Interoceptive Awareness, Physical Activity, Body Awareness and Emotional Status in Individuals With Non-Specific Chronic Low Back Pain (NSCLBP-AWARE)

December 15, 2025 updated by: Istinye University

Non-Specific Chronic Low Back Pain: Investigation of Interoceptive Awareness, Physical Activity Level, Body Awareness and Emotional Status in Individuals With Non-Specific Chronic Low Back Pain

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.

Study Overview

Status

Not yet recruiting

Detailed Description

This study is designed as a quantitative, cross-sectional, observational investigation involving adults aged 18-65 years diagnosed with non-specific chronic low back pain (ns-cLBP). Non-specific chronic low back pain is defined as lumbar pain lasting at least three months without an identifiable structural pathology such as tumor, infection, fracture, inflammatory disease, spinal stenosis, or radiculopathy. Chronic low back pain is known to negatively affect daily activities, emotional well-being, physical function, and quality of life. Recent literature suggests that interoceptive awareness, emotional regulation, body awareness, and physical activity level play important roles in the pain experience and coping mechanisms of individuals with chronic pain.

Despite growing evidence, the multidimensional relationships among interoceptive awareness, body awareness, physical activity level, emotional status, and pain severity have not been comprehensively examined in individuals with non-specific chronic low back pain. Therefore, this study aims to fill this gap by evaluating these variables together.

A total of approximately 130 participants will be recruited. Sociodemographic and clinical data including age, gender, marital status, education level, duration of pain, medication use, smoking status, height, weight, BMI, and waist-to-hip ratio will be recorded. The following validated self-report questionnaires will be administered:

Interoceptive awareness: Multidimensional Assessment of Interoceptive Awareness (MAIA/MAIA-2)

Body awareness: Body Awareness Rating Questionnaire - Turkish (BARQ-T)

Emotional status (alexithymia): Toronto Alexithymia Scale-20 (TAS-20)

Pain intensity: Visual Analog Scale (VAS)

Physical activity level: International Physical Activity Questionnaire - Short Form (IPAQ-SF)

Data analysis will be performed using SPSS (v.27). Normality will be assessed with the Shapiro-Wilk test. Parametric or non-parametric correlation tests (Pearson or Spearman) will be used to examine relationships between variables. Group comparisons (e.g., sex, age groups, physical activity levels) will be conducted using independent samples t-tests or Mann-Whitney U tests depending on data distribution. Statistical significance will be set at p < 0.05.

The study is expected to contribute new insights into the emotional, cognitive, and sensory mechanisms underlying chronic low back pain. Understanding these multidimensional interactions may help clinicians develop more targeted and individualized rehabilitation strategies, particularly those incorporating body awareness and interoception-based therapeutic approaches.

Study Type

Observational

Enrollment (Estimated)

130

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interoceptive Awareness Score (MAIA/MAIA-2)
Time Frame: Baseline
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Awareness Score (BARQ-T)
Time Frame: Baseline
Body awareness will be measured using the Body Awareness Rating Questionnaire - Turkish (BARQ-T). The scale assesses perception of bodily sensations and awareness-related behaviors. Higher scores indicate greater body awareness.
Baseline
Alexithymia Score (Toronto Alexithymia Scale-20)
Time Frame: Baseline
Emotional status will be assessed using the Toronto Alexithymia Scale-20 (TAS-20), a 20-item questionnaire measuring difficulty identifying feelings, difficulty describing feelings, and externally oriented thinking. Higher scores represent higher levels of alexithymia.
Baseline
Physical Activity Level (IPAQ-SF)
Time Frame: Baseline
Physical activity will be assessed using the International Physical Activity Questionnaire - Short Form (IPAQ-SF). Total activity will be calculated in MET-minutes/week, and participants will be categorized as low, moderate, or high activity level.
Baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity Score (Visual Analog Scale)
Time Frame: Baseline
Pain intensity will be measured using a 10-cm Visual Analog Scale (VAS), where 0 represents "no pain" and 10 represents "worst imaginable pain." Scores are recorded in millimeters.
Baseline

Collaborators and Investigators

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

Investigators

  • Study Chair: Gül Deniz Yılmaz Yelvar, Assoc. Prof., Istinye University, Institute of Graduate Studies, Department of Physiotherapy and Rehabilitation

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 (Estimated)

January 1, 2026

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

November 28, 2025

First Submitted That Met QC Criteria

November 28, 2025

First Posted (Estimated)

December 10, 2025

Study Record Updates

Last Update Posted (Actual)

December 16, 2025

Last Update Submitted That Met QC Criteria

December 15, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

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.

Clinical Trials on Non Specific Chronic Low Back Pain

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