Low Back PainNCT06958263
Relationship Between Low Back Pain and Sensitization
An observational study of Low Back Pain, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial summary
Chronic non-specific low back pain is a common health problem that significantly affects the quality of life of individuals. Increased pain intensity leads to deficiencies in the body's sensory organization, resulting in decreased awareness. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- How many people
- 103 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 May 2025to 1 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: Patients with chronic non-specific low back pain will be included in this study.
Who may be able to join
- Being between the ages of 18-65
- Being diagnosed with chronic non-specific low back pain (Pain between the gluteal folds and the 12th ribs that lasts at least 12 weeks and has no known pathoanatomical cause)
- Being willing to participate in the study
Who cannot join
- Having a psychological disorder, mental disorder, cancer and severe depression
- Having a history of primary or metastatic spinal malignancy, spinal fracture
- Having a neurological disease (Hemiplegia, Multiple Sclerosis, Parkinson's, etc.)
- Being diagnosed with advanced osteoporosis
- Having a history of surgery or acute infection in the lumbar region
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karabuk University, Physiotherapy and Rehabilitation Application and Research Center
Karabük
About this study
Official title: Factors Associated With Sensitization in Patients With Chronic Low Back Pain
Chronic non-specific low back pain is a common health problem that significantly affects the quality of life of individuals. Increased pain intensity leads to deficiencies in the body's sensory organization, resulting in decreased awareness. This can lead to dysfunction in body awareness, which is known as the ability of individuals to perceive the sensations and conditions of their bodies. Body awareness plays a critical role in pain management and mobility. Chronic pain causes constant stimulation in the nervous system, causing central sensitization, which is when the central nervous system becomes overly sensitive to pain signals. As a result, a decrease in the pain threshold, constant pain, and increased muscle tension occur. Increased pain intensity and decreased awareness can result in a decrease in the maintenance of optimal functions, affecting muscular endurance. Inadequate muscular endurance can increase low back pain and make it difficult for individuals to perform their daily activities. Therefore, this study aims to examine the relationship between body awareness, central sensitization, disability, and muscular endurance in patients with chronic non-specific low back pain.
Read the detailed description
Body awareness plays a critical role in pain management and mobility. Individuals with high body awareness can better manage their pain, which can contribute to a decrease in disability levels. Chronic pain causes constant stimulation in the nervous system, which causes central sensitization, which is when the central nervous system becomes oversensitive to pain signals. As a result, a decrease in the pain threshold, constant pain, and increased muscle tension occur. In addition, central sensitization can cause the body to be more vulnerable to injuries due to the body being in an overstimulated state. Increased pain intensity and decreased awareness can result in a decrease in the maintenance of optimal functions, affecting muscular endurance. Inadequate muscular endurance can increase low back pain and make it difficult for individuals to perform their daily activities. The literature has attempted to emphasize the relationship between pain, disability, and body awareness in various populations. However, the relationship between body awareness and central sensitization has not been sufficiently studied. Sensitization in the body as a result of central sensitization may be associated with changes in awareness. Understanding these complex relationships is important for developing appropriate treatment strategies in the rehabilitation and clinical follow-up process. Therefore, this study aims to investigate the relationship between body awareness, central sensitization, disability and muscular endurance in patients with chronic non-specific low back pain. Patients with chronic non-specific low back pain will be included in the study. Body awareness, central sensitization, pain intensity, muscular endurance and disability levels of the patients will be evaluated. The data obtained from the study will be analyzed appropriately.
- Conditions
- Low Back Pain
- Medical subject headings
- Low Back Pain
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 |
|---|---|---|
| Higher sensitization | Patients with chronic non-specific low back pain with high sensitization will be included. | |
| Normal sensitization | Patients with chronic non-specific low back pain with normal sensitization will be included. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central sensitization
Central sensitization will be assessed with the "Central Sensitization Scale". The total score range is between 0-100 points. As the score increases, sensitization increases and 40 points and above are considered higher sensitization.
Measured: Baseline
Pain severity
Pain intensity will be assessed with Vizüel Analog Scale (VAS). VAS varies between 0-10 and the higher the score, the greater the pain.
Measured: Baseline
Pain pressure threshold
Pressure pain threshold will be measured with an algometer in kg. High values indicate a high pain threshold.
