Self-rehabilitation At Home After LumbaR Arthrodesis (SAHARA)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Self rehabilitation at home.
- Who it may be relevant to
- Registry conditions: Spondylolisthesis, Lumbar Region. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Self-rehabilitation At Home After LumbaR Arthrodesis
Overview
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.
Interventions
- Other Self rehabilitation at home
6 week program of exercise at home of gradual intensity and duration
Primary outcome measures
- Change of lumbar pain [Time frame: At 6 weeks and 3 months after surgery]
Secondary outcome measures (4)
- Improvement of functional abilities [Time frame: At 6 weeks and 3 months after surgery]
- Improvement of ranges of motion - Ely test [Time frame: At 6 weeks and 3 months after surgery]
- Improvement of ranges of motion - Straight Leg Test [Time frame: At 6 weeks and 3 months after surgery]
- Improvement of ranges of motion - Schober test [Time frame: At 6 weeks and 3 months after surgery]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
France · 1 center
- AP-HP - Hôpital Européen Georges-Pompidou Paris, France — Paris
Identifiers
NCT: NCT06129682 · APHP230526 · 2023-A00652-43