Lumbar Spinal StenosisCLEMOBNCT02610335
Evaluation of Spinal Mobility Reeducation in Patients Treated for a Lumbar Spinal Stenosis After Epidural Infiltration
A study testing Test group in people with Lumbar Spinal Stenosis, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
In actual practice the patients with mild or moderate lumbar spinal stenosis symptoms receive an epidural infiltration and participate in kyphosis reeducation in first intention. Yet the kyphosis reeducation did not show a real profit in the time compared with the natural evolution of the pathology. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- Test group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2016to 1 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 50 years,
- central, acquired and multi-staged lumbar spinal stenosis,
- pain since at least three months,
- radicular pains higher than the lumbar pains,
- walking distance < 1000 m,
- oral consent.
Who cannot join
- intercurrent pathology limiting the walking distance (arteriopathy, cardio-respiratory insufficiency, disabling arthrosis affecting the lower limbs...),
- history of spinal surgery for lumbar spinal stenosis,
- extended lumbar arthrodesis (equal to or greater than 2 levels),
- monosegmental and degenerative spondylolisthesis,
- foraminal stenosis,
- motor deficit of the lower limbs or Cauda equina syndrome ("Cauda equina" syndrome (CES) is a serious neurologic condition in which damage to the cauda equina causes acute loss of function of the lumbar plexus, (nerve roots) of the spinal canal below the termination (conus medullaris) of the spinal cord),
- bleeding disorders or allergies contraindicating the epidural infiltration.
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital of Bordeaux - Hospital Pellegrin
Bordeaux, 33000
About this study
Official title: Evaluation of Spinal Mobility Reeducation in Patients Treated for a Lumbar Spinal Stenosis After Epidural Infiltration. Randomized and Comparative Study: Kyphosis Reeducation Versus Spinal Mobility Reeducation
In actual practice the patients with mild or moderate lumbar spinal stenosis symptoms receive an epidural infiltration and participate in kyphosis reeducation in first intention. Yet the kyphosis reeducation did not show a real profit in the time compared with the natural evolution of the pathology. The study assume that the spinal mobility reeducation will reduce the incidence of pain recurrences compared with the classic kyphosis reeducation.
Read the detailed description
The standard treatment of lumbar spinal stenosis is the lumbar canal recalibration surgery which presents co-morbidity factors and risks of post-operative complications. The non-invasive methods are a good alternative compared with the surgery : the patients medically treated present few damages and the results of the postponed surgery are equivalent to the immediate surgery. That is why a non-surgical treatment is proposed in first intention to the patients with mild or moderate symptoms : this treatment associates an epidural infiltration and a kyphosis reeducation.
Yet the kyphosis reeducation did not show a real profit in the time compared with the natural evolution of the pathology. The benefits of the infiltration are lost three months after this one in 80 % of the cases. A return to physical activity and a restored spinal mobility would improve the duration of the infiltration effect. The objective is then to compare the efficiency of a spinal mobility reeducation program versus a kyphosis reeducation program in patients with acquired and central lumbar spinal stenosis. It is a prospective, monocentric, randomized, superiority and parallel-group study :
- group C (control group) : kyphosis reeducation + patient education + auto-reeducation at home,
- group M (test group) : spinal mobility reeducation + patient education + auto-reeducation at home.
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- Control group (C), Test group
- Keywords
- lumbar spinal stenosis
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control group (C)Other
- kyphosis reeducation on Huber platform during 2 weeks,
- patient education : on physiopathology of the lumbar spinal stenosis and treatments as well as healthy lifestyle and prevention (plans of anatomy, plastic column, slides of medical imaging),
- flexibility exercises, stretching exercises and abdominal muscles exercises : to continue at home (the exercises will be reported on a book that will be given to the patient),
- exercises on cycle ergometer or walking on treadmill : to continue at home.
Test groupOther
- spinal mobility reeducation on Huber platform during 2 weeks,
- patient education : on physiopathology of the lumbar spinal stenosis and treatments as well as healthy lifestyle and prevention (plans of anatomy, plastic column, slides of medical imaging),
- flexibility exercises and mobilization exercises : to continue at home (the exercises will be reported on a book that will be given to the patient),
- exercises on cycle ergometer or walking on treadmill : to continue at home.
| Study group | Role | What they receive |
|---|---|---|
| Control group (C) | Active comparator | Kyphosis reeducation + patient education + auto-reeducation at home Receives: Other: Control group (C) |
| Test group (M) | Other | Spinal mobility reeducation + patient education + auto-reeducation at home. Receives: Other: Test group |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximal walking distance
: ratio between the maximal walking distance at the 90 days visit and the maximal walking distance at the Day 4 in percent. Walking on a plane road, 70 m in length, without obstacle and with markings every 10 meters (total length : not more than 2 km).
