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NCT Number: NCT06129682

Self-rehabilitation At Home After LumbaR Arthrodesis (SAHARA)

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).

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Key information

Conditions

Spondylolisthesis, Lumbar Region Bone Diseases Musculoskeletal Diseases Spinal Diseases Spondylolisthesis Spondylolysis Spondylosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AP-HP - Hôpital Européen Georges-Pompidou Paris, France

Paris, Île-de-France Region, 75908, France

Location status: Recruiting

Location contact

Anaïs Venard, MD

CONTACT

Marc Khalifé, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self rehabilitation at home

Other

6 week program of exercise at home of gradual intensity and duration

Primary outcomes

  1. Change of lumbar pain

    Time frame: 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 outcomes

  1. Improvement of functional abilities

    Time frame: 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

    Time frame: At 6 weeks and 3 months after surgery

    Improvement of Ely test Angular unit : degree ( ° )

  3. Improvement of ranges of motion - Straight Leg Test

    Time frame: At 6 weeks and 3 months after surgery

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

  4. Improvement of ranges of motion - Schober test

    Time frame: At 6 weeks and 3 months after surgery

    Improvement of Schober test angular unit : degree ( ° )

Study contacts

Contact information is provided by the study sponsor or research team.

Breno MELO, PhD

CONTACT

[email protected]

(0)140271988 ext. 33

Youcef Sekour

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Self-rehabilitation At Home After LumbaR Arthrodesis

Acronym: SAHARA

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Nov 13, 2023
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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