Clinical trial NCT07001982: Lumbar Spinal Stenosis and Central Sensitization
Official title: The Relationship Central Sensitization, Pain and Depression Patients With Lumbar Spinal Stenosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lumbar Spinal Stenosis
Lead sponsor: Karabuk University
Sponsor class: OTHER
First posted: 2025-06-03
Enrollment: 68
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with lumbar spinal stenosis will be included in this study.

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.

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 decreased pain threshold and allodynia. Various studies show that sensitization can affect individuals biomedically and may lead to important health problems. Some of these are sleep and depression problems. Sleep and a healthy mentality are important for continuing daily activities and preserving 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.

Eligibility criteria: Inclusion Criteria:

* 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

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 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.

Primary outcomes:
measure: Central sensitization
timeFrame: Baseline
measure: Pain severity
timeFrame: Baseline
measure: Pain pressure threshold
timeFrame: Baseline
measure: Disability levels
timeFrame: Baseline
measure: Pain catastrophizing
timeFrame: Baseline
measure: Sleep quality
timeFrame: Baseline
measure: Depression
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Karabük
country: Turkey
facility: Karabuk University
Study officials:
affiliation: Karabuk University
name: Musa Güneş, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.