NCT06637709 Persistent Pain in Pharmacologically or Surgical Treated Osteoarthritis: Role of Mu-Limpho Marker
| NCT ID | NCT06637709 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS San Raffaele Roma |
| Condition | Chronic Pain |
| Study Type | OBSERVATIONAL |
| Enrollment | 192 participants |
| Start Date | 2023-11-07 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 192 participants in total. It began in 2023-11-07 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: * primary osteoarthritis with disabling pain, age older than 18 years at the time of surgery, capability tocommunicate with healthcare professionals and give valid informed consent, and a willingness to participate in a 24-month follow-up. Exclusion Criteria: * (1) patients who underwent: surgical knee joint procedures; intra-articular knee injection in the last 3 months; (2) patients with: severe psychiatric disorder \[excluding mild depression\] or mental/cognitive impairment; a history \[in the last 3 months\] of fracture or trauma; (3) patients with a history in the last 6 months or currently suffering from: immunodeficiency diseases; connective tissue disease; infections; (4) pregnancy (5) patients ongoing opioids.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06637709 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Chronic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06637709 currently recruiting?
Yes, NCT06637709 is actively recruiting participants. Contact the research team at lucia.gatta@sanraffaele.it for enrollment information.
Where is the NCT06637709 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT06637709 clinical trial?
NCT06637709 is sponsored by IRCCS San Raffaele Roma. The trial plans to enroll 192 participants.
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