Balance Amongst Patients With Lumbar Spinal Stenosis

NCT06075862 | Recruiting DMC

• 2 other identifiers: B-ATLAS1010-0194/22-3000
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

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 patient balance 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 postural balance in elderly patients with LSS. Measurements of postural balance 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 balance 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

Lumbar Spinal Stenosis

Keywords

Spinal stenosis; Elderly; Balance; Surgery

Outcome Measures

Primary Outcomes (1)

• Postural balance

  Postural balance, measured by sway area of center of pressure (mm\^2)

  Before surgery and 3, 6, 12 and 24 months after surgery

Secondary Outcomes (4)

• Postural balance

  Before surgery and 3, 6, 12 and 24 months after surgery

• Quality of life

  Before surgery and 3, 6, 12 and 24 months after surgery

• Functional disability

  Before surgery and 3, 6, 12 and 24 months after surgery

• Quality of life

  Before surgery and 3, 6, 12 and 24 months after surgery

Study Arms (1)

Patients with lumbar spinal stenosis

Patients diagnosed with lumbar spinal stenosis and referred to operation. Balance will be measured once in this group before operation, and four times again after operation.

Procedure: Decompressive surgery

Interventions

Decompressive surgery PROCEDURE

Decompressive lumbar spinal surgery

Patients with lumbar spinal stenosis

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients over 65 years of age referred to decompressive surgery for lumbar spinal stenosis

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)
• Mini Mental State Exam (MMSE) score of ≤ 27 points
• Degenerative spondylolisthesis more than 3mm on pre-operative imaging diagnostics

Sponsors & Collaborators

• Region Zealand: lead
• Region Syddanmark: collaborator

Study Sites (2)

Ortopædkirurgisk afdeling, Sjællands Universitetshospital Køge

Køge, 4600, Denmark

NOT YET RECRUITING

Rygcenter Syddanmark, Middelfart Sygehus

Middelfart, 5500, Denmark

RECRUITING

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MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Oliver B Zielinski, MD

  Region Zealand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oliver B Zielinski, MD

CONTACT

+4593931049; ozi@regionsjaelland.dk

Rune D Bech, MD, PhD

CONTACT

+4593931049; rudb@regionsjaelland.dk

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: October 10, 2023
• Study Start: September 21, 2023
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): May 1, 2028
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: A deidentified copy of all individual participant data will be kept by the authors of the study for 10 years following study end. After this time period, the full data set will be archived by the Danish National Archives with no planned end date.
• Access Criteria: Reasonable request for access can be made by writing to ozi@regionsjaelland.dk or rudb@regionsjaelland.dk in a time period consisting of 10 years after study end. After this period, requests for access can be made to the Danish National Archives at data@sa.dk.

Locations

DK (2)