Measured: the 90 days visit
Secondary outcomes (35)
evaluation of the lumbar pain
evaluation of the lumbar pain: measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),
Measured: Day 0
evaluation of the lumbar pain
evaluation of the lumbar pain: measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),
Measured: Day 4
evaluation of the lumbar pain
evaluation of the lumbar pain: measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),
Measured: Day 30
evaluation of the lumbar pain
evaluation of the lumbar pain: measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),
Measured: Day 90
evaluation of the lumbar pain
evaluation of the lumbar pain: measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),
Measured: Day 365
evaluation of the radicular pain
measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),
Measured: Day 0
evaluation of the radicular pain
measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),
Measured: Day 4
evaluation of the radicular pain
measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),
Measured: Day 30
evaluation of the radicular pain
measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),
Measured: Day 90
evaluation of the radicular pain
measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),
Measured: Day 365
evaluation scales
evaluation scales : score of Quebec (functional impotence)
Measured: Day 0
evaluation scales
evaluation scales : score of Quebec (functional impotence)
Measured: Day 4
evaluation scales
evaluation scales : score of Quebec (functional impotence)
Measured: Day 30
evaluation scales
evaluation scales : score of Quebec (functional impotence)
Measured: Day 90
evaluation scales
evaluation scales : score of Quebec (functional impotence)
Measured: Day 365
maximal walking distance
maximal walking distance : on a defined road
Measured: Day 0
maximal walking distance
maximal walking distance : on a defined road
Measured: Day 4
maximal walking distance
maximal walking distance : on a defined road
Measured: Day 30
maximal walking distance
maximal walking distance : on a defined road
Measured: Day 90
maximal walking distance
maximal walking distance : on a defined road
Measured: Day 365
compliance with the auto-reeducation at home
compliance with the auto-reeducation at home : questionnaire.
Measured: Day 30
compliance with the auto-reeducation at home
compliance with the auto-reeducation at home : questionnaire.
Measured: Day 90
compliance with the auto-reeducation at home
compliance with the auto-reeducation at home : questionnaire.
Measured: Day 365
Score of Japanese Orthopaedic Association (llumbar radiculopathy)
Measured: Day 4
Score of Japanese Orthopaedic Association (llumbar radiculopathy)
Measured: Day 30
Score of Japanese Orthopaedic Association (llumbar radiculopathy)
Measured: Day 90
Score of Japanese Orthopaedic Association (llumbar radiculopathy)
Measured: Day 365
score of "Douleur Neuropathique 4" (DN4 - neuropathy)
Measured: Day 4
score of "Douleur Neuropathique 4" (DN4 - neuropathy)
Measured: Day 30
score of "Douleur Neuropathique 4" (DN4 - neuropathy)
Measured: Day 90
score of "Douleur Neuropathique 4" (DN4 - neuropathy)
Measured: Day 365
score Medical Outcomes Study Short-Form General Health Survey 12 (health status)
Measured: Day 4
score Medical Outcomes Study Short-Form General Health Survey 12 (health status)
Measured: Day 30
score Medical Outcomes Study Short-Form General Health Survey 12 (health status)
Measured: Day 90
score Medical Outcomes Study Short-Form General Health Survey 12 (health status)
Measured: Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study start15 Jan 2016
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Why it stopped: The recruitment of participants was very difficult despite a change in the organisation. The inclusion criteria did not result in the expected number of participants, and the credits ran out.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathieu DE-SÈZE, MD, Study director, service de médecine physique et de réadaptation, Centre Hospitalier Universitaire de Bordeaux,Antoine BENARD, MD, Study chair, USMR CHU Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02610335
- Sponsor's protocol ID
- CHUBX 2012/36
- Acronym
- CLEMOB
- Status last verified
- Oct 2020
- First submitted
- 4 Jun 2015
- Last updated
- 26 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Berney J. [Epidemiology of narrow spinal canal]. Neurochirurgie. 1994;40(3):174-8. French.
PubMed 7723924Weinstein JN, Lurie JD, Tosteson TD, Hanscom B, Tosteson AN, Blood EA, Birkmeyer NJ, Hilibrand AS, Herkowitz H, Cammisa FP, Albert TJ, Emery SE, Lenke LG, Abdu WA, Longley M, Errico TJ, Hu SS. Surgical versus nonsurgical treatment for lumbar degenerative spondylolisthesis. N Engl J Med. 2007 May 31;356(22):2257-70. doi: 10.1056/NEJMoa070302.
PubMed 17538085Yamashita K, Ohzono K, Hiroshima K. Five-year outcomes of surgical treatment for degenerative lumbar spinal stenosis: a prospective observational study of symptom severity at standard intervals after surgery. Spine (Phila Pa 1976). 2006 Jun 1;31(13):1484-90. doi: 10.1097/01.brs.0000219940.26390.26.
