Lumbar spinal stenosis.
Devin K Binder, Meic H Schmidt, Philip R Weinstein
https://pubmed.ncbi.nlm.nih.gov/12524561Actively Recruiting
Age: 65Years +
All Genders
ID06057428
Activity Levels Amongst Elderly Patients With Symptomatic Lumbar Spinal Stenosis Before and After Decompressive Surgery
Led by Region Zealand · Updated on 2026-06-03
80
Participants Needed
2
Research Sites
17 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 a common age-related condition causing low back pain, poor balance, and reduced activity, which significantly lowers quality of life. This research aims to study how decompressive surgery affects activity levels in elderly patients with symptomatic LSS. The study addresses gaps in understanding the surgery's impact on physical activity, beyond known improvements in pain and disability. Participants in this observational study will undergo decompressive surgery for lumbar spinal stenosis. Activity levels will be measured before surgery and at 3, 6, 12, and 24 months after surgery using accelerometers, which provide detailed activity data. This long-term follow-up allows researchers to observe changes in physical activity over two years. During the study, participants' physical activity, inactivity, quality of life, functional disability, and self-reported activity will be regularly assessed. These evaluations will use objective device measurements and questionnaires. The study will monitor changes from before surgery through the two-year follow-up to understand how surgery influences activity and well-being in elderly LSS patients.
CONDITIONS
Brief Title
Activity Levels Amongst Patients With Lumbar Spinal Stenosis
Who Can Participate
Age: 65Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 65 years or older
- Referred to decompressive spinal surgery due to symptomatic lumbar spinal stenosis at one or more levels
- Central canal lumbar spinal stenosis grade B or C at one or more levels confirmed by MRI
- 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 decompression surgery at the same vertebral level (revision surgery)
- Spinal surgery within 1 year prior to study inclusion
- Mini Mental State Exam (MMSE) score less than or equal to 27
- Degenerative spondylolisthesis greater than 3mm on pre-operative imaging
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Up to discharge after surgery
Participants undergo decompressive surgery for lumbar spinal stenosis and receive immediate post-operative care.
1 surgery visit and immediate post-operative care
Post-operative Follow-up
Duration - 24 months
Participants are monitored for changes in activity levels, physical activity, quality of life, functional disability, and self-reported activity before surgery and at 3, 6, 12, and 24 months after surgery.
Visits at 3, 6, 12, and 24 months post-surgery
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
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Research Team
O
Oliver B Zielinski, MD
R
Rune D Bech, MD, PhD
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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https://pubmed.ncbi.nlm.nih.gov/27849674Prevalence of lumbar spinal stenosis, using the diagnostic support tool, and correlated factors in Japan: a population-based study.
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https://pubmed.ncbi.nlm.nih.gov/23963588Degenerative lumbar spinal stenosis. Diagnostic value of the history and physical examination.
J N Katz, M Dalgas, G Stucki...
https://pubmed.ncbi.nlm.nih.gov/7575718Management of lumbar spinal stenosis.
Jon Lurie, Christy Tomkins-Lane
https://pubmed.ncbi.nlm.nih.gov/26727925Lumbar Spinal Stenosis: Pathophysiology and Treatment Principle: A Narrative Review.
Byung Ho Lee, Seong-Hwan Moon, Kyung-Soo Suk...
https://pubmed.ncbi.nlm.nih.gov/33108834Lumbar canal stenosis: start with nonsurgical therapy.
Daniel J Mazanec, Vinod K Podichetty, Augusto Hsia
https://pubmed.ncbi.nlm.nih.gov/12430977Steroid for epidural injection in spinal stenosis: a systematic review and meta-analysis.
Kuan Liu, Pengcheng Liu, Run Liu...
https://pubmed.ncbi.nlm.nih.gov/25678775Surgery versus conservative treatment for symptomatic lumbar spinal stenosis: a systematic review of randomized controlled trials.
Francisco M Kovacs, Gerard Urrútia, José Domingo Alarcón
https://pubmed.ncbi.nlm.nih.gov/21311394Lumbar spinal stenosis. Treatment strategies and indications for surgery.
Dilip K Sengupta, Harry N Herkowitz
https://pubmed.ncbi.nlm.nih.gov/12914268