Chronic PainMLMNCT06637709
Persistent Pain in Pharmacologically or Surgical Treated Osteoarthritis: Role of Mu-Limpho Marker
An observational study of Chronic Pain and Osteo Arthritis Knee, run by IRCCS San Raffaele Roma at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Osteo Arthritis Knee
- How many people
- 192 participants
- Where
- 1 siteItaly
- Study dates
- 7 Nov 2023to 28 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: OA patients are referred to the Orthopedic and Traumatology Surgery Unit of the University Hospital Mater Domini (Catanzaro, Italy). The healthy subjects of the control group may be recruited not only from the Orthopedic and Traumatology Surgery Unit of the University Hospital Mater Domini but also from the IRCCS San Raffaele in Rome, during the corporate medical visit and from other approved studies.
Who may be able to join
- 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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS San Raffaele Roma
Roma, Roma, 00163
Valentina Malafoglia, PhD, +390652253440, valentina.malafoglia@sanraffele.it
Lucia Gatta, PhD, +390652253440, lucia.gatta@sanraffaele.it
About this study
Official title: Persistent Pain in Pharmacologically or Surgical Treated Osteoarthritis: the Role of the Mu-Lympho Marker As a Candidate Innovative Diagnostic Tool
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:
Read more
- 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 as their ability to respond to Mu stimulation, in order to understand whether these cells can have a role in the pathogenesis of OA associated CP
- to investigate the potential confounding effect of other biological and psychological elements in the relationship between the MLM and OA pain progression
Researchers will compare two study groups:
- Experimental group: subjects suffering from symptomatic knee OA. 1S)surgical subgroup: OA patients from the experimental group requiring primary TKA due to the failure of conservative treatment, thus undergoing surgical intervention;
- Control group: subjects without any chronic pain, undergoing occupational health surveillance matched by age, sex and psychological profile with the experimental group patients Participants will be asked to do blood sample collections at specific time points to evaluate MLM stability over time and its modulation according to pharmacological/surgical and rehabilitation interventions. Subjects in the control group will undergo 2 blood sample collections. Pain assessment will be performed at all scheduled time points to correlate pain severity with Mu expression in B and NK cells.
Read the detailed description
All patients will undergo the blood sampling at the day of the enrollment (T0), at 1 month (T1), 3 months (T2) and 6 months(T3) after the enrollment. The subgroup of patients requiring primary TKA will undergo blood sampling the day of the surgical intervention (T1-S), the 5th day (T2-S), and the 90th day after the intervention (T3-S). Pain-free subjects will undergo blood sampling the day of the enrollment (T0) and 6 months (T3) later.
Participants will be asked to self-fill the 11-point numerical rating scale (NRS) test, where 0= No pain and 10= worst possible pain, 2) the Italian version of the Brief Pain Inventory and the Italian version of the Neuropathic Pain Symptom Inventory NPSI (I-NPSI), 3) the Italian version of the Knee injury and Osteoarthritis Outcome Score (KOOS).
- Conditions
- Chronic Pain, Osteo Arthritis Knee
- Keywords
- pain biomarkers, Mu opioid receptor, tailored therapy
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group: patients with symptomatic knee osteoarthritis (OA) | Experimental group includes a subgroup: OA patients from the experimental group requiring primary TKA due to the failure of conservative treatment, thus undergoing surgical intervention. | |
| Control group: subjects without any chronic pain | subjects undergoing occupational health surveillance matched by age, sex and psychological profile with the experimental group patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of differences in the percentage of Mu opioid receptor positive B and NK cells between experimental and control groups.
Characterization of Mu opioid receptor positive B/NK cells percentage of expression as a candidate biomarker for assessing the risk of pain persistency and chronicization following pharmacological, surgical, and/or rehabilitation interventions.
