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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-28

Study Completion Date

2025-12-01

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

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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.

Conditions

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Spinal Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Control group "without lumbar belt"

Group Type NO_INTERVENTION

No interventions assigned to this group

Device : Lombastab immo. wear for 6 weeks post-surgery the Lombastab Immo

Lombastab immo. wear for 6 weeks post-surgery the Lombastab Immo

Group Type EXPERIMENTAL

Device : Lombastab immo. wear for 6 weeks post-surgery the Lombastab Immo

Intervention Type DEVICE

Wear for 6 weeks post-surgery

Interventions

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Device : Lombastab immo. wear for 6 weeks post-surgery the Lombastab Immo

Wear for 6 weeks post-surgery

Intervention Type DEVICE

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)-

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No