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NK-ORB Expression of Mu Receptor on Lymphocytes in Rehabilitation

Employment of Natural Killer Opioid Receptor as a Biomarker to Ameliorate the Efficacy of the Rehabilitation Program in a Patient-oriented Strategy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06458569
Acronym
NK-ORB
Enrollment
50
Registered
2024-06-13
Start date
2023-10-03
Completion date
2026-04-29
Last updated
2024-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Keywords

Chronic Pain, NK cells, Lymphocytes, Mu Opioid Receptor

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.

Detailed description

Pain is a serious global problem Based on the preliminary data, 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. All patients in the experimental group will undergo three blood sample collections at specific time points to evaluate the percentage of Mu-positive NK cells, and its modulation according to rehabilitation programs: the day of the enrollment (T0), at half part of the neuro rehabilitation programs (T1) and at the end of neuro-rehabilitation programs (T2). Particularly, the two study groups involved will be in a experimental group (50 consecutive patients who have an NRS \>5); a control group (50 patients who have an NRS \<5). Peripheral blood will be incubated with different fluorochrome-conjugated antibodies, specific for natural killer cells, in combination with anti-Mu Opioid Receptor (MOR) and the data will be analyze usin flow cytometer and FlowJo. The level of statistical significance will be fixed at p \< 0.05. Analyses will be carried out using GraphPad Prism software (v8.00; GraphPad Software). The results are expressed as mean ± SEM The expected results from this study could support the hypothesis that modulation of the µ opioid receptor on NK cells is a valid method for pain measurement, helping to establish an innovative approach in a rehabilitation program.

Interventions

OTHERRehabilitation

3-weeks rehabilitation in hospital

Sponsors

IRCCS San Raffaele Roma
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Identification of percentage of Mu-positive NK cells as predictive markers of pain in suffering patients3 weeksPeripheral 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.

Countries

Italy

Contacts

Primary ContactLucia Gatta, PhD
lucia.gatta@sanraffaele.it+390652253440
Backup ContactLucia Carmela Passacatini, Dr
carmela.passacatini@sanraffaele.it+390652253778

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026