Investigating Balance in Elderly Patients with Lumbar Spinal Stenosis
Postural Imbalance Amongst Elderly Patients With Symptomatic Lumbar Spinal Stenosis Before and After Decompressive Surgery
This study is testing how decompressive surgery affects balance in older adults with lumbar spinal stenosis before and after the procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Region Zealand Academic / other |
| Locations | 2 sites (Køge and 1 other locations) |
| Trial ID | NCT06075862 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on elderly patients suffering from lumbar spinal stenosis (LSS) and aims to assess the effects of decompressive surgery on their postural balance. It will measure balance before and after surgery, as well as at regular intervals during the recovery process. The study addresses a gap in current research regarding the objective evaluation of balance improvements following surgical intervention for LSS. By understanding these effects, the study seeks to enhance treatment strategies for this common degenerative condition.
Who should consider this trial
Good fit: Ideal candidates for this study are elderly patients aged 65 and older who are scheduled for decompressive spinal surgery due to symptomatic lumbar spinal stenosis.
Not a fit: Patients with severe comorbidities, recent spinal surgery, or cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and rehabilitation strategies for elderly patients with lumbar spinal stenosis, enhancing their balance and quality of life.
How similar studies have performed: While many studies have explored surgical outcomes for lumbar spinal stenosis, the specific focus on balance improvement post-surgery is less well-documented, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 65 years * Referred to decompressive spinal surgery due to symptomatic lumbar spinal stenosis at ≥ 1 level * Central canal LSS grade B or C (Schizas classification) at ≥ 1 level by Magnetic Resonance Imaging * Minimum of 3 months of unsuccessful non-operative treatment Exclusion Criteria: * Signs of malignancy or infection in the spinal column * Severe comorbidities incl. neurodegenerative conditions which may contribute to balance problems * Revision surgery (previous decompression surgery at the same vertebral level) * Spinal surgery up to 1 year prior to the date of inclusion * Mini Mental State Exam (MMSE) score of ≤ 27 points * Degenerative spondylolisthesis more than 3mm on pre-operative imaging diagnostics
Where this trial is running
Køge and 1 other locations
- Ortopædkirurgisk afdeling, Sjællands Universitetshospital Køge — Køge, Denmark (Not_yet_recruiting)
- Rygcenter Syddanmark, Middelfart Sygehus — Middelfart, Denmark (Recruiting)
Study contacts
- Principal investigator: Oliver B Zielinski, MD — Region Zealand
- Study coordinator: Oliver B Zielinski, MD
- Email: ozi@regionsjaelland.dk
- Phone: +4593931049
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.