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

February 13, 2024 updated by: Marmara University

Does Central Sensitization Mediate Neuropathic Complaints in Lumbar Disc Herniation? A Cross-sectional Observational Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
    • Fevzi Çakmak Mah, Muhsin Yazıcıoğlu Cd, Pendik
      • Istanbul, Fevzi Çakmak Mah, Muhsin Yazıcıoğlu Cd, Pendik, Turkey, 34899
        • Recruiting
        • Marmara University School of medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients
Patients with lumbar disc herniation
Diagnostic test: 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.
Other Names:
  • CSI
Other: 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.
Other Names:
  • SF-36
Other: Visual analogue scale
global pain score on a 0 to 10
Other Names:
  • VAS
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.
Other Names:
  • ODI
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.
Other Names:
  • DN4

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Central Sensitization Inventory (CSI)
Time Frame: 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.
6 months
DN4
Time Frame: 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.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
VAS pain
Time Frame: 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)
6 months
SF-36
Time Frame: 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.
6 months
ODI
Time Frame: 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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marmara University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Canan Şanal Toprak, Asst.Prof, Marmara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 16, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 10, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 12.01.2024.10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data that support the findings of this study are available from the corresponding author, upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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