Frailty and Associated Factors in Lumbar Spinal Stenosis

April 17, 2026 updated by: Musa Güneş, Karabuk University

Examination of Frailty and Related Factors in Lumbar Spinal Stenosis

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

91

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain severity
Time Frame: Baseline

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
Time Frame: Baseline

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karabuk University

Investigators

  • Principal Investigator: Aydın Sinan Apaydın, PhD, Karabuk University
  • Principal Investigator: Musa Güneş, PhD, Karabuk University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2025

Primary Completion (Actual)

July 30, 2025

Study Completion (Actual)

July 30, 2025

Study Registration Dates

First Submitted

April 28, 2025

First Submitted That Met QC Criteria

April 28, 2025

First Posted (Actual)

May 6, 2025

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Karabuk-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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