NCT06537219

Brief Summary

This study aims to investigate the biomechanical parameters of thoracolumbar fascia (TLF) and pain-related properties including pain intensity, pressure pain threshold (ppt) and pain sensitivity in young adults with non-specific chronic low back pain (LBP), both those experiencing chronic low back pain (LBP) and without LBP.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

July 15, 2024

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 31, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 5, 2024

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2024

Completed
Last Updated

August 5, 2024

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

July 31, 2024

Last Update Submit

August 2, 2024

Conditions

Keywords

non-spesific back painthoracolumbar fasciastiffnesspain thresold

Outcome Measures

Primary Outcomes (3)

  • Numerical Pain Scale(NMS

    pain assessment

    1 month

  • Fascia stiffness

    thoracolumbar fascia stiffness assessment

    1month

  • the Pain Sensitivity Scale(PSS)

    Pain sensitivity assessment

    month

Study Arms (2)

back pain group

participants with chronic back pain( pain duration at least 3 months) aged between 18 and 50 years , male and female participanst will be included in the study. Those with orthopaedic, neurological and systemic diseases will be excluded from the study.

Other: Assessment

control group

healty male and female participants aged between 18 and 50 years

Other: Assessment

Interventions

Assessment of pain severity,pain thresold of the fascia, pain sensitivity

back pain groupcontrol group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Academic staff and university students at Atılım University will constitude the study population. Sample size is calculated with 85% power. 50 participants( 25 experiment,25 control group) will be included in the study

You may qualify if:

  • chronic back pain participants more than 3 months

You may not qualify if:

  • Those with orthopaedic, neurological and systemic diseases will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atılım University

Ankara, 06830, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

PainBack Pain

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Central Study Contacts

Naime Uluğ, PT,PhD

CONTACT

Süleyman Korkusuz, PT,PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
4 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 31, 2024

First Posted

August 5, 2024

Study Start

July 15, 2024

Primary Completion

August 30, 2024

Study Completion

September 15, 2024

Last Updated

August 5, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations