Actively Recruiting
ACU_Knee - Role of Acupuncture in Knee Prosthetic Surgery: Analgesia, Functional Outcome and Inflammatory Markers
Led by Fondazione IRCCS Policlinico San Matteo di Pavia · Updated on 2025-08-14
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the role of acupuncture in managing pain and improving outcomes after total knee replacement surgery (TKA) for patients with primary osteoarthritis. This study aims to assess whether acupuncture can help control acute pain, prevent chronic pain, improve joint function, and increase patient satisfaction. The research also examines how acupuncture influences inflammation by measuring specific biomarkers, which may relate to recovery and long-term joint stiffness. Participants will receive standard anesthesiology care including sedation, regional nerve blocks, and pain medications. They will be randomly assigned to either a standard treatment group or an acupuncture group, which receives additional acupuncture and auriculotherapy sessions before and after surgery. The acupuncture treatment targets specific body and ear points over multiple sessions during the first three days post-surgery. Throughout the study, participants will be monitored regularly for pain levels, medication use, vital signs, joint mobility, and rehabilitation progress. Blood samples will be taken before surgery and at set intervals afterward to measure inflammation markers. Patient-reported outcomes and satisfaction will be collected up to one year post-surgery. Evaluations will be done in person or by phone if necessary, with the entire follow-up extending through one year after the operation.
CONDITIONS
Brief Title
ACU_Knee: Role of Acupuncture in Knee Prosthetic Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged > 18 years
- Patients capable of providing informed consent
- Unilateral total knee replacement surgery
- Indication for surgery: primary osteoarthritis degeneration
- Surgery performed electively
You will not qualify if you...
- Patients aged < 18 years
- Patients incapable of providing informed consent
- Patients with ASA class > 3
- Pregnant women
- Patients with rheumatoid arthritis or other autoimmune disorders
- Patients with active infection under antibiotic treatment
- Patients on chronic opioid therapy
- Patients on chronic biological drug therapy
- Patients with a history of corticosteroid use in the six months prior to surgery
- Patients with a history of periarticular infiltration in the three months prior to surgery
- Patients in whom loco-regional anesthesia is contraindicated
- Patients in whom NSAID, cortisone, and paracetamol therapy is contraindicated
- Bilateral total knee replacement surgery or prosthetic revision surgeries
- Indication for surgery for causes other than primary osteoarthritis degeneration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 days including surgery and immediate post-operative period
Participants receive a total knee replacement surgery with standard anesthesiological treatment. Those in the acupuncture group will also receive acupuncture and auriculotherapy sessions starting immediately before surgery and continuing at 24, 48, and 72 hours after surgery.
4 visits during the first 4 days (in-person)
Duration - 1 month
Participants are evaluated at 24, 48, 72, and 96 hours after surgery for pain control, joint mobility, rescue analgesic use, vital signs, adverse events, and patient satisfaction. Blood samples for inflammatory biomarkers are collected pre-operatively, at 48 hours, and one month after surgery.
3 blood sample collections and 4 assessment visits (in-person)
Duration - 12 months
Participants undergo outpatient evaluations at 1, 3, 6, and 12 months after surgery to assess pain, joint mobility, analgesic use, functional outcomes, and satisfaction. Some assessments may be conducted by telephone if in-person visits are not possible.
4 outpatient visits and possible telephone assessments
Trial Site Locations
Total: 1 location
1
Fondazione IRCCS Policlinico San Matteo - SC AR3 - Anestesia e Terapia Intensiva Postchirurgica
Pavia, Pavia, Italy, 27100
Actively Recruiting
Research Team
D
Debora Passador, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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