Relationship Between Low Back Pain and Sensitization

NCT06958263 | Completed

• 1 other identifier: Karabuk-003
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  Baseline

• Pain pressure threshold

  Pressure pain threshold will be measured with an algometer in kg. High values indicate a high pain threshold.

  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.

  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

  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

  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.

  Baseline

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic non-specific low back pain will be included in this study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karabuk University: lead

Study Sites (1)

Karabuk University, Physiotherapy and Rehabilitation Application and Research Center

Karabük, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 20036180 BACKGROUND

• 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.

  PMID: 34651401 RESULT

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Musa Güneş, PhD

  Karabuk University

  STUDY DIRECTOR

• Seher İmanur

  Karabuk University

  PRINCIPAL INVESTIGATOR

• Elif Aydoğan

  Karabuk University

  PRINCIPAL INVESTIGATOR

• Bedirhan Turan

  Karabuk University

  PRINCIPAL INVESTIGATOR

• Aydın Sinan Apaydın, PhD

  Karabuk University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PhD

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 6, 2025
• Study Start: May 8, 2025
• Primary Completion: December 30, 2025
• Study Completion: February 1, 2026
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)