Self-rehabilitation At Home After LumbaR Arthrodesis (SAHARA)
ConditionSpondylolisthesis, Lumbar Region
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Self rehabilitation at home
Other intervention6 week program of exercise at home of gradual intensity and duration
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Standard of careNo intervention 0 interventions
Group B: Self rehabilitation at homeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
At 6 weeks and 3 months after surgerySecondary outcomes
1
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).
Time frame
At 6 weeks and 3 months after surgery2
Improvement of ranges of motion - Ely test
Improvement of Ely test Angular unit : degree ( ° )
Time frame
At 6 weeks and 3 months after surgery3
Improvement of ranges of motion - Straight Leg Test
Improvement of Straight Leg Test Angular unit : degree ( ° )
Time frame
At 6 weeks and 3 months after surgery4
Improvement of ranges of motion - Schober test
Improvement of Schober test angular unit : degree ( ° )
Time frame
At 6 weeks and 3 months after surgerySponsors and contacts
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Source ClinicalTrials.gov