Lumbar Proprioception in Patients With Lumbar Spinal Stenosis

September 19, 2022 updated by: Şule ŞİMŞEK, Pamukkale University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Denizli, Turkey, 09200
        • Denizli State Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Target positions of reposition error were: 30º forward bending and 15º backward bending in sitting and standing.
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.
Target positions of reposition error were: 30º forward bending and 15º backward bending in sitting and standing.
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.
Target positions of reposition error were: 30º forward bending and 15º backward bending in sitting and standing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
september 2020-february 2021
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)
september 2020-february 2021
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.
september 2020-february 2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pamukkale University

Investigators

  • Principal Investigator: Şule Şimşek, Phd, Phd faculty member

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2020

Primary Completion (Actual)

November 10, 2020

Study Completion (Actual)

February 10, 2021

Study Registration Dates

First Submitted

September 15, 2022

First Submitted That Met QC Criteria

September 19, 2022

First Posted (Actual)

September 21, 2022

Study Record Updates

Last Update Posted (Actual)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 19, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 28.07.2020/14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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