Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06637709
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-09
Brief Title:
Persistent Pain in Pharmacologically or Surgical Treated Osteoarthritis Role of Mu-Limpho Marker
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Persistent Pain in Pharmacologically or Surgical Treated Osteoarthritis the Role of the Mu-Lympho Marker As a Candidate Innovative Diagnostic Tool
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MLM
Brief Summary:
The goal of this prospective observational study is to analyze the percentage of expression of B and NK cells expressing Mu opioid receptor on their surface named Mu-Lympho-Marker MLM to measure pain progression in Osteoarthritis patients and its association with specific rehabilitation programs In particular we want to analyze the role of MLM as diagnostic biomarker of pain chronicization
The main aims are
to explore the relationship between Mu B and NK cells percentage and pain progression in OA patients also investigating whether this characteristic is associated to particular outcome of pharmacological andor surgery interventions and rehabilitation
to characterize Mu B and NK cells in terms of maturation states activationinhibition and functional properties as well as their ability to respond to Mu stimulation in order to understand whether these cells can have a role in the pathogenesis of OA associated CP
to investigate the potential confounding effect of other biological and psychological elements in the relationship between the MLM and OA pain progression
Researchers will compare two study groups
1 Experimental group subjects suffering from symptomatic knee OA 1Ssurgical subgroup OA patients from the experimental group requiring primary TKA due to the failure of conservative treatment thus undergoing surgical intervention
2 Control group subjects without any chronic pain undergoing occupational health surveillance matched by age sex and psychological profile with the experimental group patients Participants will be asked to do blood sample collections at specific time points to evaluate MLM stability over time and its modulation according to pharmacologicalsurgical and rehabilitation interventions Subjects in the control group will undergo 2 blood sample collections Pain assessment will be performed at all scheduled time points to correlate pain severity with Mu expression in B and NK cells
The main aims are
to explore the relationship between Mu B and NK cells percentage and pain progression in OA patients also investigating whether this characteristic is associated to particular outcome of pharmacological andor surgery interventions and rehabilitation
to characterize Mu B and NK cells in terms of maturation states activationinhibition and functional properties as well as their ability to respond to Mu stimulation in order to understand whether these cells can have a role in the pathogenesis of OA associated CP
to investigate the potential confounding effect of other biological and psychological elements in the relationship between the MLM and OA pain progression
Researchers will compare two study groups
1 Experimental group subjects suffering from symptomatic knee OA 1Ssurgical subgroup OA patients from the experimental group requiring primary TKA due to the failure of conservative treatment thus undergoing surgical intervention
2 Control group subjects without any chronic pain undergoing occupational health surveillance matched by age sex and psychological profile with the experimental group patients Participants will be asked to do blood sample collections at specific time points to evaluate MLM stability over time and its modulation according to pharmacologicalsurgical and rehabilitation interventions Subjects in the control group will undergo 2 blood sample collections Pain assessment will be performed at all scheduled time points to correlate pain severity with Mu expression in B and NK cells
Detailed Description:
All patients will undergo the blood sampling at the day of the enrollment T0 at 1 month T1 3 months T2 and 6 monthsT3 after the enrollment The subgroup of patients requiring primary TKA will undergo blood sampling the day of the surgical intervention T1-S the 5th day T2-S and the 90th day after the intervention T3-S Pain-free subjects will undergo blood sampling the day of the enrollment T0 and 6 months T3 later
Participants will be asked to self-fill the 11-point numerical rating scale NRS test where 0 No pain and 10 worst possible pain 2 the Italian version of the Brief Pain Inventory and the Italian version of the Neuropathic Pain Symptom Inventory NPSI I-NPSI 3 the Italian version of the Knee injury and Osteoarthritis Outcome Score KOOS
Participants will be asked to self-fill the 11-point numerical rating scale NRS test where 0 No pain and 10 worst possible pain 2 the Italian version of the Brief Pain Inventory and the Italian version of the Neuropathic Pain Symptom Inventory NPSI I-NPSI 3 the Italian version of the Knee injury and Osteoarthritis Outcome Score KOOS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None