Investigating Mu Receptor Expression on Lymphocytes in Chronic Pain Rehabilitation
Employment of Natural Killer Opioid Receptor as a Biomarker to Ameliorate the Efficacy of the Rehabilitation Program in a Patient-oriented Strategy
This study is trying to see if measuring certain immune cells in the blood can help understand and track pain levels in people with fibromyalgia who are going through rehabilitation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS San Raffaele Roma Academic / other |
| Locations | 1 site (Roma) |
| Trial ID | NCT06458569 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the expression of the Mu opioid receptor on natural killer (NK) cells and lymphocytes in patients undergoing neuro-rehabilitation for chronic pain, specifically fibromyalgia. It will involve collecting blood samples from participants at three different time points to assess the modulation of Mu-positive NK cells and their potential as predictive markers for pain. The study will compare an experimental group of patients with higher pain levels to a control group with lower pain levels, utilizing flow cytometry for analysis. The goal is to establish a novel method for objectively monitoring pain through immune cell markers.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are enrolled in a neuro-rehabilitation program for chronic pain and can provide informed consent.
Not a fit: Patients with oncological or severe psychiatric diseases, pregnant individuals, or those with significant cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new objective method for measuring chronic pain, potentially improving rehabilitation outcomes for patients.
How similar studies have performed: While the approach of using immune cell markers for pain measurement is innovative, similar studies have shown promise in exploring immune responses in chronic pain conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Roma
- IRCCS San Raffaele — Roma, Italy (Recruiting)
Study contacts
- Study coordinator: Lucia Gatta, PhD
- Email: lucia.gatta@sanraffaele.it
- Phone: +390652253440
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.