Lower Back Pain ChronicNSCLBP-AWARENCT07275255
Interoceptive Awareness, Physical Activity, Body Awareness and Emotional Status in Individuals With Non-Specific Chronic Low Back Pain
An observational study of Lower Back Pain Chronic and Non Specific Chronic Low Back Pain, run by Istinye University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lower Back Pain Chronic, Non Specific Chronic Low Back Pain
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official 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
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.
Read the 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.
- Keywords
- Interoceptive Awareness, Body Awareness, Non-specific Chronic Low Back Pain, Chronic Low Back Pain, Alexithymia, Physical Activity
- Medical subject headings
- Affective Symptoms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (3)
Body Awareness Score (BARQ-T)
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.
Measured: Baseline
Alexithymia Score (Toronto Alexithymia Scale-20)
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.
Measured: Baseline
Physical Activity Level (IPAQ-SF)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Back Pain ChronicStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gül Deniz Yılmaz Yelvar, Assoc. Prof., Study chair, Istinye University, Institute of Graduate Studies, Department of Physiotherapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07275255
- Sponsor's protocol ID
- ISTINYE-PT-NSCLBP-2025
- Acronym
- NSCLBP-AWARE
- Status last verified
- Nov 2025
- First submitted
- 28 Nov 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy and confidentiality considerations.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07275255
- Acronym / sponsor ID
- NSCLBP-AWARE / ISTINYE-PT-NSCLBP-2025
- Keywords
- Interoceptive Awareness, Body Awareness, Non-specific Chronic Low Back Pain, Chronic Low Back Pain, Alexithymia, Physical Activity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 10 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Body Awareness Score (BARQ-T)
Time frame: Baseline
Alexithymia Score (Toronto Alexithymia Scale-20)
Time frame: Baseline
Physical Activity Level (IPAQ-SF)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy and confidentiality considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gül Deniz Yılmaz Yelvar, Assoc. Prof. study chair
Istinye University, Institute of Graduate Studies, Department of Physiotherapy and Rehabilitation
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Back Pain Chronic and Non Specific Chronic Low Back Pain, run by Istinye University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interoceptive Awareness Score (MAIA/MAIA-2) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.