Self-rehabilitation At Home After lumbaR Arthrodesis (SAHARA)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Self-rehabilitation At Home After lumbaR Arthrodesis

Conditions
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Spondylolisthesis, Lumbar Region

Intervention / Treatment
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* Other: Self rehabilitation at home


Participation Criteria
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Eligibility Criteria
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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 Current anti-thrombotic medication Iliac extension of arthrodesis Any postoperative complication lengthening stay at hospital Medical contraindication for early rehabilitation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of care<br> | |
| Experimental: Self rehabilitation at home<br> | Other: Self rehabilitation at home<br>* 6 week program of exercise at home of gradual intensity and duration<br>|

What is the study measuring?
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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 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 | 
| 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 |