Clinical trial NCT06959355: Frailty and Associated Factors in Lumbar Spinal Stenosis
Official title: Examination of Frailty and Related Factors in Lumbar Spinal Stenosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lumbar Spinal Stenosis
Lead sponsor: Karabuk University
Sponsor class: OTHER
First posted: 2025-05-06
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with LSS based on magnetic resonance imaging clinical evaluation will be included in the study.

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.

Detailed description: Lumbar spinal stenosis (LSS) is a degenerative disease that occurs due to compression of neurological structures as a result of narrowing of the spinal canal, and is particularly common in elderly individuals. LSS is characterized by pain, neurogenic claudication, decreased walking capacity, and functional disability. This condition can limit patients' daily living activities, leading to decreased physical activity levels, balance disorders, and increased fear of falling. At the same time, disability and decreased quality of life due to the disease can negatively affect individuals' physical and psychosocial health status, leading to increased frailty levels. Frailty is an important geriatric concept that requires multidisciplinary approaches and is associated with increased dependency and risk of falling in elderly individuals. Demonstrating the relationship between frailty and parameters such as pain, disability, quality of life, physical activity, balance, and fear of falling in individuals with LSS can contribute to the development of more effective rehabilitation strategies for the management of the disease.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Pain severity
timeFrame: Baseline
measure: Static balance
timeFrame: Baseline
measure: Dynamic balance
timeFrame: Baseline
measure: Disability
timeFrame: Baseline
measure: Fear of Falling
timeFrame: Baseline
measure: Health related quality of life
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Karabük
country: Turkey
facility: Karabuk University
Study officials:
affiliation: Karabuk University
name: Musa Gunes, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karabuk University
name: Aydın Sinan Apaydın, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.