PubMed 16741459Rillardon L, Guigui P, Veil-Picard A, Slulittel H, Deburge A. [Long-term results of surgical treatment of lumbar spinal stenosis]. Rev Chir Orthop Reparatrice Appar Mot. 2003 Nov;89(7):621-31. French.
PubMed 14699308Lieberman I. Surgery reduced pain and disability in lumbar spinal stenosis better than nonoperative treatment. J Bone Joint Surg Am. 2007 Aug;89(8):1872. doi: 10.2106/JBJS.8908.ebo2. No abstract available.
PubMed 17671033
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Spinal Mobility Reeducation in Patients Treated for a Lumbar Spinal Stenosis After Epidural Infiltration. Randomized and Comparative Study: Kyphosis Reeducation Versus Spinal Mobility Reeducation
- ClinicalTrials.gov ID
- NCT02610335
- Acronym / sponsor ID
- CLEMOB / CHUBX 2012/36
- Conditions
- Lumbar Spinal Stenosis
- Keywords
- lumbar spinal stenosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The recruitment of participants was very difficult despite a change in the organisation. The inclusion criteria did not result in the expected number of participants, and the credits ran out.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 15 Jan 2016 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 20 Nov 2015 (estimated)
- 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.
In actual practice the patients with mild or moderate lumbar spinal stenosis symptoms receive an epidural infiltration and participate in kyphosis reeducation in first intention. Yet the kyphosis reeducation did not show a real profit in the time compared with the natural evolution of the pathology. The study assume that the spinal mobility reeducation will reduce the incidence of pain recurrences compared with the classic kyphosis reeducation.
Detailed description
The standard treatment of lumbar spinal stenosis is the lumbar canal recalibration surgery which presents co-morbidity factors and risks of post-operative complications. The non-invasive methods are a good alternative compared with the surgery : the patients medically treated present few damages and the results of the postponed surgery are equivalent to the immediate surgery. That is why a non-surgical treatment is proposed in first intention to the patients with mild or moderate symptoms : this treatment associates an epidural infiltration and a kyphosis reeducation.
Yet the kyphosis reeducation did not show a real profit in the time compared with the natural evolution of the pathology. The benefits of the infiltration are lost three months after this one in 80 % of the cases. A return to physical activity and a restored spinal mobility would improve the duration of the infiltration effect. The objective is then to compare the efficiency of a spinal mobility reeducation program versus a kyphosis reeducation program in patients with acquired and central lumbar spinal stenosis. It is a prospective, monocentric, randomized, superiority and parallel-group study :
- group C (control group) : kyphosis reeducation + patient education + auto-reeducation at home,
- group M (test group) : spinal mobility reeducation + patient education + auto-reeducation at home.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group (C) | Active comparator | Other: Control group (C)Kyphosis reeducation + patient education + auto-reeducation at home |
| Test group (M) | Other | Other: Test groupSpinal mobility reeducation + patient education + auto-reeducation at home. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age > 50 years,
- central, acquired and multi-staged lumbar spinal stenosis,
- pain since at least three months,
- radicular pains higher than the lumbar pains,
- walking distance < 1000 m,
Key exclusion criteria (7 listed)
- intercurrent pathology limiting the walking distance (arteriopathy, cardio-respiratory insufficiency, disabling arthrosis affecting the lower limbs...),
- history of spinal surgery for lumbar spinal stenosis,
- extended lumbar arthrodesis (equal to or greater than 2 levels),
- monosegmental and degenerative spondylolisthesis,
- foraminal stenosis,
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 |
|---|---|---|
| Control group (C)* kyphosis reeducation on Huber platform during 2 weeks, * patient education : on physiopathology of the lumbar spinal stenosis and treatments as well as healthy lifestyle and prevention (plans of anatomy, plastic column, slides of medical imaging), * flexibility exercises, stretching exercises and abdominal muscles exercises : to continue at home (the exercises will be reported on a book that will be given to the patient), * exercises on cycle ergometer or walking on treadmill : to continue at home. | Other | Control group (C) |
| Test group* spinal mobility reeducation on Huber platform during 2 weeks, * patient education : on physiopathology of the lumbar spinal stenosis and treatments as well as healthy lifestyle and prevention (plans of anatomy, plastic column, slides of medical imaging), * flexibility exercises and mobilization exercises : to continue at home (the exercises will be reported on a book that will be given to the patient), * exercises on cycle ergometer or walking on treadmill : to continue at home. | Other | Test group (M) |
Primary outcome
maximal walking distance
Time frame: the 90 days visit
: ratio between the maximal walking distance at the 90 days visit and the maximal walking distance at the Day 4 in percent. Walking on a plane road, 70 m in length, without obstacle and with markings every 10 meters (total length : not more than 2 km).
