Self-rehabilitation At Home After LumbaR Arthrodesis (SAHARA)

Assistance Publique - Hôpitaux de Paris

Status

Enrolling

Conditions

Spondylolisthesis, Lumbar Region

Treatments

Other: Self rehabilitation at home

Study type

Interventional

Funder types

Other

Identifiers

NCT06129682

APHP230526

2023-A00652-43 (Other Identifier)

Details and patient eligibility

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).

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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