Self-rehabilitation At Home After lumbaR Arthrodesis (SAHARA) (SAHARA)

Self-rehabilitation At Home After lumbaR Arthrodesis

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).

Study Overview

• Status: Recruiting
• Conditions: Spondylolisthesis, Lumbar Region
• Intervention / Treatment: Other: Self rehabilitation at home

Detailed Description

Due to population aging, lumbar arthrodesis is becoming more frequent in general population. At the same time, those patients need early rehabilitation, even if they do not experiment any motor disability after surgery : it has been showed that early rehabilitation improves lumbar pain thanks to muscle strengthening.

The design of the study is prospective,monocentric, controlled and randomized. This study compares progressive self-rehabilitation at home after lumbar arthrodesis, explained to the patient by a physiotherapist during his or her stay at the hospital and started right after surgery, versus rehabilitation done by a physiotherapist 4 to 6 weeks after surgery (standard treatment).

The primary outcome is decrease of lumbar pain at 6 weeks and 3 months after surgery. The secondary outcomes are improvement of functional abilities and improvement of pelvis and limbs ranges of motion.

Patients of both groups will be followed by surgeon and physiotherapist at 6 weeks and 3 months.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Breno MELO, PhD; Phone Number: 33 (0)140271988; Email: gestion-locale.drc@aphp.fr
• Study Contact Backup: Name: Youcef Sekour; Email: youcef.sekour@aphp.fr

Study Locations

• France
  • Ile-de-France
    • Paris, Ile-de-France, France, 75908
      • Recruiting
      • AP-HP - Hôpital Européen Georges-Pompidou Paris, France
      • Contact: Marc Khalifé, MD; Email: marc.khalife@aphp.fr
      • Contact: Anaïs Venard, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Lumbar pain and/or nerve root pain and/or limp without any motor deficiency of the limbs, before and/or after surgery (if any motor deficiency occurs after surgery, it will be a secondary exclusion criteria)
• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of care
Experimental: Self rehabilitation at home	Other: Self rehabilitation at home; 6 week program of exercise at home of gradual intensity and duration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of ranges of motion - Ely test	Improvement of Ely test Angular unit : degree ( ° )	At 6 weeks and 3 months after surgery
Improvement of ranges of motion - Straight Leg Test	Improvement of Straight Leg Test Angular unit : degree ( ° )	At 6 weeks and 3 months after surgery
Improvement of ranges of motion - Schober test	Improvement of Schober test angular unit : degree ( ° )	At 6 weeks and 3 months after surgery
Improvement of functional abilities	Improvement of Oswestry Disability Index (ODI) Unit : number of points The ODI consists of 10 patient-completed questions in which the response options are presented as 6-point Likert scales. Scores range from 0% (no disability) to 100% (most severe disability).	At 6 weeks and 3 months after surgery

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Marc Khalifé, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2023
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: November 8, 2023
• First Submitted That Met QC Criteria: November 8, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Spondylolisthesis
• Other Study ID Numbers: APHP230526; 2023-A00652-43 (Other Identifier: Agence nationale de sécurité du médicament et des produits de santé)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
• IPD Sharing Time Frame: Two years after the last publication

IPD Sharing 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).

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No