Skip to main content
Clinical Trials/NCT06959355
NCT06959355CompletedNot Applicable

Examination of Frailty and Related Factors in Lumbar Spinal Stenosis

Karabuk University1 site in 1 country91 target enrollmentStarted: May 2, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
91
Locations
1
Primary Endpoint
Dynamic balance

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
45 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

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.

Outcomes

Primary Outcomes

Dynamic balance

Time Frame: Baseline

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

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.

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.

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.

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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Karabuk University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Musa Güneş

Principal Investigator, PhD

Karabuk University

Study Sites (1)

Loading locations...

Similar Trials