Self-rehabilitation At Home After lumbaR Arthrodesis (SAHARA)

Not Applicable

Recruiting

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Self rehabilitation at home	Self rehabilitation at home	-

Primary Outcome Measures

Name	Time	Method
Change of lumbar pain	At 6 weeks and 3 months after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Improvement of ranges of motion - Ely test	At 6 weeks and 3 months after surgery	Improvement of Ely test Angular unit : degree ( ° )
Improvement of ranges of motion - Straight Leg Test	At 6 weeks and 3 months after surgery	Improvement of Straight Leg Test Angular unit : degree ( ° )
Improvement of ranges of motion - Schober test	At 6 weeks and 3 months after surgery	Improvement of Schober test angular unit : degree ( ° )
Improvement of functional abilities	At 6 weeks and 3 months after surgery	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).

Locations (1): AP-HP - Hôpital Européen Georges-Pompidou Paris, France
🇫🇷
Paris, Ile-de-France, France

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