Persistent Pain in Pharmacologically or Surgical Treated Osteoarthritis: Role of Mu-Limpho
The goal of this prospective observational study is to analyze the percentage of expression of B and NK cells expressing Mu opioid receptor on their surface, named Mu-Lympho-Marker (MLM), to measure pain progression in Osteoarthritis patients and its association with specific rehabilitation programs. In particular, we
| Condition(s) | Chronic Pain, Osteo Arthritis Knee |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | The goal of this prospective observational study is to analyze the percentage of expression of B and NK cells expressing Mu opioid receptor on their surface, named Mu-Lympho-Marker (MLM), to measure pain progression in Osteoarthritis patients and its association with specific rehabilitation programs. In particular, we want to analyze the role of MLM as diagnostic biomarker of pain chronicization. The main aims are: * to explore the relationship between Mu+ B and NK cells percentage and pain progression in OA patients, also investigating whether this characteristic is associated to particular outcome of pharmacological and/or surgery interventions and rehabilitation * to characterize Mu+ B and NK cells in terms of maturation states, activation/inhibition and functional properties, as well a |
| Who can participate | 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. |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | IRCCS San Raffaele Roma |
| Locations | Roma, Roma, Italy |
| Start date | 2023-11-07 |
| NCT ID | NCT06637709 |
| Official listing | https://clinicaltrials.gov/study/NCT06637709 |