Self-rehabilitation At Home After lumbaR Arthrodesis (SAHARA)

Spondylolisthesis, Lumbar Region Clinical Trial

— SAHARA  

Official title:

Self-rehabilitation At Home After lumbaR Arthrodesis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06129682
• Other study ID #: APHP230526
• Secondary ID: 2023-A00652-43
• Status: Recruiting
• Phase: N/A
• Start date: December 18, 2023
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Breno MELO, PhD
• Phone: (0)140271988
• Email: gestion-locale.drc[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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:

• 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

Related Conditions & MeSH terms

• Spondylolisthesis
• Spondylolisthesis, Lumbar Region

Intervention

Other:
• Self rehabilitation at home
6 week program of exercise at home of gradual intensity and duration

Locations

Country	Name	City	State
France	AP-HP - Hôpital Européen Georges-Pompidou Paris, France	Paris	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Improvement of ranges of motion - Ely test	Improvement of Ely test Angular unit : degree ( ° )	At 6 weeks and 3 months after surgery
Secondary	Improvement of ranges of motion - Straight Leg Test	Improvement of Straight Leg Test Angular unit : degree ( ° )	At 6 weeks and 3 months after surgery
Secondary	Improvement of ranges of motion - Schober test	Improvement of Schober test angular unit : degree ( ° )	At 6 weeks and 3 months after surgery