Measured: 3 years
Secondary outcomes (1)
Correlations between biological and psychological outcomes
The analysis of correlation between bilogical and psychological data will help to mitigate potential confounding effects and to optimized rehabilitation strategies based on study findings
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start7 Nov 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion28 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele Roma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637709
- Sponsor's protocol ID
- RP 22/23
- Acronym
- MLM
- Status last verified
- Oct 2024
- First submitted
- 9 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistent Pain in Pharmacologically or Surgical Treated Osteoarthritis: the Role of the Mu-Lympho Marker As a Candidate Innovative Diagnostic Tool
- ClinicalTrials.gov ID
- NCT06637709
- Acronym / sponsor ID
- MLM / RP 22/23
- Conditions
- Chronic Pain, Osteo Arthritis Knee
- Keywords
- pain biomarkers, Mu opioid receptor, tailored therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- IRCCS San Raffaele RomaUniversity, hospital or other
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 28 Apr 2026 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 as their ability to respond to Mu stimulation, in order to understand whether these cells can have a role in the pathogenesis of OA associated CP
- to investigate the potential confounding effect of other biological and psychological elements in the relationship between the MLM and OA pain progression
Researchers will compare two study groups:
- Experimental group: subjects suffering from symptomatic knee OA. 1S)surgical subgroup: OA patients from the experimental group requiring primary TKA due to the failure of conservative treatment, thus undergoing surgical intervention;
- Control group: subjects without any chronic pain, undergoing occupational health surveillance matched by age, sex and psychological profile with the experimental group patients Participants will be asked to do blood sample collections at specific time points to evaluate MLM stability over time and its modulation according to pharmacological/surgical and rehabilitation interventions. Subjects in the control group will undergo 2 blood sample collections. Pain assessment will be performed at all scheduled time points to correlate pain severity with Mu expression in B and NK cells.
Detailed description
All patients will undergo the blood sampling at the day of the enrollment (T0), at 1 month (T1), 3 months (T2) and 6 months(T3) after the enrollment. The subgroup of patients requiring primary TKA will undergo blood sampling the day of the surgical intervention (T1-S), the 5th day (T2-S), and the 90th day after the intervention (T3-S). Pain-free subjects will undergo blood sampling the day of the enrollment (T0) and 6 months (T3) later.
Participants will be asked to self-fill the 11-point numerical rating scale (NRS) test, where 0= No pain and 10= worst possible pain, 2) the Italian version of the Brief Pain Inventory and the Italian version of the Neuropathic Pain Symptom Inventory NPSI (I-NPSI), 3) the Italian version of the Knee injury and Osteoarthritis Outcome Score (KOOS).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group: patients with symptomatic knee osteoarthritis (OA) | – | –Experimental group includes a subgroup: OA patients from the experimental group requiring primary TKA due to the failure of conservative treatment, thus undergoing surgical intervention. |
| Control group: subjects without any chronic pain | – | –subjects undergoing occupational health surveillance matched by age, sex and psychological profile with the experimental group patients |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- OA patients are referred to the Orthopedic and Traumatology Surgery Unit of the University Hospital Mater Domini (Catanzaro, Italy). The healthy subjects of the control group may be recruited not only from the Orthopedic and Traumatology Surgery Unit of the University Hospital Mater Domini but also from the IRCCS San Raffaele in Rome, during the corporate medical visit and from other approved studies.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of differences in the percentage of Mu opioid receptor positive B and NK cells between experimental and control groups.
Time frame: 3 years
Characterization of Mu opioid receptor positive B/NK cells percentage of expression as a candidate biomarker for assessing the risk of pain persistency and chronicization following pharmacological, surgical, and/or rehabilitation interventions.
1 secondary outcome
Correlations between biological and psychological outcomes
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
Related trials for Chronic Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Osteo Arthritis Knee, run by IRCCS San Raffaele Roma at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucia Gatta, PhD (+390652253440, lucia.gatta@sanraffaele.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of differences in the percentage of Mu opioid receptor positive B and NK cells between experimental and control groups. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.