Investigation of the Relationship Between Central Sensitization and Neuropathic Pain in Lumbar Disc Herniation

NCT06269068 | Recruiting

• 1 other identifier: 12.01.2024.10
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Central sensitization (CS) is as increased response to normal or sub-threshold stimuli of central nervous system and its close relationship with in many musculoskeletal diseases with chronic pain has been demonstrated in several studies. CS is also one of the main mechanisms proposed in the generation of neuropathic pain, and the relationship between pain sensitization and neuropathic complaints has been shown in different diseases.In this study, it was aimed to investigate the effect of central sensitization on the distribution pattern and neuropathic character of pain in patients with lumbar disc herniation who applied to the physical medicine and rehabilitation outpatient clinic.

Conditions

Central Sensitisation

Keywords

Central sensitisation; Lumbar Disc Herniation; Neuropathic Pain; Central sensitization inventory

Outcome Measures

Primary Outcomes (2)

• Central Sensitization Inventory (CSI)

  25 somatic and psychosocial symptoms, which are frequently found in patients with central sensitization in part A, are questioned. In part B, the presence of diseases whose relationship with central sensitization is well defined is questioned in the patient without participating in scoring. Central sensitization is assumed in patients who score 40 or more over 100 points.

  6 months

• DN4

  The DN4 scale was developed in 2005 to detect the neuropathic component of pain.This questionnaire consists of 10 items; While the nature of pain is questioned in 7 items, the other 3 items include brief sensory examination. Patients with a score of 4 or more out of 10 are considered to have neuropathic pain.

  6 months

Secondary Outcomes (3)

• VAS pain

  6 months

• SF-36

  6 months

• ODI

  6 months

Study Arms (1)

Patients

Patients with lumbar disc herniation

Diagnostic Test: Central sensitization inventory; Other: Short form-36; Other: Oswestry Low Back Pain Disability Questionnaire; Other: Douleur Neuropathique 4; Other: Visual analogue scale

Interventions

Central sensitization inventory DIAGNOSTIC_TEST

Standardized questionnaire to determine the level of central sensitization. Patients with a score of 40 and above are considered to have central sensitization.

Also known as: CSI

Patients

Short form-36 OTHER

Standardized questionnaire to investigate the quality of life in patients. The score of the scale is between 0-100. The higher scores are associated with greater deterioration in quality of life.

Also known as: SF-36

Patients

Oswestry Low Back Pain Disability Questionnaire OTHER

With this scale, it is questioned to what extent the patient is affected by low back pain in selected daily living activities under certain ten headings. In total scoring, disability is expressed as a percentage, and high scores are interpreted in favor of an increase in disability.

Also known as: ODI

Patients

Douleur Neuropathique 4 OTHER

The questionnaire consists of 10 items; while the nature of pain is questioned in 7 items, the other 3 items include brief sensory examination. Patients with a score of 4 or more out of 10 are considered to have neuropathic pain.

Also known as: DN4

Patients

Visual analogue scale OTHER

global pain score on a 0 to 10

Also known as: VAS

Patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The patients aged 18-65 years diagnosed with lumbar disc herniation will be recruited from a PMR outpatient clinic of a state hospital

You may qualify if:

• Having a diagnosis of lumbar disc herniation Accepting to participate in the study

You may not qualify if:

• Concomitant active systemic inflammatory disease, infection and malignancy Having disease that will cause neuropathic pain in the other lower extremity, such as polyneuropathy, multiple sclerosis etc Refusing to participate in the study

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University School of Medicine

Istanbul, Fevzi Çakmak Mah, Muhsin Yazıcıoğlu Cd, Pendik, 34899, Turkey (Türkiye)

RECRUITING

Related Publications (7)

• Al Qaraghli MI, De Jesus O. Lumbar Disc Herniation. 2023 Aug 23. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK560878/

  PMID: 32809713 BACKGROUND

• Bogduk N. On the definitions and physiology of back pain, referred pain, and radicular pain. Pain. 2009 Dec 15;147(1-3):17-9. doi: 10.1016/j.pain.2009.08.020. Epub 2009 Sep 16. No abstract available.

  PMID: 19762151 BACKGROUND

• Dower A, Davies MA, Ghahreman A. Pathologic Basis of Lumbar Radicular Pain. World Neurosurg. 2019 Aug;128:114-121. doi: 10.1016/j.wneu.2019.04.147. Epub 2019 Apr 25.

  PMID: 31028982 BACKGROUND

• Meacham K, Shepherd A, Mohapatra DP, Haroutounian S. Neuropathic Pain: Central vs. Peripheral Mechanisms. Curr Pain Headache Rep. 2017 Jun;21(6):28. doi: 10.1007/s11916-017-0629-5.

  PMID: 28432601 BACKGROUND

• Huang Y, Li Y, Zhong X, Hu Y, Liu P, Zhao Y, Deng Z, Liu X, Liu S, Zhong Y. Src-family kinases activation in spinal microglia contributes to central sensitization and chronic pain after lumbar disc herniation. Mol Pain. 2017 Jan-Dec;13:1744806917733637. doi: 10.1177/1744806917733637.

  PMID: 28952414 BACKGROUND

• Akeda K, Takegami N, Yamada J, Fujiwara T, Nishimura A, Sudo A. Central Sensitization in Chronic Low Back Pain: A Population-Based Study of a Japanese Mountain Village. J Pain Res. 2021 May 18;14:1271-1280. doi: 10.2147/JPR.S301924. eCollection 2021.

  PMID: 34040431 BACKGROUND

• Mayer TG, Neblett R, Cohen H, Howard KJ, Choi YH, Williams MJ, Perez Y, Gatchel RJ. The development and psychometric validation of the central sensitization inventory. Pain Pract. 2012 Apr;12(4):276-85. doi: 10.1111/j.1533-2500.2011.00493.x. Epub 2011 Sep 27.

  PMID: 21951710 BACKGROUND

Related Links

• SF-36

MeSH Terms

Conditions

Intervertebral Disc Displacement; Neuralgia

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Canan Şanal Toprak, Asst.Prof

  Marmara University

  STUDY CHAIR

Central Study Contacts

Feyza Nur Yücel

CONTACT

5385577059; dr.fny28@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 21, 2024
• Study Start: January 16, 2024
• Primary Completion: April 10, 2024
• Study Completion: June 1, 2024
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)