Spondylolisthesis, Lumbar RegionSAHARANCT06129682
Self-rehabilitation At Home After LumbaR Arthrodesis (SAHARA)
A study testing Self rehabilitation at home in people with Spondylolisthesis, Lumbar Region, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondylolisthesis, Lumbar Region
- What is being tested?
- Self rehabilitation at home
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 18 Dec 2023to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Youcef Sekour contact
France1 site, 1 recruiting
- Recruiting
AP-HP - Hôpital Européen Georges-Pompidou Paris, France
Paris, Île-de-France Region, 75908
Marc Khalifé, MD, marc.khalife@aphp.fr
Anaïs Venard, MD
About this study
Official title: Self-rehabilitation At Home After LumbaR Arthrodesis
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).
Read the 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.
- Conditions
- Spondylolisthesis, Lumbar Region
- Being tested
- Self rehabilitation at home
- Medical subject headings
- Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self rehabilitation at homeOther
6 week program of exercise at home of gradual intensity and duration
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | Not described |
| Self rehabilitation at home | Experimental | Not described Receives: Other: Self rehabilitation at home |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 6 weeks and 3 months after surgery
Secondary outcomes (4)
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).
Measured: At 6 weeks and 3 months after surgery
Improvement of ranges of motion - Ely test
Improvement of Ely test Angular unit : degree ( ° )
Measured: At 6 weeks and 3 months after surgery
Improvement of ranges of motion - Straight Leg Test
Improvement of Straight Leg Test Angular unit : degree ( ° )
Measured: At 6 weeks and 3 months after surgery
Improvement of ranges of motion - Schober test
Improvement of Schober test angular unit : degree ( ° )
Measured: At 6 weeks and 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start18 Dec 2023
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spondylolisthesis, Lumbar RegionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Khalifé, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06129682
- Sponsor's protocol ID
- APHP230526
- Other IDs
- 2023-A00652-43
- Acronym
- SAHARA
- Status last verified
- Mar 2025
- First submitted
- 8 Nov 2023
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-rehabilitation At Home After LumbaR Arthrodesis
- ClinicalTrials.gov ID
- NCT06129682
- Acronym / sponsor ID
- SAHARA / APHP230526
- Conditions
- Spondylolisthesis, Lumbar Region
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | – |
| Self rehabilitation at home | Experimental | Other: Self rehabilitation at home |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self rehabilitation at home6 week program of exercise at home of gradual intensity and duration | Other | Self rehabilitation at home |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Related trials for Spondylolisthesis, Lumbar Region
Not yet recruiting
Prospective Study of ProteiOS in Lumbar Interbody Fusion (TLIF)
Degenerative Disc Disease, Spinal Stenosis Lumbar
RecruitingObservational study
Adult Patient Outcomes After Spine Surgery With Fibergraft BG Putty/Viper Prime
Spondylolisthesis, Lumbar Region, Spinal Trauma With Neurological Deficit
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Youcef Sekour contact
Marc Khalifé, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self rehabilitation at home in people with Spondylolisthesis, Lumbar Region, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Breno MELO, PhD ((0)140271988 ext. 33, gestion-locale.drc@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of lumbar pain (time frame: At 6 weeks and 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.