Measured: Baseline
Disability levels
Disability will be measured by the Oswestry Disability Index. The total score ranges from 0-100 and the higher the score, the higher the level of disability.
Measured: Baseline
Body awereness
It will be measured with a body awareness survey. The total score varies between 18-126 and as the score increases, awareness increases
Measured: Baseline
Low back awereness
It will be measured with the Fremantle Waist Awareness Questionnaire (FBFA). The total score varies between 0-36 and the awareness decreases as the score increases
Measured: Baseline
Trunk muscle endurance
The Stabilizer Pressure Biofeedback Unit will be used to evaluate the multifidus muscle endurance. The time maintained at 40 mmHg pressure will be recorded. As the time increases, the endurance increases.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start8 May 2025
- Primary completion30 Dec 2025
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Musa Güneş, Karabuk University
- Investigators
- Musa Güneş, PhD, Study director, Karabuk UniversitySeher İmanur, Principal investigator, Karabuk UniversityElif Aydoğan, Principal investigator, Karabuk UniversityBedirhan Turan, Principal investigator, Karabuk UniversityAydın Sinan Apaydın, PhD, Principal investigator, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958263
- Sponsor's protocol ID
- Karabuk-003
- Status last verified
- May 2026
- First submitted
- 25 Apr 2025
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nijs J, Van Houdenhove B, Oostendorp RA. Recognition of central sensitization in patients with musculoskeletal pain: Application of pain neurophysiology in manual therapy practice. Man Ther. 2010 Apr;15(2):135-41. doi: 10.1016/j.math.2009.12.001. Epub 2009 Dec 24.
PubMed 20036180Colgan DD, Eddy A, Green K, Oken B. Adaptive body awareness predicts fewer central sensitization-related symptoms and explains relationship between central sensitization-related symptoms and pain intensity: A cross-sectional study among individuals with chronic pain. Pain Pract. 2022 Feb;22(2):222-232. doi: 10.1111/papr.13083. Epub 2021 Nov 11.
PubMed 34651401Gunes M, Imanur S, Aydogan E, Turan B, Apaydin AS. The relationship between central sensitization, body awareness, pain, and muscle endurance in patients with chronic nonspecific low back pain. Physiother Theory Pract. 2026 May 17:1-10. doi: 10.1080/09593985.2026.2674078. Online ahead of print.
PubMed 42144681
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Sensitization in Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT06958263
- Acronym / sponsor ID
- Karabuk-003
- Conditions
- Low Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 8 May 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 6 May 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.
Chronic non-specific low back pain is a common health problem that significantly affects the quality of life of individuals. Increased pain intensity leads to deficiencies in the body's sensory organization, resulting in decreased awareness. This can lead to dysfunction in body awareness, which is known as the ability of individuals to perceive the sensations and conditions of their bodies. Body awareness plays a critical role in pain management and mobility. Chronic pain causes constant stimulation in the nervous system, causing central sensitization, which is when the central nervous system becomes overly sensitive to pain signals. As a result, a decrease in the pain threshold, constant pain, and increased muscle tension occur. Increased pain intensity and decreased awareness can result in a decrease in the maintenance of optimal functions, affecting muscular endurance. Inadequate muscular endurance can increase low back pain and make it difficult for individuals to perform their daily activities. Therefore, this study aims to examine the relationship between body awareness, central sensitization, disability, and muscular endurance in patients with chronic non-specific low back pain.
