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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05312281
Other study ID # GBH-O1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 28, 2022
Est. completion date December 1, 2025

Study information

Verified date March 2022
Source SRH Gesundheitszentrum Bad Herrenalb
Contact Uwe Spetzger, Prof
Phone +497219740
Email uwe.spetzger@klinikum-karlsruhe.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 1, 2025
Est. primary completion date December 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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)-

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Germany Klinikum Karlsruhe Karlsruhe

Sponsors (1)

Lead Sponsor Collaborator
SRH Gesundheitszentrum Bad Herrenalb

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recurrence rate or reherniation/restenosis by means of MRI results symptomatic reduction of Walking distance at 104 weeks
Secondary 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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