Lumbar Spinal Stenosis and Central Sensitization

Recruiting

• Conditions: Lumbar Spinal Stenosis

• Registration Number: NCT07001982
• Lead Sponsor: Karabuk University

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 therefore becomes chronically persistent. As a result, persistent pain can cause sensitization as a result of 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.

Detailed Description

Lumbar spinal stenosis (LSS) functionally limits individuals by causing pain in both the waist and the legs during activity and walking. In particular, the pain in LSS lasts for years and becomes chronic and can cause persistent and disturbing sensitization. This situation may be associated with a decrease in the pain threshold and allodynia. Various studies show that the sensitization that occurs can affect individuals biomedically and may lead to important health problems. Some of these are sleep and depression problems. Sleep and healthy mentality are important for the continuation of daily activities and the preservation of quality of life. However, when the literature is examined, it is seen that central sensitization and the parameters that may be related to this have not been examined sufficiently. Therefore, the aim of this study is to examine the relationship between central sensitization and pain, disability, sleep and depression in patients with LSS.

Study Timeline

• Status Verified: 2025-05
• Study Start: 2025-05-23
• Study First Submitted: 2025-05-23
• Study First Submitted QC: 2025-05-23
• Last Update Submitted: 2025-05-23
• Study First Posted: 2025-06-03
• Last Update Posted: 2025-06-03
• Primary Completion: 2025-10-15
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Dagnosed with lumbar spinal stenosis by MRI,
• The ages of 45-80,
• Patients who can walk and stand on their own or with an assistive device,
• Volunteer to participate in the study

Exclusion Criteria

• 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 serious lung and cardiovascular disease,
• 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 with vision and/or vestibular system problems,
• Those who did not cooperate well were not included in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disability levels	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.
Pain catastrophizing	Baseline	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.
Sleep quality	Baseline	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.
Depression	Baseline	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.
Central sensitization	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	Baseline	Pain intensity will be assessed with Numeric Rating Scale (NRS). NRS varies between 0-10 and the higher the score, the greater the pain.
Pain pressure threshold	Baseline	Pressure pain threshold will be measured with an algometer in kg. High values indicate a high pain threshold.

Trial Locations

Locations (1)

Karabuk University; 🇹🇷 Karabük, Turkey