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Completed

NCT Number: NCT06079580

Patients With Lumbar Spinal Stenosis With Balance Disorder

It is seen that patients with Lumbar Spinal Stenosis often experience balance problems. Although the relationship between muscle thickness and balance has been explained, there are insufficient studies investigating the relationship between balance problems and muscle thickness in patients with LSS. In addition, no study has been found comparing the difference in muscle thickness and cross-sectional area in LSS patients with poor and normal balance. In addition, in LSS, pain, disability and fear of falling in balance disorders are nor clear. The aim of our study is to examine the relationship between balance and biopsychosocial factors that can affect it.

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Key information

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Karabuk University, Physiotherapy and Rehabilitation Application and Research Center

Karabük, Turkey (Türkiye)

About this study

The stability and balance of the lumbar spine depends on the paraspinal muscles surrounding it. In addition, the atrophy of the muscle in this area leads to deterioration of the body's stability. The multifidus muscle is important for the lumbar region due to its multiple connections. Today, morphological factors of paraspinal muscles are being investigated. The degeneration occurring in these muscles also causes a decrease in the thickness and cross-sectional areas of the muscle. This condition is associated with loss of balance in various populations. However, this relationship has not been adequately investigated in patients with lumbar spinal stenosis. At the same time, the intensity of pain affects balance and causes disruptions. Balance problems in older adults can lead to falls, leading to vertebral and femoral neck fractures. These injuries cause a decrease in quality of life. When the literature is examined, it is seen that patients with LSS often have balance problems. Parameters such as muscle mass, pain, disability and fear of falling affect this factor. However, although the relationship between muscle thickness and balance has been described in various populations, there are insufficient studies investigating the relationship between balance problems and muscle thickness in patients with LSS. In addition, no study has been found comparing the difference in muscle thickness and cross-sectional area in LSS patients with poor and normal balance. In addition, it is observed that biopsychosocial factors such as pain, disability and fear of falling in balance disorders are not adequately explained. In this context, our study aims to The aim of our study is to examine the relationship between balance and biopsychosocial factors that can affect it.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Diagnosed with L4/5 lumbar spinal stenosis by MRI,
  • Patients who can stand independently
  • Volunteering to participate in the study

Exclusion criteria

  • Patients who did not agree to participate in the study,
  • Having a history of serious neurological diseases such as Parkinson's, hemiplegia, multiple sclerosis,
  • Having undergone a surgical operation on the lumbar region within the last year,
  • Having severe joint disorders in the lower extremities,
  • Having malignancy in the spine,
  • Having had an operation on the lower extremity,
  • Having vision and/or vestibular system problems,
  • Those who do not cooperate well

Treatment and study plan

Primary outcomes

  1. Static balance

    Time frame: First Day

    The static balance of the patients will be evaluated with the 'Single Leg Standing Balance Test'.

Secondary outcomes

  1. Dynamic balance

    Time frame: First day

    The dynamic balance of the patients will be evaluated with the 'Timed Up and Go Test (TUG)'.

  2. Pain Severity

    Time frame: First day

    Evaluation of individuals' back and leg pain intensity will be done with the 'Numeric Rating Scale'.

  3. Disability

    Time frame: First day

    Oswestry Disability Index will be used to evaluate the degree of loss of function that occurs with low back pain.

  4. Faling

    Time frame: First day

    Fear of falling will be assessed with the International Fall Efficacy Scale (FES-I).

  5. Muscle thickness

    Time frame: First day

    Multifidus muscle thickness at the L4/5 level will be evaluated using an MRI device.

  6. Muscle cross-sectional area

    Time frame: First day

    Multifidus muscle cross-sectional area at the L4/5 level will be evaluated using an MRI device.

Sponsors and collaborators

Lead sponsor

Karabuk University

Other

Registry information

Official study title

Examination of Multifidus Muscle and Balance in Lumbar Spinal Stenosis

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Oct 12, 2023
Registry last updated
Apr 25, 2024

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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