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Completed

NCT Number: NCT07001982

Lumbar Spinal Stenosis and Central Sensitization

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.

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Key information

Conditions

Lumbar Spinal Stenosis Bone Diseases Musculoskeletal Diseases Spinal Diseases Spinal Stenosis

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Karabuk University

Karabük, 78000, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Central sensitization

    Time frame: 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.

  2. Pain severity

    Time frame: 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.

  3. Pain pressure threshold

    Time frame: Baseline

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

  4. Disability levels

    Time frame: 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.

  5. Pain catastrophizing

    Time frame: 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.

  6. Sleep quality

    Time frame: 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.

  7. Depression

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Karabuk University

Other

Registry information

Official study title

The Relationship Central Sensitization, Pain and Depression Patients With Lumbar Spinal Stenosis

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 3, 2025
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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