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Completed

NCT Number: NCT06959355

Frailty and Associated 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.

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Key information

Conditions

Lumbar Spinal Stenosis Bone Diseases Musculoskeletal Diseases Spinal Diseases Spinal Stenosis

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Karabuk University

Karabük, 78050, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. Dynamic balance

    Time frame: Baseline

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

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Karabuk University

Other

Registry information

Official study title

Examination of Frailty and Related Factors in Lumbar Spinal Stenosis

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 6, 2025
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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