Lumbar Spinal StenosisNCT06959355
Frailty and Associated Factors in Lumbar Spinal Stenosis
An observational study of Lumbar Spinal Stenosis, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Lumbar Spinal Stenosis
- How many people
- 91 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 May 2025to 30 Jul 2025
- 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
- Adult, Older adult
Study population: Patients diagnosed with LSS based on magnetic resonance imaging clinical evaluation will be included in the study.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examination of Frailty and Related 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.
Read the detailed description
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.
- 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 frail LSS | Patients with LSS who are frail according to Fried criteria will be assigned to this group. According to the Frid criteria, patients who score 3 or more on the following symptoms have a frailty level: weight loss, weakness, exhaustion, decreased mobility, and physical inactivity. | |
| Patients without frail LSS | Patients with LSS who are not frail according to Fried criteria will be assigned to this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain severity
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.
Measured: Baseline
Static balance
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.
Measured: Baseline
Dynamic balance
Dynamic balance will be assessed with Timed up and Go test. Time will be recorded in seconds
Measured: Baseline
Disability
Disability will be assessed using the Oswestry Disability Index. The scale is scored from 0 to 100. A higher score indicates greater disability.
Measured: Baseline
Fear of Falling
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.
Measured: Baseline
Health related quality of life
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start2 May 2025
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Musa Güneş, Karabuk University
- Investigators
- Musa Gunes, PhD, Principal investigator, Karabuk UniversityAydın Sinan Apaydın, PhD, Principal investigator, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06959355
- Sponsor's protocol ID
- Karabuk-002
- Status last verified
- Apr 2026
- First submitted
- 28 Apr 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim HJ, Park S, Park SH, Lee JH, Chang BS, Lee CK, Yeom JS. The prevalence and impact of frailty in patients with symptomatic lumbar spinal stenosis. Eur Spine J. 2019 Jan;28(1):46-54. doi: 10.1007/s00586-018-5710-1. Epub 2018 Sep 1.
PubMed 30173327Leopoldino AAO, Megale RZ, Diz JBM, Moreira BS, Felicio DC, Queiroz BZ, Bastone AC, Ferreira ML, Pereira LSM. Influence of Frailty Status on Pain, Disability, and Quality of Life in Older Adults with Acute Low Back Pain: Results from the Back Complaints in the Elders (BACE-Brazil) Study. Can J Aging. 2021 Sep;40(3):367-375. doi: 10.1017/S0714980820000288. Epub 2020 Aug 14.
PubMed 32792030Nagai S, Kawabata S, Michikawa T, Ito K, Takeda H, Ikeda D, Kaneko S, Fujita N. Association between frailty and locomotive syndrome in elderly patients with lumbar spinal stenosis: A retrospective longitudinal analysis. Geriatr Gerontol Int. 2024 Jan;24(1):116-122. doi: 10.1111/ggi.14785. Epub 2023 Dec 23.
PubMed 38140947
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Frailty and Related Factors in Lumbar Spinal Stenosis
- ClinicalTrials.gov ID
- NCT06959355
- Acronym / sponsor ID
- Karabuk-002
- Conditions
- Lumbar Spinal Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 2 May 2025 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 6 May 2025 (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.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with frail LSS | – | –Patients with LSS who are frail according to Fried criteria will be assigned to this group. According to the Frid criteria, patients who score 3 or more on the following symptoms have a frailty level: weight loss, weakness, exhaustion, decreased mobility, and physical inactivity. |
| Patients without frail LSS | – | –Patients with LSS who are not frail according to Fried criteria will be assigned to this group. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with LSS based on magnetic resonance imaging clinical evaluation will be included in the study.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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,
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
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.
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.
Dynamic balance
Time frame: Baseline
Dynamic balance will be assessed with Timed up and Go test. Time will be recorded in seconds
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.
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.
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.
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 22 Apr 2026.
- Results publication: PubMed 30173327Kim HJ, Park S, Park SH, Lee JH, Chang BS, Lee CK, Yeom JS. The prevalence and impact of frailty in patients with symptomatic lumbar spinal stenosis. Eur Spine J. 2019 Jan;28(1):46-54. doi: 10.1007/s00586-018-5710-1. Epub 2018 Sep 1.
- Results publication: PubMed 32792030Leopoldino AAO, Megale RZ, Diz JBM, Moreira BS, Felicio DC, Queiroz BZ, Bastone AC, Ferreira ML, Pereira LSM. Influence of Frailty Status on Pain, Disability, and Quality of Life in Older Adults with Acute Low Back Pain: Results from the Back Complaints in the Elders (BACE-Brazil) Study. Can J Aging. 2021 Sep;40(3):367-375. doi: 10.1017/S0714980820000288. Epub 2020 Aug 14.
- Results publication: PubMed 38140947Nagai S, Kawabata S, Michikawa T, Ito K, Takeda H, Ikeda D, Kaneko S, Fujita N. Association between frailty and locomotive syndrome in elderly patients with lumbar spinal stenosis: A retrospective longitudinal analysis. Geriatr Gerontol Int. 2024 Jan;24(1):116-122. doi: 10.1111/ggi.14785. Epub 2023 Dec 23.
- 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.
Musa Gunes, PhD principal investigator
Karabuk University
Aydın Sinan Apaydın, PhD principal investigator
Karabuk University
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 4 inclusion and 7 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 22 Apr 2026. 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?
Pain severity (time frame: Baseline). The study lists 6 primary outcomes in all. 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 NCT06959355, 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 22 Apr 2026.