Central SensitisationNCT06269068
Investigation of the Relationship Between Central Sensitization and Neuropathic Pain in Lumbar Disc Herniation
An observational study of Central Sensitisation, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Central Sensitisation
- What is being tested?
- Central sensitization inventory, Short form-36 and Oswestry Low Back Pain Disability Questionnaire
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Jan 2024to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Having a diagnosis of lumbar disc herniation Accepting to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University School of Medicine
Istanbul, Fevzi Çakmak Mah, Muhsin Yazıcıoğlu Cd, Pendik, 34899
Feyza Nur Yücel, 5385577059, dr.fny28@gmail.com
About this study
Official title: 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.
Read the 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
- Being tested
- Central sensitization inventory, Short form-36, Oswestry Low Back Pain Disability Questionnaire, Douleur Neuropathique 4, Visual analogue scale
- Keywords
- Central sensitisation, Lumbar Disc Herniation, Neuropathic Pain, Central sensitization inventory
- Medical subject headings
- Intervertebral Disc Displacement, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Central sensitization inventoryDiagnostic test
Also called CSI
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-36Other
Also called SF-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.
Oswestry Low Back Pain Disability QuestionnaireOther
Also called ODI
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 4Other
Also called DN4
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 scaleOther
Also called VAS
global pain score on a 0 to 10
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with lumbar disc herniation Receives: Diagnostic Test: Central sensitization inventory; Other: Short form-36; Other: Oswestry Low Back Pain Disability Questionnaire; Other: Douleur Neuropathique 4; Other: Visual analogue scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Secondary outcomes (3)
VAS pain
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)
Measured: 6 months
SF-36
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.
Measured: 6 months
ODI
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start16 Jan 2024
- Primary completion10 Apr 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Central SensitisationStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Canan Şanal Toprak, Asst.Prof, Study chair, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269068
- Sponsor's protocol ID
- 12.01.2024.10
- Status last verified
- Feb 2024
- First submitted
- 13 Feb 2024
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that support the findings of this study are available from the corresponding author, upon reasonable request.
Publications
Al Qaraghli MI, De Jesus O. Lumbar Disc Herniation. 2023 Aug 23. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK560878/
PubMed 32809713Bogduk 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.
PubMed 19762151Dower 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.
PubMed 31028982Meacham 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.
PubMed 28432601Huang 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.
PubMed 28952414Akeda 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.
PubMed 34040431Mayer 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.
PubMed 21951710
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Central Sensitization Mediate Neuropathic Complaints in Lumbar Disc Herniation? A Cross-sectional Observational Study
- ClinicalTrials.gov ID
- NCT06269068
- Acronym / sponsor ID
- 12.01.2024.10
- Conditions
- Central Sensitisation
- Keywords
- Central sensitisation, Lumbar Disc Herniation, Neuropathic Pain, Central sensitization inventory
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 16 Jan 2024 (actual)
- Primary completion
- 10 Apr 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Diagnostic Test: Central sensitization inventory, Other: Short form-36, Other: Oswestry Low Back Pain Disability Questionnaire, Other: Douleur Neuropathique 4, Other: Visual analogue scalePatients with lumbar disc herniation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Having a diagnosis of lumbar disc herniation Accepting to participate in the study
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Central sensitization inventoryAlso: CSIStandardized questionnaire to determine the level of central sensitization. Patients with a score of 40 and above are considered to have central sensitization. | Diagnostic test | Patients |
| Short form-36Also: SF-36Standardized 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 | Patients |
| Oswestry Low Back Pain Disability QuestionnaireAlso: ODIWith 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 | Patients |
| Douleur Neuropathique 4Also: DN4The 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 | Patients |
| Visual analogue scaleAlso: VASglobal pain score on a 0 to 10 | Other | Patients |
Primary outcome
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.
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.
3 secondary outcomes
VAS pain
Time frame: 6 months
SF-36
Time frame: 6 months
ODI
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Background: PubMed 32809713Al Qaraghli MI, De Jesus O. Lumbar Disc Herniation. 2023 Aug 23. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK560878/
- Background: PubMed 19762151Bogduk 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.
- Background: PubMed 31028982Dower 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.
- Background: PubMed 28432601Meacham 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.
- Background: PubMed 28952414Huang 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.
- Background: PubMed 34040431Akeda 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.
- Background: PubMed 21951710Mayer 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.
- Individual participant dataSharing planned: No. The data that support the findings of this study are available from the corresponding author, upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Canan Şanal Toprak, Asst.Prof study chair
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Sensitisation, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feyza Nur Yücel (5385577059, dr.fny28@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central Sensitization Inventory (CSI) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06269068, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.