
- 13 Feb 2025 (actual)
- Study completion
- 13 Feb 2026 (estimated)
- First posted
- 11 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maela connected follow-up | Experimental | Other: Maela connected follow-uppatient will benefit of the Maela connected follow-up |
| control group | Active comparator | Other: traditional follow-upcontrol group with a traditional follow-up |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maela connected follow-upMeasures 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. | Other | Maela connected follow-up |
| traditional follow-upmedical 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. | Other | control group |
Primary outcome
Variation of number of well-being patients in both groups
Time frame: two months
Variation of number of well-being patients in both groups
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maela connected follow-up and traditional follow-up in people with Lumbar Spine Surgery and Quality of Life, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of number of well-being patients in both groups (time frame: two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.