Spinal Stenosis LumbarNCT05548608
Lumbar Proprioception in Patients With Lumbar Spinal Stenosis
An observational study of Spinal Stenosis Lumbar, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of this study was to compare spinal proprioception in patients with Lumbal Spinal Stenosis (LSS) (with or without surgery) and healthy controls. A secondary aim was to investigate the effect of pain at target positions where repositioning error (RE) was assessed and TLF flexibility on spinal… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Stenosis Lumbar
- What is being tested?
- Reposition error (RE), pain at target positions of RE and flexibility of the TLF were assesed with iphone tiltmeter app, VAS and goniometric platform, respectively.
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Sep 2020to 10 Feb 2021
- How long will I take part?
- 1 Day
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Group I consists of patient relatives and patients who applied to the outpatient clinic for another ailment. Group II consisted of patients diagnosed with LSS and confirmed by MRI findings. Participants who have undergone surgery due to LSS were included in Group III.
Who may be able to join
- age between 20 and 50 years
- not having had lower extremity surgery
- not having a chronic spinal disorders
- not having low back pain in the last week
- having low back pain for more than 3 months
- having low back pain intensity of 4 or more assessed with VAS
Who cannot join
- .having any previous inner ear inflammation or vestibular disorders .having diabetes and being pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Different Injury Mechanism on Lumbar Proprioception in Patients With Lumbar Spinal Stenosis: an Observational Healthy Controlled Study
The primary aim of this study was to compare spinal proprioception in patients with Lumbal Spinal Stenosis (LSS) (with or without surgery) and healthy controls. A secondary aim was to investigate the effect of pain at target positions where repositioning error (RE) was assessed and TLF flexibility on spinal proprioception deficiency.This cross-sectional and healthy controlled study was conducted in patients with LSS. Participants will be grouped as: Healthy control (Group I), chronic low back pain due to LSS (Group II) and undergoing surgery due to LSS (Group III). Reposition error (RE), pain at target positions of RE and flexibility of the TLF were assesed with iphone tiltmeter app, VAS and goniometric platform, respectively. Target positions of reposition error were: 30º forward bending and 15º backward bending in sitting and standing.
Read the detailed description
This cross-sectional and healthy controlled study was conducted in patients with LSS. Participants will be grouped as: Healthy control (Group I), chronic low back pain due to LSS (Group II) and undergoing surgery due to LSS (Group III). Reposition error (RE), pain at target positions of RE and flexibility of the TLF were assesed with iphone tiltmeter app, VAS and goniometric platform, respectively. Target positions of reposition error were: 30º forward bending and 15º backward bending in sitting and standing.
The general study inclusion criteria were as follows: age between 20 and 50 years and not having had lower extremity surgery.
In addition to the general inclusion criteria, the inclusion criteria for the control group were as follows: not having a chronic spinal disorders and not having low back pain in the last week. Group II consisted of patients diagnosed with LSS and confirmed by MRI findings.
In addition to the general inclusion criteria, the inclusion criteria for the LSS group were as follows: having low back pain for more than 3 months and having low back pain intensity of 4 or more assessed with VAS.
There was not any additional inclussion criteria for Group III. The exclusion criteria of current study are; having any previous inner ear inflammation or vestibular disorders, having diabetes and being pregnant.
- Conditions
- Spinal Stenosis Lumbar
- Being tested
- Reposition error (RE), pain at target positions of RE and flexibility of the TLF were assesed with iphone tiltmeter app, VAS and goniometric platform, respectively.
- Keywords
- Lumbar spinal stenosis, proprioception, reposition error
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reposition error (RE), pain at target positions of RE and flexibility of the TLF were assesed with iphone tiltmeter app, VAS and goniometric platform, respectively.Other
Target positions of reposition error were: 30º forward bending and 15º backward bending in sitting and standing.
| Study group | Role | What they receive |
|---|---|---|
| Group I (Healthy control) | Group I consists of patient relatives and patients who applied to the outpatient clinic for another ailment. Receives: Other: Reposition error (RE), pain at target positions of RE and flexibility of the TLF were assesed with iphone tiltmeter app, VAS and goniometric platform, respectively. | |
| Group II (chronic low back pain due to LSS ) | Group II consisted of patients diagnosed with LSS and confirmed by MRI findings. Receives: Other: Reposition error (RE), pain at target positions of RE and flexibility of the TLF were assesed with iphone tiltmeter app, VAS and goniometric platform, respectively. | |
| Group III (undergoing surgery due to LSS ) | Participants who had surgery for LSS at least 3 months ago were included in Group III. Receives: Other: Reposition error (RE), pain at target positions of RE and flexibility of the TLF were assesed with iphone tiltmeter app, VAS and goniometric platform, respectively. |
What is being measured
The primary outcome is the main question the study is designed to answer.
reposition error
Reposition error was asessed by measuring the difference in angles between the target position and the re-produced position. Target positions were 30º forward bending and 15º backward bending in sitting and standing positions. The target and the reproduced angles were measured with the iPhone tilt-meter application.
