NCT06057428 Activity Levels Amongst Patients With Lumbar Spinal Stenosis
| NCT ID | NCT06057428 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Region Zealand |
| Condition | Lumbar Spinal Stenosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-09-21 |
| Primary Completion | 2028-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2023-09-21 with a primary completion date of 2028-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Oliver B Zielinski, MD
PRINCIPAL INVESTIGATOR
Orthopaedic Department, Zealand University Hospital
Frequently Asked Questions
Who can join the NCT06057428 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Lumbar Spinal Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06057428 currently recruiting?
Yes, NCT06057428 is actively recruiting participants. Contact the research team at ozi@regionsjaelland.dk for enrollment information.
Where is the NCT06057428 trial being conducted?
This trial is being conducted at Køge, Denmark, Middelfart, Denmark.
Who is sponsoring the NCT06057428 clinical trial?
NCT06057428 is sponsored by Region Zealand. The principal investigator is Oliver B Zielinski, MD at Orthopaedic Department, Zealand University Hospital. The trial plans to enroll 80 participants.