NCT07275255

Brief Summary

This observational cross-sectional study aims to examine the relationships between interoceptive awareness, physical activity level, body awareness, emotional status, and pain intensity in individuals with non-specific chronic low back pain. Non-specific chronic low back pain refers to pain in the lumbar region lasting for at least three months without an identifiable structural or pathological cause. Participants aged 18-65 years who meet the diagnostic criteria for non-specific chronic low back pain will be evaluated using validated self-report questionnaires. These include measures of interoceptive awareness, body awareness, alexithymia, physical activity level, and pain intensity. Sociodemographic and clinical characteristics such as age, gender, education level, duration of pain, medication use, height, weight, and BMI will also be collected. The purpose of the study is to better understand how internal body perception, physical activity, emotional processing, and body awareness interact with pain experience in this population. Findings may contribute to the development of individualized rehabilitation programs and inform clinicians about the multidimensional factors influencing chronic low back pain.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
4mo left

Started Jan 2026

Shorter than P25 for all trials

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress52%
Jan 2026Sep 2026

First Submitted

Initial submission to the registry

November 28, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 10, 2025

Completed
22 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

December 16, 2025

Status Verified

November 1, 2025

Enrollment Period

2 months

First QC Date

November 28, 2025

Last Update Submit

December 15, 2025

Conditions

Keywords

Interoceptive AwarenessBody AwarenessNon-specific Chronic Low Back PainChronic Low Back PainAlexithymiaPhysical Activity

Outcome Measures

Primary Outcomes (1)

  • Interoceptive Awareness Score (MAIA/MAIA-2)

    Interoceptive awareness will be assessed using the Multidimensional Assessment of Interoceptive Awareness (MAIA/MAIA-2). The scale consists of 37 items rated on a 5-point Likert scale, yielding scores for eight subscales. Higher scores indicate greater interoceptive awareness.

    Baseline

Secondary Outcomes (3)

  • Body Awareness Score (BARQ-T)

    Baseline

  • Alexithymia Score (Toronto Alexithymia Scale-20)

    Baseline

  • Physical Activity Level (IPAQ-SF)

    Baseline

Other Outcomes (1)

  • Pain Intensity Score (Visual Analog Scale)

    Baseline

Study Arms (1)

Non-specific Chronic Low Back Pain Group

A cohort of adults aged 18-65 diagnosed with non-specific chronic low back pain. Participants will complete validated self-report questionnaires assessing interoceptive awareness, body awareness, emotional status, physical activity level, and pain intensity.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults aged 18-65 years diagnosed with non-specific chronic low back pain for at least 3 months. Participants will be recruited from the physiotherapy and rehabilitation outpatient clinic (Fizyotem) at Istinye University. Individuals must be able to understand and complete self-report questionnaires. A total of approximately 130 participants are expected to be enrolled.

You may qualify if:

  • Adults aged 18-65 years.
  • Diagnosed with non-specific chronic low back pain.
  • Duration of pain ≥ 3 months.
  • Self-reported average pain score ≥ 4/10 on the Visual Analog Scale.
  • Ability to understand and complete self-report questionnaires.

You may not qualify if:

  • Low back pain due to specific pathologies (e.g., tumor, infection, fracture, inflammatory disease).
  • Serious systemic, neurological, or psychiatric comorbidities.
  • History of spinal surgery within the past year.
  • Pregnancy.
  • Language or cognitive impairments preventing questionnaire completion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Affective SymptomsMotor Activity

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Gül Deniz Yılmaz Yelvar, Assoc. Prof.

    Istinye University, Institute of Graduate Studies, Department of Physiotherapy and Rehabilitation

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2025

First Posted

December 10, 2025

Study Start

January 1, 2026

Primary Completion

March 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

December 16, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to privacy and confidentiality considerations.