- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06958263
- Original Trial
Relationship Between Low Back Pain and Sensitization
May 12, 2026 updated by: Musa Güneş, Karabuk University
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
103
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Karabük, Turkey (Türkiye)
- Karabuk University, Physiotherapy and Rehabilitation Application and Research Center
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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
N/A
Sampling Method
Non-Probability Sample
Study Population
Patients with chronic non-specific low back pain will be included in this study.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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 |
|---|
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Higher sensitization
Patients with chronic non-specific low back pain with high sensitization will be included.
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Normal sensitization
Patients with chronic non-specific low back pain with normal sensitization will be included.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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Baseline
|
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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.
|
Baseline
|
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Pain pressure threshold
Time Frame: Baseline
|
Pressure pain threshold will be measured with an algometer in kg.
High values indicate a high pain threshold.
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Baseline
|
|
Disability levels
Time Frame: Baseline
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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.
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Baseline
|
|
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
|
Baseline
|
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Low back awereness
Time Frame: Baseline
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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
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Baseline
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Trunk muscle endurance
Time Frame: Baseline
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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.
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Baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Musa Güneş, PhD, Karabuk University
- Principal Investigator: Aydın Sinan Apaydın, PhD, Karabuk University
- Principal Investigator: Seher İmanur, Karabuk University
- Principal Investigator: Elif Aydoğan, Karabuk University
- Principal Investigator: Bedirhan Turan, Karabuk University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Colgan 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.
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 (Actual)
May 8, 2025
Primary Completion (Actual)
December 30, 2025
Study Completion (Actual)
February 1, 2026
Study Registration Dates
First Submitted
April 25, 2025
First Submitted That Met QC Criteria
April 25, 2025
First Posted (Actual)
May 6, 2025
Study Record Updates
Last Update Posted (Actual)
May 14, 2026
Last Update Submitted That Met QC Criteria
May 12, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Karabuk-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
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