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Self-rehabilitation At Home After lumbaR Arthrodesis (SAHARA)

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06129682
Collaborator
(none)
120
Enrollment
1
Location
2
Arms
17
Anticipated Duration (Months)
7.1
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Self rehabilitation at home
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Self-rehabilitation At Home After lumbaR Arthrodesis
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2025
Anticipated Study Completion Date :
Apr 1, 2025

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Standard of care
Experimental: Self rehabilitation at home

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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).

  2. Improvement of ranges of motion - Ely test [At 6 weeks and 3 months after surgery]

    Improvement of Ely test Angular unit : degree ( ° )

  3. Improvement of ranges of motion - Straight Leg Test [At 6 weeks and 3 months after surgery]

    Improvement of Straight Leg Test Angular unit : degree ( ° )

  4. Improvement of ranges of motion - Schober test [At 6 weeks and 3 months after surgery]

    Improvement of Schober test angular unit : degree ( ° )

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 AP-HP - Hôpital Européen Georges-Pompidou Paris, France Paris Ile-de-France France 75908

Sponsors and Collaborators

  • Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Marc Khalifé, MD, Assistance Publique - Hôpitaux de Paris

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT06129682
Other Study ID Numbers:
  • APHP230526
  • 2023-A00652-43
First Posted:
Nov 13, 2023
Last Update Posted:
Nov 18, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Spondylolisthesis

Study Results

No Results Posted as of Nov 18, 2023