Frailty and Associated Factors in Lumbar Spinal Stenosis

NCT06959355 | Completed

• 1 other identifier: Karabuk-002
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

Lumbar spinal stenosis (LSS) is generally seen with advanced age, but it manifests itself with an increase in both physical and psychological health problems. Frailty is an important parameter that has become increasingly important in recent years and affects both the physical and psychological health of individuals. It has been examined in various disease groups in the literature and is reported to increase in patients with low back pain. However, the level of frailty and related factors in LSS are unknown. Since physical and psychological health are important in maintaining daily life, it is important to examine frailty in these individuals who present with chronic pain symptoms.

Conditions

Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (6)

• Pain severity

  Pain will be assessed with the numerical pain scale (NRS). NRS varies between 0-10. The higher the score, the greater the pain. Pain will be assessed with the numerical pain scale (NRS). NRS varies between 0-10. The higher the score, the greater the pain. Pain will be assessed with the numerical pain scale (NRS). NRS varies between 0-10. The higher the score, the greater the pain.

  Baseline

• Static balance

  Static balance will be assessed with the one-legged standing test. The test is terminated when it is 30 seconds or more, and there is a balance disorder below 10 seconds. Static balance will be assessed with the one-legged standing test. The test is terminated when it is 30 seconds or more, and there is a balance disorder below 10 seconds.

  Baseline

• Dynamic balance

  Dynamic balance will be assessed with Timed up and Go test. Time will be recorded in seconds

  Baseline

• Disability

  Disability will be assessed using the Oswestry Disability Index. The scale is scored from 0 to 100. A higher score indicates greater disability.

  Baseline

• Fear of Falling

  Fear of falling will be assessed with the Fall Efficacy Scale-International. It is scored between 16-64, the higher the score, the greater the fear of falling.

  Baseline

• Health related quality of life

  Quality of life will be assessed with Short Form-36. It is scored between 0-100, the higher the score, the higher the quality of life.

  Baseline

Study Arms (2)

Patients with frail LSS

Patients with LSS who are frail according to Fried criteria will be assigned to this group. According to the Frid criteria, patients who score 3 or more on the following symptoms have a frailty level: weight loss, weakness, exhaustion, decreased mobility, and physical inactivity.

Patients without frail LSS

Patients with LSS who are not frail according to Fried criteria will be assigned to this group.

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with LSS based on magnetic resonance imaging clinical evaluation will be included in the study.

You may qualify if:

• Patients diagnosed with lumbar spinal stenosis by MRI,
• Patients between the ages of 45-80,
• Patients who can stand independently,
• Volunteer to participate in the study

You may not qualify if:

• Patients who did not agree to participate in the study,
• Those with a chronic disease that would affect walking,
• Those who had undergone surgery in the lumbar region within the last year,
• Those with advanced joint disease in the lower extremity,
• Those with malignancy in the spine,
• Those with vision and/or vestibular system problems,
• Those who did not cooperate well were not included in the study.

Sponsors & Collaborators

• Karabuk University: lead

Study Sites (1)

Karabuk University

Karabük, 78050, Turkey (Türkiye)

Location

Related Publications (3)

• Kim HJ, Park S, Park SH, Lee JH, Chang BS, Lee CK, Yeom JS. The prevalence and impact of frailty in patients with symptomatic lumbar spinal stenosis. Eur Spine J. 2019 Jan;28(1):46-54. doi: 10.1007/s00586-018-5710-1. Epub 2018 Sep 1.

  PMID: 30173327 RESULT

• Leopoldino AAO, Megale RZ, Diz JBM, Moreira BS, Felicio DC, Queiroz BZ, Bastone AC, Ferreira ML, Pereira LSM. Influence of Frailty Status on Pain, Disability, and Quality of Life in Older Adults with Acute Low Back Pain: Results from the Back Complaints in the Elders (BACE-Brazil) Study. Can J Aging. 2021 Sep;40(3):367-375. doi: 10.1017/S0714980820000288. Epub 2020 Aug 14.

  PMID: 32792030 RESULT

• Nagai S, Kawabata S, Michikawa T, Ito K, Takeda H, Ikeda D, Kaneko S, Fujita N. Association between frailty and locomotive syndrome in elderly patients with lumbar spinal stenosis: A retrospective longitudinal analysis. Geriatr Gerontol Int. 2024 Jan;24(1):116-122. doi: 10.1111/ggi.14785. Epub 2023 Dec 23.

  PMID: 38140947 RESULT

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Musa Gunes, PhD

  Karabuk University

  PRINCIPAL INVESTIGATOR

• Aydın Sinan Apaydın, PhD

  Karabuk University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PhD

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 6, 2025
• Study Start: May 2, 2025
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)