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The aim of the study is to assess the benefit of wearing a lumbar orthosis after surgery for spinal stenosis. It will be evaluated if a post-surgery immobilization for 6 weeks with a lumbar orthosis reduces early recurrence, increases walking distance, decreases significantly faster pain and pain medication after surgery
Spinal stenosis and orthoses The study situation in this regard is very poor, high-quality level 1 studies are not available.
A study by Prateepavanich et al. from 2001 shows advantages in the therapy with lumbar orthoses in neurogenic spinal claudication in the context of conservative therapy (9). Regarding postoperative prescription, expert opinions have long diverged (10). Nevertheless, in a survey of North American spine surgeons, over 60% reported prescribing an orthosis postoperatively (11).
2 Aim of the study
The aim of this study is to show that patients after surgical decompression for lumbar spinal stenosis and patients after surgical sequestrectomy benefit from temporary postoperative immobilization using a lumbar orthosis.
To show that postoperative therapy with a lumbar orthosis prolongs walking distance and reduces early recurrence.
It will be shown that postoperative pain decreases significantly faster and thus pain medication can be reduced faster early postoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group "without lumbar belt" | No Intervention | Control group "without lumbar belt" | |
| Device : Lombastab immo. wear for 6 weeks post-surgery the Lombastab Immo | Experimental | Lombastab immo. wear for 6 weeks post-surgery the Lombastab Immo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device : Lombastab immo. wear for 6 weeks post-surgery the Lombastab Immo | Device | Wear for 6 weeks post-surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence rate or reherniation/restenosis by means of MRI results | symptomatic reduction of Walking distance | at 104 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pain and Disability Index | Visual analog scale (VAS) (visual analog scale of 0-10, 0 means no pain, 10 means extreme pain, we expect better outcome with Lombastab), Oswestry Disability Questionaire (german version scale of 0-50, 0 means no impairment at all, 50 means highest possible impairment, we expect lower impairment due to Lombastab) | At 0, 2, 6, 12, 24, 52 and 104 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Uwe Spetzger, Prof | Contact | +497219740 | uwe.spetzger@klinikum-karlsruhe.de | |
| Andreas Veihelmann, Prof | Contact | +497083926 | 4023 | andreas.veihelmann@sportklinik-stuttgart.de |
| Name | Affiliation | Role |
|---|---|---|
| Andreas Veihelmann, Prof | SRH Ges.-Zentrum Bad Herrenalb | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Karlsruhe | Recruiting | Karlsruhe | 76133 | Germany |
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| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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