Spinal Stenosis
Conditions
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.
Interventions
DEVICEDevice : Lombastab immo. wear for 6 weeks post-surgery the Lombastab Immo
Wear for 6 weeks post-surgery
Sponsors
SRH Gesundheitszentrum Bad Herrenalb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence rate or reherniation/restenosis by means of MRI results | at 104 weeks | symptomatic reduction of Walking distance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Germany
Contacts
Primary ContactUwe Spetzger, Prof
Backup ContactAndreas Veihelmann, Prof
Outcome results
None listed