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Symptomatic lumbar spinal stenosis is the most common indication for spinal surgery. However, more than one-third of the patients undergoing surgery for lumbar stenosis report dissatisfaction with the results. On the other hand, conservative treatment has shown positive results in some cases. This trial will compare the outcomes of surgical versus non-surgical treatment for lumbar stenosis.
This is a three-centre randomised controlled trial in which 200 patients with symptomatic lumbar spinal stenosis will be randomised into one of two treatment arms. The patients in the surgical arm will undergo decompression of the neural structures by use of any open or minimally invasive (MIS) technique with or without fusion; the patients in the non-surgical arm will undergo imaging assisted percutaneous interspinous spacer insertion with fusion.
The primary outcome of the study will be the Oswestry Disability Index. Secondary outcomes will include motor amplitude and degree of denervation activity obtained by means of nerve conduction studies and electromyography.
Patient-reported outcome measures will be also used as secondary outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| surgery | Active Comparator | Oper or minimally invasive surgery |
|
| percutaneous | Active Comparator | percutaneous non-surgical insertion of interspinous device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimally invasive surgery | Procedure | Surgery with decompression. Central decompression of the stenotic segment with undercutting of the lateral recesses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| oswestry disability Index | system based on a % scale, with higher scores indicating greater disability; clinically important difference to improvement: 10% | 26 weeks |
| oswestry disability Index | system based on a % scale, with higher scores indicating greater disability; clinically important difference to improvement: 10% | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Euro Quality of life Five-Dimensional descriptive system questionnaire (EQ-5D) | 26 and 52 weeks | |
| Numeric Rating Scale (NRS) | for low back and leg pain (0-10 being 10 worst) | 26 and 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alessandro napoli, md, phd | Contact | +390649974521 | alessandro.napoli@uniroma1.it | |
| silvia ciotti | Contact | +390649974521 | silvia.ciotti@uniroma1.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sapienza University of Rome, Policlinico Umberto I Hospital | Recruiting | Rome | Italy |
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investigator-initiated, prospective, phase III, randomized, controlled clinical trial At the 6-month follow-up, there is a possibility of cross- over from group B to group A. After crossover to surgery, the after-treatment of these patients will be as in group A.
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| Percutaneous Spacer | Procedure | percutaneous image guided outpatient procedure that enables interspinous spacer insertion and fusion |
|
| subjective walking ability tool | 26 and 52 weeks |
| neurophysiological measurements (NCSs/EMG) | 52 weeks |
| ID | Term |
|---|---|
| D013168 | Spondylolisthesis |
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D013169 | Spondylolysis |
| D055009 | Spondylosis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D019060 | Minimally Invasive Surgical Procedures |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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