An observational study in Fibromyalgia, sponsored by IRCCS San Raffaele Roma. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-13.
Sponsored by IRCCS San Raffaele Roma · Observational
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.
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.
1,336 studies on the registry are indexed under Fibromyalgia; 265 are open to participants now.
This study's planned enrollment of 50 is below the median of 100 across 270 observational studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →IRCCS San Raffaele Roma is the lead sponsor of 63 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
IRCCS San Raffaele Roma patients who entered the neuro-rehabilitation program, aged 18 years older, able to sign a written informed consent.
Exclusion Criteria:
subjects with NRS\<5
patients with NRS\>5
Other: Rehabilitation
3-weeks rehabilitation in hospital
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.
Time frame: 3 weeks
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IRCCS San Raffaele Roma