Study Comparing Postoperative Treatment After Surgical Decompression for Lumbar Spinal Stenosis.

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Prospective Randomised Study Comparing Postoperative Treatment After Surgical Decompression for Lumbar Spinal Stenosis. With and Without Immobilisation in an Orthosis

Conditions
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Spinal Stenosis

Intervention / Treatment
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* Device: Device : Lombastab immo. wear for 6 weeks post-surgery the Lombastab Immo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Decompression with hemi-/ partial laminectomy, one. Laminectomy, and foraminotomy. Flavectomy with undercutting due to uni-and multi-segmental spinal stenosis. Age 20-80 years Pre-operative walking distance at least 100m Consent form signed by the patient Exclusion Criteria: Fusion surgery or recurrent surgery Tumors of the spine Cervical spinal stenosis or myelopathy Rheumatoid arthritis or similar autoimmune disease Infection - request for a pension Dyspnea due to heart failure with limited walking distance Peripheral Arterial Occlusive Disease (PAOD)-

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group without lumbar belt<br>Control group without lumbar belt | |
| Experimental: Device : Lombastab immo. wear for 6 weeks post-surgery the Lombastab Immo<br>Lombastab immo. wear for 6 weeks post-surgery the Lombastab Immo | Device: Device : Lombastab immo. wear for 6 weeks post-surgery the Lombastab Immo<br>* Wear for 6 weeks post-surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate or reherniation/restenosis by means of MRI results | symptomatic reduction of Walking distance | at 104 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 |