Clinical trial NCT06958263: Relationship Between Low Back Pain and Sensitization
Official title: Factors Associated With Sensitization in Patients With Chronic Low Back Pain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Low Back Pain
Lead sponsor: Karabuk University
Sponsor class: OTHER
First posted: 2025-05-06
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic non-specific low back pain will be included in this study.

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Central sensitization
timeFrame: Baseline
measure: Pain severity
timeFrame: Baseline
measure: Pain pressure threshold
timeFrame: Baseline
measure: Disability levels
timeFrame: Baseline
measure: Body awereness
timeFrame: Baseline
measure: Low back awereness
timeFrame: Baseline
measure: Trunk muscle endurance
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Karabük
country: Turkey
facility: Karabuk University, Physiotherapy and Rehabilitation Application and Research Center
Study officials:
affiliation: Karabuk University
name: Musa Güneş, PhD
role: STUDY_DIRECTOR
affiliation: Karabuk University
name: Seher İmanur
role: PRINCIPAL_INVESTIGATOR
affiliation: Karabuk University
name: Elif Aydoğan
role: PRINCIPAL_INVESTIGATOR
affiliation: Karabuk University
name: Bedirhan Turan
role: PRINCIPAL_INVESTIGATOR
affiliation: Karabuk University
name: Aydın Sinan Apaydın, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.