Detailed description
Body awareness plays a critical role in pain management and mobility. Individuals with high body awareness can better manage their pain, which can contribute to a decrease in disability levels. Chronic pain causes constant stimulation in the nervous system, which causes central sensitization, which is when the central nervous system becomes oversensitive to pain signals. As a result, a decrease in the pain threshold, constant pain, and increased muscle tension occur. In addition, central sensitization can cause the body to be more vulnerable to injuries due to the body being in an overstimulated state. Increased pain intensity and decreased awareness can result in a decrease in the maintenance of optimal functions, affecting muscular endurance. Inadequate muscular endurance can increase low back pain and make it difficult for individuals to perform their daily activities. The literature has attempted to emphasize the relationship between pain, disability, and body awareness in various populations. However, the relationship between body awareness and central sensitization has not been sufficiently studied. Sensitization in the body as a result of central sensitization may be associated with changes in awareness. Understanding these complex relationships is important for developing appropriate treatment strategies in the rehabilitation and clinical follow-up process. Therefore, this study aims to investigate the relationship between body awareness, central sensitization, disability and muscular endurance in patients with chronic non-specific low back pain. Patients with chronic non-specific low back pain will be included in the study. Body awareness, central sensitization, pain intensity, muscular endurance and disability levels of the patients will be evaluated. The data obtained from the study will be analyzed appropriately.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Higher sensitization | – | –Patients with chronic non-specific low back pain with high sensitization will be included. |
| Normal sensitization | – | –Patients with chronic non-specific low back pain with normal sensitization will be included. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic non-specific low back pain will be included in this study.
Key inclusion criteria (3 listed)
- Being between the ages of 18-65
- Being diagnosed with chronic non-specific low back pain (Pain between the gluteal folds and the 12th ribs that lasts at least 12 weeks and has no known pathoanatomical cause)
- Being willing to participate in the study
Key exclusion criteria (5 listed)
- Having a psychological disorder, mental disorder, cancer and severe depression
- Having a history of primary or metastatic spinal malignancy, spinal fracture
- Having a neurological disease (Hemiplegia, Multiple Sclerosis, Parkinson's, etc.)
- Being diagnosed with advanced osteoporosis
- Having a history of surgery or acute infection in the lumbar region
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
Central sensitization
Time frame: Baseline
Central sensitization will be assessed with the "Central Sensitization Scale". The total score range is between 0-100 points. As the score increases, sensitization increases and 40 points and above are considered higher sensitization.
Pain severity
Time frame: Baseline
Pain intensity will be assessed with Vizüel Analog Scale (VAS). VAS varies between 0-10 and the higher the score, the greater the pain.
Pain pressure threshold
Time frame: Baseline
Pressure pain threshold will be measured with an algometer in kg. High values indicate a high pain threshold.
Disability levels
Time frame: Baseline
Disability will be measured by the Oswestry Disability Index. The total score ranges from 0-100 and the higher the score, the higher the level of disability.
Body awereness
Time frame: Baseline
It will be measured with a body awareness survey. The total score varies between 18-126 and as the score increases, awareness increases
Low back awereness
Time frame: Baseline
It will be measured with the Fremantle Waist Awareness Questionnaire (FBFA). The total score varies between 0-36 and the awareness decreases as the score increases
Trunk muscle endurance
Time frame: Baseline
The Stabilizer Pressure Biofeedback Unit will be used to evaluate the multifidus muscle endurance. The time maintained at 40 mmHg pressure will be recorded. As the time increases, the endurance increases.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Background: PubMed 20036180Nijs J, Van Houdenhove B, Oostendorp RA. Recognition of central sensitization in patients with musculoskeletal pain: Application of pain neurophysiology in manual therapy practice. Man Ther. 2010 Apr;15(2):135-41. doi: 10.1016/j.math.2009.12.001. Epub 2009 Dec 24.
- Results publication: PubMed 34651401Colgan DD, Eddy A, Green K, Oken B. Adaptive body awareness predicts fewer central sensitization-related symptoms and explains relationship between central sensitization-related symptoms and pain intensity: A cross-sectional study among individuals with chronic pain. Pain Pract. 2022 Feb;22(2):222-232. doi: 10.1111/papr.13083. Epub 2021 Nov 11.
- Derived from this study: PubMed 42144681Gunes M, Imanur S, Aydogan E, Turan B, Apaydin AS. The relationship between central sensitization, body awareness, pain, and muscle endurance in patients with chronic nonspecific low back pain. Physiother Theory Pract. 2026 May 17:1-10. doi: 10.1080/09593985.2026.2674078. Online ahead of print.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Musa Güneş, PhD study director
Karabuk University
Seher İmanur principal investigator
Karabuk University
Elif Aydoğan principal investigator
Karabuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Karabuk University at 1 site in Turkey (Türkiye).
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 3 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: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Central sensitization (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06958263, which also lists 3 linked publications.
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 14 May 2026; AzTrials last refreshed its copy on 29 Oct 2026.