Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06129682

Self-rehabilitation At Home After LumbaR Arthrodesis (SAHARA)

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-03-19

120

Participants Needed

1

Research Sites

249 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Self-rehabilitation At Home After LumbaR Arthrodesis (SAHARA)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Lumbar pain and/or nerve root pain and/or limp without any motor deficiency of the limbs before or after surgery
  • Scheduled for posterolateral lumbar arthrodesis surgery for degenerative causes involving 1 to 3 lumbar levels
  • Surgery indicated after failure of optimal medical treatment including appropriate pain medication
  • Able to return home after surgery
  • Signed informed consent during pre-operative visit with the surgeon
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Pregnant or breastfeeding women
  • Psychiatric or neurodegenerative comorbidities
  • Motor deficiency of the limbs before or after surgery
  • Iliac extension of arthrodesis
  • Any postoperative complication causing extended hospital stay
  • Medical contraindication for early rehabilitation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

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

Actively Recruiting

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Research Team

B

Breno MELO, PhD

CONTACT

Y

Youcef Sekour

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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