Analyzing pain biomarkers in osteoarthritis patients
Persistent Pain in Pharmacologically or Surgical Treated Osteoarthritis: the Role of the Mu-Lympho Marker As a Candidate Innovative Diagnostic Tool
IRCCS San Raffaele Roma · NCT06637709
This study is testing if certain immune cells in the blood can help doctors understand and manage chronic pain in people with osteoarthritis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 192 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | IRCCS San Raffaele Roma (other) |
| Locations | 1 site (Roma, Roma) |
| Trial ID | NCT06637709 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the expression of Mu opioid receptors on B and NK cells in patients with chronic pain due to osteoarthritis. By measuring the percentage of these cells and their association with pain progression, the study seeks to identify Mu-Lympho-Marker (MLM) as a potential diagnostic biomarker for chronic pain. Participants will undergo blood sampling at various intervals and complete pain assessment questionnaires to evaluate their pain levels and response to rehabilitation programs. The study will also explore the functional properties of these immune cells in relation to pain management.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with primary osteoarthritis experiencing disabling pain.
Not a fit: Patients who have undergone recent knee surgeries or injections, or those with severe psychiatric disorders or ongoing opioid use may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic methods and tailored therapies for managing chronic pain in osteoarthritis patients.
How similar studies have performed: While the specific approach of analyzing Mu-Lympho-Marker is novel, similar studies have shown promise in understanding pain mechanisms and biomarkers in chronic pain conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * primary osteoarthritis with disabling pain, age older than 18 years at the time of surgery, capability tocommunicate with healthcare professionals and give valid informed consent, and a willingness to participate in a 24-month follow-up. Exclusion Criteria: * (1) patients who underwent: surgical knee joint procedures; intra-articular knee injection in the last 3 months; (2) patients with: severe psychiatric disorder \[excluding mild depression\] or mental/cognitive impairment; a history \[in the last 3 months\] of fracture or trauma; (3) patients with a history in the last 6 months or currently suffering from: immunodeficiency diseases; connective tissue disease; infections; (4) pregnancy (5) patients ongoing opioids.
Where this trial is running
Roma, Roma
- IRCCS San Raffaele Roma — Roma, 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.
Conditions: Chronic Pain, Osteo Arthritis Knee, pain biomarkers, Mu opioid receptor, tailored therapy