Lumbar Spinal Stenosis and Central Sensitization

NCT07001982 | Completed

• 1 other identifier: Karabuk-2325
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

Lumbar spinal stenosis (LSS) functionally limits individuals by causing pain in both the waist and the legs during activity and walking. Pain is, therefore, an important problem for patients. Pain lasts for years in LSS and thus becomes chronically persistent. As a result, persistent pain can cause sensitization due to a decrease in the pain threshold. This condition affects patients not only biomedically but also biopsychosocially. For this reason, various sleep disorders and mood disorders can develop in patients. Therefore, this study aimed to examine the relationship between central sensitization and pain, disability, sleep and depression in patients with LSS.

Conditions

Lumbar Spinal Stenosis

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 Numeric Rating Scale (NRS). NRS 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

• Pain catastrophizing

  It will be evaluated using the pain catastrophizing scale. The total score varies between 0-52. As the score increases, negative feelings and thoughts increase.

  Baseline

• Sleep quality

  Sleep quality will be assessed with the Pittsburgh Sleep Quality Index. It is scored from 0 to 21, with higher scores indicating worse sleep quality.

  Baseline

• Depression

  The Center for Epidemiological Studies Depression Scale (CES-D) will be used to assess depression.The total score is 0-60. As the score increases, depression increases.

  Baseline

Study Arms (2)

Patients with central sensitization with LSS

Patients with lumbar spinal stenosis with high sensitization will be included.

Normal sensitization patients with LSS

Patients with lumbar spinal stenosis with normal sensitization will be included.

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with lumbar spinal stenosis will be included in this study.

You may qualify if:

• Diagnosed with lumbar spinal stenosis by MRI,
• The ages of 45-80,
• Low back and/or leg pain that has persisted for at least 3 months
• Volunteer to participate in the study

You may not qualify if:

• Patients who did not agree to participate in the study,
• Those with a history of serious neurological diseases such as Parkinson's, hemiplegia, multiple sclerosis,
• Those who had undergone surgery in the lumbar region within the last year,
• Those with advanced joint disease in the lower extremity,
• Those with malignancy in the spine,
• Those who had a previous operation for the lower extremity,
• Those who had a pain or disability in other musculoskeletal joints,
• Those who had a psychological disorder or peripheral vascular disease
• Those who had any concurrent serious medical condition, including sepsis or cancer
• Those who did not cooperate well were not included in the study.

Sponsors & Collaborators

• Karabuk University: lead

Study Sites (1)

Karabuk University

Karabük, 78000, Turkey (Türkiye)

Location

Related Publications (2)

• Iwasaki R, Miki T, Miyazaki M, Kanetaka C, Mitsuyama T, Ota K. Neuropathic Pain Was Associated with Central Sensitivity Syndrome in Patients with Preoperative Lumbar Spinal Stenosis Using the painDETECT and Central Sensitization Inventory Questionnaires: A Cross-Sectional Study. Pain Res Manag. 2023 May 10;2023:9963627. doi: 10.1155/2023/9963627. eCollection 2023.

  PMID: 37207128 RESULT

• Ogon I, Takashima H, Morita T, Fukushi R, Takebayashi T, Teramoto A. Association of central sensitization, visceral fat, and surgical outcomes in lumbar spinal stenosis. J Orthop Surg Res. 2023 Nov 21;18(1):886. doi: 10.1186/s13018-023-04376-2.

  PMID: 37990264 RESULT

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Musa Güneş, PhD

  Karabuk University

  STUDY DIRECTOR

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: May 23, 2025
• First Posted: June 3, 2025
• Study Start: June 17, 2025
• Primary Completion: October 15, 2025
• Study Completion: October 15, 2025
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)