NCT05548608

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2021

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 21, 2022

Completed
Last Updated

September 21, 2022

Status Verified

September 1, 2022

Enrollment Period

2 months

First QC Date

September 15, 2022

Last Update Submit

September 19, 2022

Conditions

Spinal Stenosis Lumbar

Keywords

Lumbar spinal stenosisproprioceptionreposition error

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (3)

Group I (Healthy control)

Group I consists of patient relatives and patients who applied to the outpatient clinic for another ailment.

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.

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.

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.

Interventions

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.

Group I (Healthy control)Group II (chronic low back pain due to LSS )Group III (undergoing surgery due to LSS )

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Denizli State Hospital

Denizli, 09200, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 20801248BACKGROUND

  • 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.

    PMID: 34025300BACKGROUND

  • 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.

    PMID: 25642094BACKGROUND

  • 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.

    PMID: 22164313BACKGROUND

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Şule Şimşek, Phd

    PhD faculty member

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD faculty member

Study Record Dates

First Submitted

September 15, 2022

First Posted

September 21, 2022

Study Start

September 10, 2020

Primary Completion

November 10, 2020

Study Completion

February 10, 2021

Last Updated

September 21, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)