35 secondary outcomes
evaluation of the lumbar pain
Time frame: Day 0
evaluation of the lumbar pain
Time frame: Day 4
evaluation of the lumbar pain
Time frame: Day 30
evaluation of the lumbar pain
Time frame: Day 90
evaluation of the lumbar pain
Time frame: Day 365
evaluation of the radicular pain
Time frame: Day 0
evaluation of the radicular pain
Time frame: Day 4
evaluation of the radicular pain
Time frame: Day 30
evaluation of the radicular pain
Time frame: Day 90
evaluation of the radicular pain
Time frame: Day 365
evaluation scales
Time frame: Day 0
evaluation scales
Time frame: Day 4
evaluation scales
Time frame: Day 30
evaluation scales
Time frame: Day 90
evaluation scales
Time frame: Day 365
maximal walking distance
Time frame: Day 0
maximal walking distance
Time frame: Day 4
maximal walking distance
Time frame: Day 30
maximal walking distance
Time frame: Day 90
maximal walking distance
Time frame: Day 365
compliance with the auto-reeducation at home
Time frame: Day 30
compliance with the auto-reeducation at home
Time frame: Day 90
compliance with the auto-reeducation at home
Time frame: Day 365
Score of Japanese Orthopaedic Association (llumbar radiculopathy)
Time frame: Day 4
Score of Japanese Orthopaedic Association (llumbar radiculopathy)
Time frame: Day 30
Score of Japanese Orthopaedic Association (llumbar radiculopathy)
Time frame: Day 90
Score of Japanese Orthopaedic Association (llumbar radiculopathy)
Time frame: Day 365
score of "Douleur Neuropathique 4" (DN4 - neuropathy)
Time frame: Day 4
score of "Douleur Neuropathique 4" (DN4 - neuropathy)
Time frame: Day 30
score of "Douleur Neuropathique 4" (DN4 - neuropathy)
Time frame: Day 90
score of "Douleur Neuropathique 4" (DN4 - neuropathy)
Time frame: Day 365
score Medical Outcomes Study Short-Form General Health Survey 12 (health status)
Time frame: Day 4
score Medical Outcomes Study Short-Form General Health Survey 12 (health status)
Time frame: Day 30
score Medical Outcomes Study Short-Form General Health Survey 12 (health status)
Time frame: Day 90
score Medical Outcomes Study Short-Form General Health Survey 12 (health status)
Time frame: Day 365
Results and safety
The study was stopped early (reason given: The recruitment of participants was very difficult despite a change in the organisation. The inclusion criteria did not result in the expected number of participants, and the credits ran out.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
- Background: PubMed 7723924Berney J. [Epidemiology of narrow spinal canal]. Neurochirurgie. 1994;40(3):174-8. French.
- Background: PubMed 17538085Weinstein JN, Lurie JD, Tosteson TD, Hanscom B, Tosteson AN, Blood EA, Birkmeyer NJ, Hilibrand AS, Herkowitz H, Cammisa FP, Albert TJ, Emery SE, Lenke LG, Abdu WA, Longley M, Errico TJ, Hu SS. Surgical versus nonsurgical treatment for lumbar degenerative spondylolisthesis. N Engl J Med. 2007 May 31;356(22):2257-70. doi: 10.1056/NEJMoa070302.
- Background: PubMed 16741459Yamashita K, Ohzono K, Hiroshima K. Five-year outcomes of surgical treatment for degenerative lumbar spinal stenosis: a prospective observational study of symptom severity at standard intervals after surgery. Spine (Phila Pa 1976). 2006 Jun 1;31(13):1484-90. doi: 10.1097/01.brs.0000219940.26390.26.
- Background: PubMed 14699308Rillardon L, Guigui P, Veil-Picard A, Slulittel H, Deburge A. [Long-term results of surgical treatment of lumbar spinal stenosis]. Rev Chir Orthop Reparatrice Appar Mot. 2003 Nov;89(7):621-31. French.
- Background: PubMed 17671033Lieberman I. Surgery reduced pain and disability in lumbar spinal stenosis better than nonoperative treatment. J Bone Joint Surg Am. 2007 Aug;89(8):1872. doi: 10.2106/JBJS.8908.ebo2. No abstract available.
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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. This study is not recruiting at the moment.
Mathieu DE-SÈZE, MD study director
service de médecine physique et de réadaptation, Centre Hospitalier Universitaire de Bordeaux,
Antoine BENARD, MD study chair
USMR CHU Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test group in people with Lumbar Spinal Stenosis, run by University Hospital, Bordeaux 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 6 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: stopped early, as of the sponsor's last update on 26 Oct 2020. 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?
The study was stopped early (reason given: The recruitment of participants was very difficult despite a change in the organisation. The inclusion criteria did not result in the expected number of participants, and the credits ran out.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximal walking distance (time frame: the 90 days visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02610335, which also lists 5 linked publications.
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 26 Oct 2020.