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

Recruiting

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

• Registration Number: NCT06269068
• Lead Sponsor: Marmara University

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.

Study Timeline

• Study Start: 2024-01-16
• Status Verified: 2024-02
• Study First Submitted: 2024-02-13
• Study First Submitted QC: 2024-02-13
• Last Update Submitted: 2024-02-13
• Study First Posted: 2024-02-21
• Last Update Posted: 2024-02-21
• Primary Completion: 2024-04-10
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Central sensitization inventory	Patients with lumbar disc herniation
Patients	Visual analogue scale	Patients with lumbar disc herniation
Patients	Short form-36	Patients with lumbar disc herniation
Patients	Oswestry Low Back Pain Disability Questionnaire	Patients with lumbar disc herniation
Patients	Douleur Neuropathique 4	Patients with lumbar disc herniation

Primary Outcome Measures

Name	Time	Method
Central Sensitization Inventory (CSI)	6 months	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.
DN4	6 months	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.

Secondary Outcome Measures

Name	Time	Method
VAS pain	6 months	The patients pain severity will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable)
ODI	6 months	This scale was developed for assessing the severity of disability in chronic low back pain patients. This scale consists of 10 items that evaluates the limitation of daily life activities of patients in the last month.It is accepted that the higher the score, the higher disability.
SF-36	6 months	The 36-Item Short Form Survey (SF-36) is an oft-used, well-researched, self-reported measure of health.The scale was developed by Ware in 1987 and consists of 36 questions questioning 8 sub-parameters regarding the health status of the person.These parameters are physical function, pain, limitation due to physical and emotional problems, emotional well-being, social function, fatigue and general health perception.

Trial Locations

Locations (1)

Marmara University School of Medicine; 🇹🇷 Istanbul, Fevzi Çakmak Mah, Muhsin Yazıcıoğlu Cd, Pendik, Turkey