Persistent Pain in Pharmacologically or Surgical Treated Osteoarthritis: Role of Mu-Limpho Marker

ConditionsChronic Pain Osteo Arthritis Knee

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-99

SponsorIRCCS San Raffaele Roma

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

(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.

Trial population

OA patients are referred to the Orthopedic and Traumatology Surgery Unit of the University Hospital Mater Domini (Catanzaro, Italy). The healthy subjects of the control group may be recruited not only from the Orthopedic and Traumatology Surgery Unit of the University Hospital Mater Domini but also from the IRCCS San Raffaele in Rome, during the corporate medical visit and from other approved studies.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

192 Participants

are grouped into 2 trial groups

Group A: Experimental group: patients with symptomatic knee osteoarthritis (OA)

Group B: Control group: subjects without any chronic pain

Trial outcomes

Primary outcomes

Identification of differences in the percentage of Mu opioid receptor positive B and NK cells between experimental and control groups.

Characterization of Mu opioid receptor positive B/NK cells percentage of expression as a candidate biomarker for assessing the risk of pain persistency and chronicization following pharmacological, surgical, and/or rehabilitation interventions.

Time frame

3 years

Secondary outcomes

Correlations between biological and psychological outcomes

The analysis of correlation between bilogical and psychological data will help to mitigate potential confounding effects and to optimized rehabilitation strategies based on study findings

Time frame

3 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IRCCS San Raffaele Roma

Lead sponsor

Source ClinicalTrials.gov

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