Patients With Lumbar Spinal Stenosis With Balance Disorder

Lumbar Spinal Stenosis Clinical Trial

Official title:

Examination of Multifidus Muscle and Balance in Lumbar Spinal Stenosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06079580
• Other study ID #: Karabuk University-01
• Status: Completed
• Start date: September 1, 2023
• Est. completion date: January 15, 2024

Study information

• Verified date: April 2024
• Source: Karabuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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, 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.

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 The aim of our study is to examine the relationship between balance and biopsychosocial factors that can affect it.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: January 15, 2024
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Spinal Stenosis
• Spinal Stenosis

Locations

Country	Name	City	State
Turkey	Karabuk University, Physiotherapy and Rehabilitation Application and Research Center	Karabük

Sponsors (1)

Lead Sponsor	Collaborator
Karabuk University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Farrokhi MR, Haghnegahdar A, Rezaee H, Sharifi Rad MR. Spinal sagittal balance and spinopelvic parameters in patients with degenerative lumbar spinal stenosis; a comparative study. Clin Neurol Neurosurg. 2016 Dec;151:136-141. doi: 10.1016/j.clineuro.2016.10.020. Epub 2016 Oct 31. — View Citation

Ito T, Sakai Y, Yamazaki K, Oikawa M, Morita Y. Relationship Between L4/5 Lumbar Multifidus Cross-Sectional Area Ratio and Fall Risk in Older Adults with Lumbar Spinal Stenosis: A Retrospective Study. Geriatrics (Basel). 2019 Jun 21;4(2):38. doi: 10.3390/geriatrics4020038. — View Citation

Thornes E, Robinson HS, Vollestad NK. Dynamic balance in patients with degenerative lumbar spinal stenosis; a cross-sectional study. BMC Musculoskelet Disord. 2018 Jun 15;19(1):192. doi: 10.1186/s12891-018-2111-x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Static balance	The static balance of the patients will be evaluated with the 'Single Leg Standing Balance Test'.	First Day
Secondary	Dynamic balance	The dynamic balance of the patients will be evaluated with the 'Timed Up and Go Test (TUG)'.	First day
Secondary	Pain Severity	Evaluation of individuals' back and leg pain intensity will be done with the 'Numeric Rating Scale'.	First day
Secondary	Disability	Oswestry Disability Index will be used to evaluate the degree of loss of function that occurs with low back pain.	First day
Secondary	Faling	Fear of falling will be assessed with the International Fall Efficacy Scale (FES-I).	First day
Secondary	Muscle thickness	Multifidus muscle thickness at the L4/5 level will be evaluated using an MRI device.	First day
Secondary	Muscle cross-sectional area	Multifidus muscle cross-sectional area at the L4/5 level will be evaluated using an MRI device.	First day