Lumbar Spinal StenosisNCT06079580
Patients With Lumbar Spinal Stenosis With Balance Disorder
An observational study of Lumbar Spinal Stenosis, run by Karabuk University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lumbar Spinal Stenosis
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 15 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Lumbar Spinal Stenosis
Who may be able to join
- Diagnosed with L4/5 lumbar spinal stenosis by MRI,
- Patients who can stand independently
- Volunteering to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karabuk University, Physiotherapy and Rehabilitation Application and Research Center
Karabük
About this study
Official title: Examination of Multifidus Muscle and Balance in Lumbar Spinal Stenosis
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.
Read the 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 The aim of our study is to examine the relationship between balance and biopsychosocial factors that can affect it.
- Conditions
- Lumbar Spinal Stenosis
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static balance
The static balance of the patients will be evaluated with the 'Single Leg Standing Balance Test'.
Measured: First Day
Secondary outcomes (6)
Dynamic balance
The dynamic balance of the patients will be evaluated with the 'Timed Up and Go Test (TUG)'.
Measured: First day
Pain Severity
Evaluation of individuals' back and leg pain intensity will be done with the 'Numeric Rating Scale'.
Measured: First day
Disability
Oswestry Disability Index will be used to evaluate the degree of loss of function that occurs with low back pain.
Measured: First day
Faling
Fear of falling will be assessed with the International Fall Efficacy Scale (FES-I).
Measured: First day
Muscle thickness
Multifidus muscle thickness at the L4/5 level will be evaluated using an MRI device.
Measured: First day
Muscle cross-sectional area
Multifidus muscle cross-sectional area at the L4/5 level will be evaluated using an MRI device.
Measured: First day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start1 Sep 2023
- Primary completion15 Dec 2023
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Musa Güneş, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06079580
- Sponsor's protocol ID
- Karabuk University-01
- Status last verified
- Apr 2024
- First submitted
- 6 Oct 2023
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27842292Thornes 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.
PubMed 29902972Ito 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.
PubMed 31234297
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Multifidus Muscle and Balance in Lumbar Spinal Stenosis
- ClinicalTrials.gov ID
- NCT06079580
- Acronym / sponsor ID
- Karabuk University-01
- Conditions
- Lumbar Spinal Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 The aim of our study is to examine the relationship between balance and biopsychosocial factors that can affect it.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Lumbar Spinal Stenosis
Key inclusion criteria (3 listed)
- Diagnosed with L4/5 lumbar spinal stenosis by MRI,
- Patients who can stand independently
- Volunteering to participate in the study
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Static balance
Time frame: First Day
The static balance of the patients will be evaluated with the 'Single Leg Standing Balance Test'.
6 secondary outcomes
Dynamic balance
Time frame: First day
Pain Severity
Time frame: First day
Disability
Time frame: First day
Faling
Time frame: First day
Muscle thickness
Time frame: First day
Muscle cross-sectional area
Time frame: First day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Background: PubMed 27842292Farrokhi 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.
- Background: PubMed 29902972Thornes 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.
- Background: PubMed 31234297Ito 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Spinal Stenosis, run by Karabuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static balance (time frame: First Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06079580, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.