Activity Levels Amongst Patients With Lumbar Spinal Stenosis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorRegion Zealand

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Decompressive surgery

Treatment groups

80 Participants
are divided into 1 treatment group

Sponsors and collaborators

Region Zealand

Lead sponsor

Region Syddanmark

Collaborator