NK-ORB Expression of Mu Receptor on Lymphocytes in Rehabilitation

NCT06458569 | Recruiting

• 1 other identifier: RP 22/30
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic pain is a serious disorder that causes physical suffering and emotional distress. NK cells are cytotoxic granular cells playing a crucial role in innate immunity. Recent studies described modulation of the percentage of B lymphocytes and NK cells expressing the μ opioid receptor as a potential marker for measuring pain. Neuropathic pain sufferers have decreased NK cell function, highlighting the need of further investigating the effect of opioid receptor expression on lympoid cells defining their potential relevance as a pain monitor marker. Opioid receptors expressed on NK, B and T cells are a possible candidate for objective monitoring of pain in patients.

Conditions

Fibromyalgia

Keywords

Chronic Pain, NK cells, Lymphocytes, Mu Opioid Receptor

Outcome Measures

Primary Outcomes (1)

• Identification of percentage of Mu-positive NK cells as predictive markers of pain in suffering patients

  Peripheral blood of pain suffering patients who have entered a neurorehabilitation program will be investigated to confirm the modulation of the percentage of Mu-positive NK cells and to evaluate if they could be eligible as predictive markers of chronic pain by correlating it to the level of pain calculated with Numeric Pain Rating Scale.

  3 weeks

Study Arms (2)

healthy subjects

subjects with NRS\<5

patients with cronical pain

patients with NRS\>5

Other: Rehabilitation

Interventions

Rehabilitation OTHER

3-weeks rehabilitation in hospital

patients with cronical pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Experimental group, patients who have an NRS \>5; * Control group, patients who have an NRS \<5.

You may qualify if:

• IRCCS San Raffaele Roma patients who entered the neuro-rehabilitation program, aged 18 years older, able to sign a written informed consent.

You may not qualify if:

• Patients with oncological or psychiatric diseases.
• Pregnant patients
• Patients with a severe psychiatric disorder (excluding mild depression) or mental/cognitive impairment

Sponsors & Collaborators

• IRCCS San Raffaele Roma: lead

Study Sites (1)

IRCCS San Raffaele

Roma, 00163, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood samples from patients in EDTA

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Lucia Gatta, PhD

CONTACT

+390652253440; lucia.gatta@sanraffaele.it

Lucia Carmela Passacatini, Dr

CONTACT

+390652253778; carmela.passacatini@sanraffaele.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 13, 2024
• Study Start: October 3, 2023
• Primary Completion: July 31, 2025
• Study Completion: April 29, 2026
• Last Updated: June 13, 2024

Record last verified: 2024-04

Locations

IT (1)