Lumbar spinal stenosis.
Devin K Binder, Meic H Schmidt, Philip R Weinstein
https://pubmed.ncbi.nlm.nih.gov/12524561Actively Recruiting
Age: 65Years +
All Genders
ID06075862
Postural Imbalance 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 degenerative condition of the spine causing low back pain, poor balance, and reduced quality of life. This trial investigates how decompressive surgery affects postural balance in elderly patients with symptomatic LSS. While surgery's effects on pain and quality of life are known, its impact on balance is less studied. The study aims to measure balance changes before and after surgery over two years, hoping to better understand balance improvements and related quality of life benefits. Participants in this observational study undergo decompressive lumbar spinal surgery to relieve nerve pressure caused by LSS. Balance is assessed using the Wii Balance Board, a validated device for measuring postural sway, at one visit before surgery and at 3, 6, 12, and 24 months afterward. The study includes patients aged 65 and older with confirmed LSS at one or more spinal levels, who have had unsuccessful non-surgical treatments for at least three months. During the study, participants will have their postural balance tested multiple times using instrumented measures to track changes after surgery. Additional assessments include quality of life and functional disability questionnaires conducted at the same intervals. The follow-up period spans two years, allowing researchers to monitor long-term effects of surgery on balance and related outcomes. Safety and cognitive function are also evaluated to ensure appropriate participation and data quality.
CONDITIONS
Brief Title
Balance 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 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 inclusion
- Mini Mental State Exam 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
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 - Day of surgery and immediate recovery period
Participants undergo decompressive lumbar spinal surgery to relieve symptoms of lumbar spinal stenosis.
1 surgery day visit and immediate post-operative observation
Post-operative Follow-up
Duration - 24 months after surgery
Participants have their postural balance, quality of life, and functional disability assessed before surgery and at 3, 6, 12, and 24 months after surgery.
5 visits total: 1 before surgery and 4 follow-up visits after 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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Published Research Related To This Trial
Lumbar Spinal Stenosis: How Is It Classified?
Gregory D Schroeder, Mark F Kurd, Alexander R Vaccaro
https://pubmed.ncbi.nlm.nih.gov/27849674Spinal stenosis prevalence and association with symptoms: the Framingham Study.
Leonid Kalichman, Robert Cole, David H Kim...
https://pubmed.ncbi.nlm.nih.gov/19398386Prevalence of lumbar spinal stenosis, using the diagnostic support tool, and correlated factors in Japan: a population-based study.
Shoji Yabuki, Norio Fukumori, Misa Takegami...
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/21311394