Actively Recruiting
Activity Levels Amongst Patients with Lumbar Spinal Stenosis
Led by Region Zealand · Updated on 2024-11-14
80
Participants Needed
2
Research Sites
236 weeks
Total Duration
On this page
Sponsors
R
Region Zealand
Lead Sponsor
R
Region Syddanmark
Collaborating Sponsor
AI-Summary
What this Trial Is About
Lumbar spinal stenosis (LSS) is one of the most common degenerative diseases of the spinal column, with symptoms including low back pain which worsens with ambulation, poor balance, decreased activity due to pain, and a marked decrease in quality of life (QoL). Prevalence rises with age, and current treatment options range from varied conservative management strategies, to surgical intervention with decompression of neural structures. While the effects of surgical decompression on back pain and QoL has been widely researched, the effects of surgery on activity levels is less well understood. Though patients generally have subjective improvements in this parameter after surgery, objective measurements in this patient group have been lacking. This study aims to investigate the effects of decompressive surgery on activity levels in elderly patients with LSS. Measurements of activity will be taken before and after decompressive surgery, as well as with regular intervals during a two-year follow-up period. A better understanding of the effect that LSS has on activity may lead to more patients being able to receive surgical treatment, which is hypothesized to lead to an increase in QoL and less perceived disability amongst this patient group.
CONDITIONS
Official Title
Activity Levels Amongst Patients with Lumbar Spinal Stenosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 years or older
- Referred for decompressive spinal surgery due to symptomatic lumbar spinal stenosis at one or more levels
- Central canal lumbar spinal stenosis grade B or C by Magnetic Resonance Imaging at one or more levels
- At least 3 months of unsuccessful non-operative treatment
You will not qualify if you...
- Signs of malignancy or infection in the spinal column
- Severe comorbidities including neurodegenerative conditions affecting balance
- Previous decompressive surgery at the same vertebral level (revision surgery)
- Spinal surgery within 1 year prior to inclusion
- Mini Mental State Exam (MMSE) score of 27 points or less
- Degenerative spondylolisthesis greater than 3mm on pre-operative imaging
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Ortopædkirurgisk afdeling, Sjællands Universitetshospital Køge
Køge, Denmark, 4600
Not Yet Recruiting
2
Rygcenter Syddanmark, Middelfart Sygehus
Middelfart, Denmark, 5500
Actively Recruiting
Research Team
O
Oliver B Zielinski, MD
CONTACT
R
Rune D Bech, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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