NCT06129682

Brief Summary

Lumbar arthrodesis is more and more common in general population. Patients need early reeducation after surgery but do not always have access to a physiotherapist. The investigators aim to study the benefits of self-rehabilitation at home after lumbar arthrodesis, showing amelioration in lumbar pain and in quality of life for concerned patients. For this, the investigators designed a randomized-controlled study to test if self-rehabilitation at home right after surgery is superior than rehabilitation done by a physiotherapist 4 to 6 weeks after surgery (standard treatment for our patients).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
29mo left

Started Dec 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
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

Study Progress50%
Dec 2023Oct 2028

First Submitted

Initial submission to the registry

November 8, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

December 18, 2023

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

4.8 years

First QC Date

November 8, 2023

Last Update Submit

March 14, 2025

Conditions

Spondylolisthesis, Lumbar Region

Outcome Measures

Primary Outcomes (1)

  • Change of lumbar pain

    Improvement of Short Form 36 score (SF-36) Unit : number of points Each item is graded on a scale of 0 to 100, with 0 and 100 serving as the lowest and highest possible scores. A higher number indicates that the subject is in better overall health.

    At 6 weeks and 3 months after surgery

Secondary Outcomes (4)

  • Improvement of functional abilities

    At 6 weeks and 3 months after surgery

  • Improvement of ranges of motion - Ely test

    At 6 weeks and 3 months after surgery

  • Improvement of ranges of motion - Straight Leg Test

    At 6 weeks and 3 months after surgery

  • Improvement of ranges of motion - Schober test

    At 6 weeks and 3 months after surgery

Study Arms (2)

Standard of care

NO INTERVENTION

Self rehabilitation at home

EXPERIMENTAL
Other: Self rehabilitation at home

Interventions

Self rehabilitation at homeOTHER

6 week program of exercise at home of gradual intensity and duration

Self rehabilitation at home

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Surgery for posterolateral lumbar arthrodesis, from a degenerative etiology, from 1 to 3 lumbar levels (one level means one inter-somatic space)
  • Surgery indication after optimal medical treatment, including appropriate pain medicine, and fail of medical treatment for reducing lumbar pain and/or nerve root pain and/or limp
  • Return home possible after surgery
  • After signing consent during pre-operative visit with the surgeon
  • People under 18 years-old
  • Pregnant or breast-feeding women
  • Psychiatric and/or neurodegenerative comorbidity
  • Motor deficiency of the limbs before and/or after surgery
  • Iliac extension of arthrodesis
  • Any postoperative complication lengthening stay at hospital
  • Medical contraindication for early rehabilitation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AP-HP - Hôpital Européen Georges-Pompidou Paris, France

Paris, Île-de-France Region, 75908, France

RECRUITING

MeSH Terms

Conditions

Spondylolisthesis

Condition Hierarchy (Ancestors)

SpondylolysisSpondylosisSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Marc Khalifé, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Breno MELO, PhD

CONTACT

(0)140271988gestion-locale.drc@aphp.fr

Youcef Sekour

CONTACT

youcef.sekour@aphp.fr

Study Design

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

Study Record Dates

First Submitted

November 8, 2023

First Posted

November 13, 2023

Study Start

December 18, 2023

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2028

Last Updated

March 19, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Two years after the last publication
Access Criteria
Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. The founder could be involved in the decision. Teams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization. Processing of shared data must comply with European General Data Protection Regulation (GDPR).

Locations

FR(1)