Measured: september 2020-february 2021
pain intensity
. Pain intensity was assessed with the 10 cm horizontal Visual Analogue Scale (VAS) at target positions (during sitting and standing in combination with forward and backward bending)
Measured: september 2020-february 2021
flexibility of the TLF
Flexibility of the TLF was evaluated with goniometric platform. The participant was asked to sit on a height-adjustable chair with the hip and knee flexed at 90º and the lumbar region in a neutral position. The goniometric platform was placed on the table in front of the participant. The therapist fixed the posterior superior iliac spines of the participant. And then participants were asked to hold the hands in front of the body (90° shoulder flexion) with a pen clamped between the hands. Participants were warned that the arms should follow the trunk rotation. Participants performed trunk rotation 3 times in the same direction and marked the point on the goniometric platform. The mean of the 3 measurements was calculated. The same protocol was repeated in the opposite direction.
Measured: september 2020-february 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start10 Sep 2020
- Primary completion10 Nov 2020
- Study completion10 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Spinal Stenosis LumbarStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şule ŞİMŞEK, Pamukkale University
- Investigators
- Şule Şimşek, Phd, Principal investigator, PhD faculty member
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548608
- Sponsor's protocol ID
- 28.07.2020/14
- Status last verified
- Sep 2022
- First submitted
- 15 Sep 2022
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee AS, Cholewicki J, Reeves NP, Zazulak BT, Mysliwiec LW. Comparison of trunk proprioception between patients with low back pain and healthy controls. Arch Phys Med Rehabil. 2010 Sep;91(9):1327-31. doi: 10.1016/j.apmr.2010.06.004.
PubMed 20801248Sarioglu K, Pekyavas NO. A Comparison Between People With and Without Subacromial Impingement Syndrome and a New Method for Measuring Thoracolumbar Fascia Flexibility. J Chiropr Med. 2021 Mar;20(1):9-15. doi: 10.1016/j.jcm.2021.01.003. Epub 2021 May 12.
PubMed 34025300Noh KH, Oh JS, Yoo WG. Comparison of lumbar repositioning error according to different lumbar angles in a flexion pattern (FP) subgroup of patients with non-specific chronic low back pain. J Phys Ther Sci. 2015 Jan;27(1):293-4. doi: 10.1589/jpts.27.293. Epub 2015 Jan 9.
PubMed 25642094Georgy EE. Lumbar repositioning accuracy as a measure of proprioception in patients with back dysfunction and healthy controls. Asian Spine J. 2011 Dec;5(4):201-7. doi: 10.4184/asj.2011.5.4.201. Epub 2011 Nov 28.
PubMed 22164313
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Injury Mechanism on Lumbar Proprioception in Patients With Lumbar Spinal Stenosis: an Observational Healthy Controlled Study
- ClinicalTrials.gov ID
- NCT05548608
- Acronym / sponsor ID
- 28.07.2020/14
- Conditions
- Spinal Stenosis Lumbar
- Keywords
- Lumbar spinal stenosis, proprioception, reposition error
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 10 Nov 2020 (actual)
- Study completion
- 10 Feb 2021 (actual)
- First posted
- 21 Sep 2022 (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.
The primary aim of this study was to compare spinal proprioception in patients with Lumbal Spinal Stenosis (LSS) (with or without surgery) and healthy controls. A secondary aim was to investigate the effect of pain at target positions where repositioning error (RE) was assessed and TLF flexibility on spinal proprioception deficiency.This cross-sectional and healthy controlled study was conducted in patients with LSS. Participants will be grouped as: Healthy control (Group I), chronic low back pain due to LSS (Group II) and undergoing surgery due to LSS (Group III). Reposition error (RE), pain at target positions of RE and flexibility of the TLF were assesed with iphone tiltmeter app, VAS and goniometric platform, respectively. Target positions of reposition error were: 30º forward bending and 15º backward bending in sitting and standing.
Detailed description
This cross-sectional and healthy controlled study was conducted in patients with LSS. Participants will be grouped as: Healthy control (Group I), chronic low back pain due to LSS (Group II) and undergoing surgery due to LSS (Group III). Reposition error (RE), pain at target positions of RE and flexibility of the TLF were assesed with iphone tiltmeter app, VAS and goniometric platform, respectively. Target positions of reposition error were: 30º forward bending and 15º backward bending in sitting and standing.
The general study inclusion criteria were as follows: age between 20 and 50 years and not having had lower extremity surgery.
In addition to the general inclusion criteria, the inclusion criteria for the control group were as follows: not having a chronic spinal disorders and not having low back pain in the last week. Group II consisted of patients diagnosed with LSS and confirmed by MRI findings.
In addition to the general inclusion criteria, the inclusion criteria for the LSS group were as follows: having low back pain for more than 3 months and having low back pain intensity of 4 or more assessed with VAS.
