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

SRH Gesundheitszentrum Bad Herrenalb

Status: Enrolling

Conditions: Spinal Stenosis

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

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT05312281

GBH-O1

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)-

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Control group "without lumbar belt"

No Intervention group

Description:

Control group "without lumbar belt"

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

Experimental group

Description:

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

Treatment:

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