NCT05741645

Brief Summary

Low back pain is a common health problem worldwide. Epidemiological studies have shown that 70-80% of all people are affected at least once in their lifetime. Although it is common, often the cause of the pain has not been determined and is called 'nonspecific low back pain. Chronic low back pain ranks second among the most common pain complaints under the age of 45 in the industrial age of limited activity. Organic pathology is not encountered in most musculoskeletal system pains. There are usually many underlying causes. The current literature offers a variety of treatment options, depending on the duration and severity of the symptoms of non-specific low back pain. These treatments include behavioral cognitive therapy, medication, electrophysical agents, manual therapy, and general exercises. Looking at the literature, it has been observed that there are not many objective studies investigating the effect of elastic bandage application on muscle elasticity. 'Shear Wave Elastography' is a method that quantitatively reveals the elasticity of tissues by measuring the speed of shear waves formed in the tissues through non-invasive high-frequency ultrasound waves. In recent studies, Shear Wave Elastography has shown promising results in demonstrating the elasticity of peripheral nerves.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Jun 2023

Typical duration for not_applicable low-back-pain

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

First Submitted

Initial submission to the registry

February 14, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 23, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

June 20, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2024

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

April 15, 2025

Status Verified

April 1, 2025

Enrollment Period

1 year

First QC Date

February 14, 2023

Last Update Submit

April 14, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • muscle stiffness

    The muscle stiffness of lumbar back muscles will be assessed using the B-mode of the ultrasound Shear Wave Elastography (SWE) imaging device. Longitudinal ultrasound Shear Wave Elastography images of the multifidus and erector spinal muscles will be taken bilaterally with a linear array probe in the prone position.

    4 weeks

Secondary Outcomes (7)

  • The sit and reach test

    4 weeks

  • The functional reach test

    4 weeks

  • Lateral bridge test

    4 weeks

  • The Flamingo Test

    4 weeks

  • Back isometric endurance test

    4 weeks

  • +2 more secondary outcomes

Study Arms (2)

Study group

EXPERIMENTAL

Study group consists of 15 participants, where the elastic kinesiotaping is applied and evaluations are made before and after.

Other: Kinesiotaping

Control Group

SHAM COMPARATOR

To the participants in the control group, the elastic taping will be randomly applied to a place outside the area to be measured, without stretching, and without causing any effect.

Other: Sham Kinesiotaping

Interventions

During the kinesio taping of the erector spina vs multifidus muscles, the patient is in a standing position. Kinesiotape is applied with 50% tension and stays in the patient for 30 minutes.

Study group

The elastic taping will be randomly applied to a place outside the area to be measured, without stretching, and without causing any effect.

Control Group

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • patients who diagnosed with non-specific low back pain
  • between the ages of 18-24
  • patients who able to perform at least 40° of trunk flexion

You may not qualify if:

  • patients who obese, pregnant, had specific low back pain
  • indication for surgery in the past 1 year
  • the trauma of lumbar region, and systemic inflammatory disease affecting this area
  • exercise and conventional physiotherapy in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istinye University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

February 14, 2023

First Posted

February 23, 2023

Study Start

June 20, 2023

Primary Completion

June 20, 2024

Study Completion

April 1, 2025

Last Updated

April 15, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations