Activity Levels Amongst Elderly Patients with Symptomatic Lumbar Spinal Stenosis Before and After Decompressive Surgery

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Ortopædkirurgisk afdeling, Sjællands Universitetshospital Køge
NOT_YET_RECRUITING
Køge
Rygcenter Syddanmark, Middelfart Sygehus
RECRUITING
Middelfart
Contact Information
Primary
Oliver B Zielinski, MD
ozi@regionsjaelland.dk
+4593931049
Backup
Rune D Bech, MD, PhD
rudb@regionsjaelland.dk
+4593931049
Time Frame
Start Date: 2023-09-21
Estimated Completion Date: 2028-04
Participants
Target number of participants: 80
Treatments
Patients with lumbar spinal stenosis
Patients diagnosed with lumbar spinal stenosis and referred to operation. Measurements of activity levels will be undertaken before operation, and compared to after operation.
Related Therapeutic Areas
Sponsors
Leads: Region Zealand
Collaborators: Region Syddanmark

This content was sourced from clinicaltrials.gov