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

NCT ID: NCT06269068

Last Updated: 2024-02-21

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 180 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-16
• Study Completion Date: 2024-06-01

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.

Detailed Description

Lumbar disc herniation (LDH) is one of the leading causes of musculoskeletal pain and its lifetime prevalence is around 80%. Different types of pain can be seen in patients with LDH, which are classified by the International Association for the Study of Pain (IASP) as nociceptive low back pain, somatic referred pain, radicular pain, and radiculopathy. While nociceptive low back pain originates from the structures in the lumbar spine, this pain is characterized as somatic referred pain when it spreads to the lower extremities. Radicular pain is different from these two pains in mechanism and character, and neuropathic complaints accompany axial pain. LDH is also the most common cause of lumbar radicular pain and causes neuropathic pain by irritation of the spinal nerve or dorsal root ganglion. In recent studies, it has been shown that nociceptor hyperexcitability and continuous stimulus discharge into the central nervous system play an important role in the formation of neuropathic pain. This mechanism is also encountered in central sensitization (CS), which is well-known to be associated with chronic pain and characterized by increased response to painful stimuli. Although there are many definitions of CS in the literature, one of the most comprehensive definitions was made as "Changes in the membrane excitability of the central pain pathways and changes in the synaptic transmission of the dorsal anterior horn cells and a decrease in the inhibition of the descending pathways". In animal models, inflammation-mediated spinal microglia activation has been shown to play a role in chronic radicular pain secondary to disc herniation, which has been associated with the development of central sensitization. A study showed that the frequency of CS is increased in patients with chronic low back pain, and this rate is variable in patients with LDH. In addition, data on the role of CS in LDH-related pain, especially radicular pain, are increasing.Considering all these data, CS is likely to affect pain in various ways in patients with LDH, particularly in its severity, extent, and neuropathic component. Therefore, in this study, it was aimed to investigate the relationship between CS accompanying LDH patients with pain characteristics and neuropathic pain development.

Conditions

Central Sensitisation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Patients

Patients with lumbar disc herniation

Central sensitization inventory

Intervention Type: 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.

Short form-36

Intervention Type: 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.

Oswestry Low Back Pain Disability Questionnaire

Intervention Type: 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.

Douleur Neuropathique 4

Intervention Type: 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.

Visual analogue scale

Intervention Type: OTHER

global pain score on a 0 to 10

Interventions

Central sensitization inventory

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

Intervention Type: DIAGNOSTIC_TEST

Short form-36

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.

Intervention Type: OTHER

Oswestry Low Back Pain Disability Questionnaire

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.

Intervention Type: OTHER

Douleur Neuropathique 4

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.

Intervention Type: OTHER

Visual analogue scale

global pain score on a 0 to 10

Intervention Type: OTHER

Other Intervention Names

CSI; SF-36; ODI; DN4; VAS

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marmara University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Canan Şanal Toprak, Asst.Prof

Role: STUDY_CHAIR

Marmara University

Locations

Marmara University School of Medicine

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

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Feyza Nur Yücel

Role: CONTACT

dr.fny28@gmail.com

5385577059

Facility Contacts

Feyza Nur Yücel

Role: primary

dr.fny28@gmail.com

5385577059

References

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/

Reference Type: BACKGROUND

PMID: 32809713 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19762151 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31028982 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28432601 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28952414 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34040431 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21951710 (View on PubMed)

Other Identifiers

12.01.2024.10

Identifier Type: -

Identifier Source: org_study_id