Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06458569
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-10
Brief Title:
NK-ORB Expression of Mu Receptor on Lymphocytes in Rehabilitation
Sponsor:
IRCCS San Raffaele Roma
Organization:
IRCCS San Raffaele Roma
Study Overview
Official Title:
Employment of Natural Killer Opioid Receptor as a Biomarker to Ameliorate the Efficacy of the Rehabilitation Program in a Patient-oriented Strategy
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NK-ORB
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
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 005 Analyses will be carried out using GraphPad Prism software v800 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
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 005 Analyses will be carried out using GraphPad Prism software v800 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None