Clinical trial NCT06129682: Self-rehabilitation At Home After LumbaR Arthrodesis (SAHARA)
Official title: Self-rehabilitation At Home After LumbaR Arthrodesis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spondylolisthesis, Lumbar Region
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of lumbar pain
timeFrame: At 6 weeks and 3 months after surgery
Secondary outcomes:
measure: Improvement of functional abilities
timeFrame: At 6 weeks and 3 months after surgery
measure: Improvement of ranges of motion - Ely test
timeFrame: At 6 weeks and 3 months after surgery
measure: Improvement of ranges of motion - Straight Leg Test
timeFrame: At 6 weeks and 3 months after surgery
measure: Improvement of ranges of motion - Schober test
timeFrame: At 6 weeks and 3 months after surgery
Other outcomes:
Locations:
city: Paris
country: France
facility: AP-HP - Hôpital Européen Georges-Pompidou Paris, France
state: Ile-de-France
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Marc Khalifé, MD
role: PRINCIPAL_INVESTIGATOR
References: