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

NCT ID: NCT06637709

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 192 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-07
• Study Completion Date: 2026-04-28

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.

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 months(T3) 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).

Conditions

Chronic Pain; Osteo Arthritis Knee

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Experimental group: patients with symptomatic knee osteoarthritis (OA)

Experimental group includes a subgroup: OA patients from the experimental group requiring primary TKA due to the failure of conservative treatment, thus undergoing surgical intervention.

No interventions assigned to this group

Control group: subjects without any chronic pain

subjects undergoing occupational health surveillance matched by age, sex and psychological profile with the experimental group patients

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

IRCCS San Raffaele Roma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IRCCS San Raffaele Roma

Roma, Roma, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Lucia Gatta, PhD

Role: CONTACT

lucia.gatta@sanraffaele.it

+390652253440

Facility Contacts

Valentina Malafoglia, PhD

Role: primary

valentina.malafoglia@sanraffele.it

+390652253440

Lucia Gatta, PhD

Role: backup

lucia.gatta@sanraffaele.it

+390652253440

Other Identifiers

RP 22/23

Identifier Type: -

Identifier Source: org_study_id