Patients With Lumbar Spinal Stenosis With Balance Disorder

Sponsor
Karabuk University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06079580
Collaborator
(none)
62
1
5
12.5

Study Details

Study Description

Brief Summary

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, biopsychosocial factors such as pain, disability and fear of falling in balance disorders have not been adequately explained. The aim of our study is to compare the results of muscle thickness and cross-sectional area, pain, disability and fear of falling in patients with LSS with and without balance problems and to examine the relationship between them.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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 compare the results of muscle thickness and cross-sectional area, pain, disability and fear of falling in patients with LSS with and without balance problems and to examine the relationship between them.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    62 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Investigation of Lumbar Multifidus Muscle, Pain and Fear of Falling in Patients With Lumbar Spinal Stenosis With Balance Disorder
    Actual Study Start Date :
    Sep 1, 2023
    Anticipated Primary Completion Date :
    Nov 15, 2023
    Anticipated Study Completion Date :
    Jan 30, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with Lumbar spinal stenosis with balance disorders

    According to the single-leg balance test, patients who maintain static balance for less than 10 seconds will be grouped as having impaired balance.

    Patients with Lumbar spinal stenosis with normal balance

    According to the single-leg balance test, patients who maintain their static balance for more than 10 seconds will be grouped as having normal balance.

    Outcome Measures

    Primary Outcome Measures

    1. Static balance [First Day]

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

    Secondary Outcome Measures

    1. Dynamic balance [First day]

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

    2. Pain Severity [First day]

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

    3. Disability [First day]

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

    4. Faling [First day]

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

    5. Muscle thickness [First day]

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

    6. Muscle cross-sectional area [First day]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Karabuk University, Physiotherapy and Rehabilitation Application and Research Center Karabük Turkey

    Sponsors and Collaborators

    • Karabuk University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Musa Güneş, Study director, PT, MsC, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Karabuk University
    ClinicalTrials.gov Identifier:
    NCT06079580
    Other Study ID Numbers:
    • Karabuk University-01
    First Posted:
    Oct 12, 2023
    Last Update Posted:
    Oct 12, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 12, 2023