Acupuncture for pain after total knee replacement
ACU_Knee - Role of Acupuncture in Knee Prosthetic Surgery: Analgesia, Functional Outcome and Inflammatory Markers
This project will try acupuncture to reduce short-term pain, opioid use, and inflammation after elective total knee replacement in adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Locations | 1 site (Pavia, Pavia) |
| Trial ID | NCT07123805 on ClinicalTrials.gov |
What this trial studies
Adults having elective unilateral total knee replacement for primary osteoarthritis will receive acupuncture in the perioperative period alongside standard anesthetic care, with clinical assessments and blood tests for inflammatory biomarkers. The primary outcome is pain control at 36–48 hours after surgery, measured together with total opioid consumption, opioid-related side effects, time out of bed, and patient satisfaction. Secondary outcomes include medium- and long-term functional scores and the modulation of systemic inflammatory markers at 1, 3, 6, and 12 months to explore links with chronic pain and joint stiffness. The protocol aims to determine whether acupuncture's analgesic and anti-inflammatory effects lead to faster rehabilitation and lower rates of chronic postoperative pain and stiffness.
Who should consider this trial
Good fit: Adults over 18 undergoing elective unilateral total knee replacement for primary osteoarthritis who can give informed consent, are not on chronic opioid or certain immunomodulatory therapies, and have acceptable anesthetic risk (ASA ≤ 3) are ideal candidates.
Not a fit: Patients with rheumatoid or other autoimmune disease, active infection, chronic opioid therapy, recent corticosteroid or periarticular injections, bilateral or revision procedures, pregnancy, or contraindications to regional anesthesia or NSAIDs/paracetamol are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, acupuncture could reduce acute postoperative pain and opioid needs, speed early mobilization, and lower the risk of chronic pain and joint stiffness after knee replacement.
How similar studies have performed: Previous randomized trials and meta-analyses of acupuncture for postoperative pain have reported mixed results with some modest short-term analgesic and opioid-sparing effects, but high-quality evidence specifically for total knee arthroplasty and long-term outcomes remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged \> 18 years * Patients capable of providing informed consent * Unilateral total knee replacement surgery * Indication for surgery: primary osteoarthritis degeneration * Surgery performed electively Exclusion Criteria: * 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
Where this trial is running
Pavia, Pavia
- Fondazione IRCCS Policlinico San Matteo - SC AR3 - Anestesia e Terapia Intensiva Postchirurgica — Pavia, Pavia, Italy (Recruiting)
Study contacts
- Study coordinator: Debora Passador, MD
- Email: d.passador@smatteo.pv.it
- Phone: +390382502767
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.