Activity Levels Amongst Patients With Lumbar Spinal Stenosis

Recruiting now

Conditions studied: Lumbar Spinal Stenosis

In brief

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.

Key facts

Study ID

NCT06057428

Run by

Region Zealand

People needed

80

Starts

2023-09-21

Expected to finish

2028-12-01

Last updated by the study team

2026-06-03

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Rygcenter Syddanmark, Middelfart Sygehus — Middelfart, Denmark (enrolling)
• Ortopædkirurgisk afdeling, Sjællands Universitetshospital Køge — Køge, Denmark

Full record on ClinicalTrials.gov

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