There was not any additional inclussion criteria for Group III. The exclusion criteria of current study are; having any previous inner ear inflammation or vestibular disorders, having diabetes and being pregnant.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I (Healthy control) | – | Other: Reposition error (RE), pain at target positions of RE and flexibility of the TLF were assesed with iphone tiltmeter app, VAS and goniometric platform, respectively.Group I consists of patient relatives and patients who applied to the outpatient clinic for another ailment. |
| Group II (chronic low back pain due to LSS ) | – | Other: Reposition error (RE), pain at target positions of RE and flexibility of the TLF were assesed with iphone tiltmeter app, VAS and goniometric platform, respectively.Group II consisted of patients diagnosed with LSS and confirmed by MRI findings. |
| Group III (undergoing surgery due to LSS ) | – | Other: Reposition error (RE), pain at target positions of RE and flexibility of the TLF were assesed with iphone tiltmeter app, VAS and goniometric platform, respectively.Participants who had surgery for LSS at least 3 months ago were included in Group III. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Group I consists of patient relatives and patients who applied to the outpatient clinic for another ailment. Group II consisted of patients diagnosed with LSS and confirmed by MRI findings. Participants who have undergone surgery due to LSS were included in Group III.
Key inclusion criteria (6 listed)
- age between 20 and 50 years
- not having had lower extremity surgery
- not having a chronic spinal disorders
- not having low back pain in the last week
- having low back pain for more than 3 months
Key exclusion criteria (1 listed)
- .having any previous inner ear inflammation or vestibular disorders .having diabetes and being pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reposition error (RE), pain at target positions of RE and flexibility of the TLF were assesed with iphone tiltmeter app, VAS and goniometric platform, respectively.Target positions of reposition error were: 30º forward bending and 15º backward bending in sitting and standing. | Other | Group I (Healthy control), Group II (chronic low back pain due to LSS ), Group III (undergoing surgery due to LSS ) |
Primary outcome
reposition error
Time frame: september 2020-february 2021
Reposition error was asessed by measuring the difference in angles between the target position and the re-produced position. Target positions were 30º forward bending and 15º backward bending in sitting and standing positions. The target and the reproduced angles were measured with the iPhone tilt-meter application.
pain intensity
Time frame: september 2020-february 2021
. Pain intensity was assessed with the 10 cm horizontal Visual Analogue Scale (VAS) at target positions (during sitting and standing in combination with forward and backward bending)
flexibility of the TLF
Time frame: september 2020-february 2021
Flexibility of the TLF was evaluated with goniometric platform. The participant was asked to sit on a height-adjustable chair with the hip and knee flexed at 90º and the lumbar region in a neutral position. The goniometric platform was placed on the table in front of the participant. The therapist fixed the posterior superior iliac spines of the participant. And then participants were asked to hold the hands in front of the body (90° shoulder flexion) with a pen clamped between the hands. Participants were warned that the arms should follow the trunk rotation. Participants performed trunk rotation 3 times in the same direction and marked the point on the goniometric platform. The mean of the 3 measurements was calculated. The same protocol was repeated in the opposite direction.
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 21 Sep 2022.
- Background: PubMed 20801248Lee AS, Cholewicki J, Reeves NP, Zazulak BT, Mysliwiec LW. Comparison of trunk proprioception between patients with low back pain and healthy controls. Arch Phys Med Rehabil. 2010 Sep;91(9):1327-31. doi: 10.1016/j.apmr.2010.06.004.
- Background: PubMed 34025300Sarioglu K, Pekyavas NO. A Comparison Between People With and Without Subacromial Impingement Syndrome and a New Method for Measuring Thoracolumbar Fascia Flexibility. J Chiropr Med. 2021 Mar;20(1):9-15. doi: 10.1016/j.jcm.2021.01.003. Epub 2021 May 12.
- Background: PubMed 25642094Noh KH, Oh JS, Yoo WG. Comparison of lumbar repositioning error according to different lumbar angles in a flexion pattern (FP) subgroup of patients with non-specific chronic low back pain. J Phys Ther Sci. 2015 Jan;27(1):293-4. doi: 10.1589/jpts.27.293. Epub 2015 Jan 9.
- Background: PubMed 22164313Georgy EE. Lumbar repositioning accuracy as a measure of proprioception in patients with back dysfunction and healthy controls. Asian Spine J. 2011 Dec;5(4):201-7. doi: 10.4184/asj.2011.5.4.201. Epub 2011 Nov 28.
- 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.
Şule Şimşek, Phd principal investigator
PhD faculty member
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 Spinal Stenosis Lumbar, run by Pamukkale 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 6 inclusion and 1 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 21 Sep 2022. 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?
reposition error (time frame: september 2020-february 2021). The study lists 3 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 NCT05548608, which also lists 4 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 21 Sep 2022.