Frailty and Associated Factors in Lumbar Spinal Stenosis

NCT ID: NCT06959355

Last Updated: 2025-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-02

Study Completion Date

2025-11-15

Brief Summary

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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

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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.

Conditions

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Lumbar Spinal Stenosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

No interventions assigned to this group

Patients without frail LSS

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karabuk University

OTHER

Sponsor Role lead

Responsible Party

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Musa Güneş

Principal Investigator, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Musa Gunes, PhD

Role: PRINCIPAL_INVESTIGATOR

Karabuk University

Aydın Sinan Apaydın, PhD

Role: PRINCIPAL_INVESTIGATOR

Karabuk University

Locations

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Karabuk University

Karabük, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Musa Güneş, PhD

Role: CONTACT

+905315132482

Facility Contacts

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Musa Güneş, PhD

Role: primary

+905315132482

References

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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.

Reference Type RESULT
PMID: 30173327 (View on PubMed)

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.

Reference Type RESULT
PMID: 32792030 (View on PubMed)

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.

Reference Type RESULT
PMID: 38140947 (View on PubMed)

Other Identifiers

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Karabuk-002

Identifier Type: -

Identifier Source: org_study_id

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