Actively Recruiting
Persistent Pain in Pharmacologically or Surgical Treated Osteoarthritis: Role of Mu-Limpho Marker
Led by IRCCS San Raffaele Roma · Updated on 2024-10-15
192
Participants Needed
1
Research Sites
129 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 and/or surgery interventions and rehabilitation * to characterize Mu+ B and NK cells in terms of maturation states, activation/inhibition 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. 1S)surgical 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 pharmacological/surgical 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.
CONDITIONS
Official Title
Persistent Pain in Pharmacologically or Surgical Treated Osteoarthritis: Role of Mu-Limpho Marker
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primary osteoarthritis with disabling pain
- Age older than 18 years at the time of surgery
- Ability to communicate with healthcare professionals and provide informed consent
- Willingness to participate in a 24-month follow-up
You will not qualify if you...
- Previous surgical knee joint procedures
- Intra-articular knee injection in the last 3 months
- Severe psychiatric disorder (excluding mild depression) or mental/cognitive impairment
- History of fracture or trauma within the last 3 months
- Immunodeficiency diseases within the last 6 months or currently
- Connective tissue disease within the last 6 months or currently
- Infections within the last 6 months or currently
- Pregnancy
- Current use of opioids
AI-Screening
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Trial Site Locations
Total: 1 location
1
IRCCS San Raffaele Roma
Roma, Roma, Italy, 00163
Actively Recruiting
Research Team
L
Lucia Gatta, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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