Clinical trial NCT05548608: Lumbar Proprioception in Patients With Lumbar Spinal Stenosis
Official title: Effect of Different Injury Mechanism on Lumbar Proprioception in Patients With Lumbar Spinal Stenosis: an Observational Healthy Controlled Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Stenosis Lumbar
Keywords: Lumbar spinal stenosis
proprioception
reposition error
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

.having any previous inner ear inflammation or vestibular disorders .having diabetes and being pregnant.

Primary outcomes:
measure: reposition error
timeFrame: september 2020-february 2021
measure: pain intensity
timeFrame: september 2020-february 2021
measure: flexibility of the TLF
timeFrame: september 2020-february 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Denizli State Hospital
Study officials:
affiliation: PhD faculty member
name: Şule Şimşek, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Sarioglu 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.
citation: Noh 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.
citation: Georgy 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.