Lumbar Proprioception in Patients With Lumbar Spinal Stenosis

Spinal Stenosis Lumbar Clinical Trial

Official title:

Effect of Different Injury Mechanism on Lumbar Proprioception in Patients With Lumbar Spinal Stenosis: an Observational Healthy Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05548608
• Other study ID #: 28.07.2020/14
• Status: Completed
• Start date: September 10, 2020
• Est. completion date: February 10, 2021

Study information

• Verified date: September 2022
• Source: Pamukkale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 10, 2021
• Est. primary completion date: November 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Spinal Stenosis
• Spinal Stenosis Lumbar

Intervention

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.
Target positions of reposition error were: 30º forward bending and 15º backward bending in sitting and standing.

Locations

Country	Name	City	State
Turkey	Denizli State Hospital	Denizli

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	september 2020-february 2021
Primary	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)	september 2020-february 2021
Primary	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.	september 2020-february 2021