Actively Recruiting

Age: 65Years +
All Genders
NCT06057428

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

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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