NCT07039214

Brief Summary

This study aimed to examine the associations between thoracolumbar fascia flexibility, trunk proprioception, and spinal posture in individuals experiencing non-specific low back pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2022

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 6, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2023

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

June 18, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 26, 2025

Completed
Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

7 months

First QC Date

June 18, 2025

Last Update Submit

June 25, 2025

Conditions

Keywords

ProprioceptionFascia

Outcome Measures

Primary Outcomes (1)

  • Thoracolumbar fascia flexibility

    The goniometric platform will be placed on a table in front of the participants to measure thoracolumbar flexibility (TLF). Participants will be seated on an unsupported chair with the lumbar region in a neutral position and the knees and hips flexed at 90°. The pelvis will be stabilized by the researcher holding the spina iliaca posterior superior. Participants will be instructed to rotate their trunk first to the right and then to the left, following verbal cues provided by the researcher. At the endpoint of each rotation, participants will be asked to mark the platform in front of them while maintaining 90° shoulder flexion, with their hands clasped in front of the trunk and holding a wooden pen between their hands. Each measurement will be performed three times for each side, and the average value will be recorded.

    baseline

Secondary Outcomes (5)

  • Proprioception Measurement

    baseline

  • Spinal Posture Assessment

    baseline

  • Visual Analog Scale

    baseline

  • Oswestry Low Back Pain Disability Questionnaire

    baseline

  • International Physical Activity Questionnaire - Short Form

    baseline

Study Arms (2)

Non-Specific low back pain group

Patients with non-Specific low back pain was included in this group.

Other: Observation of low-back pain symptoms

Asymptomatic group

Healthy people with no low back pain or any other symptom related to this region.

Other: Observation of healthy comparators

Interventions

No intervention was applied.

Non-Specific low back pain group

No intervention was applied.

Asymptomatic group

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with non-specific low back pain and healthy participants of same age were included in this study.

You may qualify if:

  • Willingness to voluntarily participate in the study
  • Age range between 35 and 65 years
  • Reporting a pain intensity in the lumbar region greater than 3 on the Visual Analog Scale (VAS)
  • Experiencing lumbar region pain for a duration of at least three months
  • Reporting pain intensity below 3 on the VAS in any other part of the body

You may not qualify if:

  • History of surgical intervention in the lumbar region
  • Being diagnosed with conditions such as osteoporosis, rheumatic diseases infection, fracture, structural deformity, cauda equina syndrome, tumor, radicular syndrome, or inflammatory disorders
  • Classification as "very active" based on the International Physical Activity Questionnaire (IPAQ) criteria
  • Hypermobility, defined as a Beighton Score of 4 or higher
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health Sciences Bolu Abant Izzet Baysal University

Bolu, Merkez, 14100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • ramazan kurul, Ph.D

    Abant Izzet Baysal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof

Study Record Dates

First Submitted

June 18, 2025

First Posted

June 26, 2025

Study Start

September 6, 2022

Primary Completion

April 1, 2023

Study Completion

April 15, 2023

Last Updated

June 29, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations