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

  • STATUS
    Recruiting
  • End date
    Dec 1, 2025
  • participants needed
    100
  • sponsor
    SRH Gesundheitszentrum Bad Herrenalb
Updated on 18 April 2022

Summary

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

Description

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.

Details
Condition Spinal Stenosis
Treatment Device : Lombastab immo. wear for 6 weeks post-surgery the Lombastab Immo
Clinical Study IdentifierNCT05312281
SponsorSRH Gesundheitszentrum Bad Herrenalb
Last Modified on18 April 2022

Eligibility

Yes No Not Sure

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)-
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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