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NCT Number: NCT07275255

Interoceptive Awareness, Physical Activity, 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Istinye University

Other

Registry information

Official study title

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

Acronym: NSCLBP-AWARE

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 10, 2025
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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