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

Not Applicable

Recruiting

• Conditions: Spinal Stenosis

• Registration Number: NCT05312281
• Lead Sponsor: SRH Gesundheitszentrum Bad Herrenalb

Brief 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

Detailed 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.

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-10
• Study First Submitted QC: 2022-03-28
• Last Update Submitted: 2022-03-28
• Study First Posted: 2022-04-05
• Last Update Posted: 2022-04-05
• Study Start: 2022-06-28
• Primary Completion: 2024-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recurrence rate or reherniation/restenosis by means of MRI results	at 104 weeks	symptomatic reduction of Walking distance

Secondary Outcome Measures

Name	Time	Method
Pain and Disability Index	At 0, 2, 6, 12, 24, 52 and 104 weeks	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)

Trial Locations

Locations (1)

Klinikum Karlsruhe; 🇩🇪 Karlsruhe, Germany