Randomized Controlled Trial of the Use of Acupuncture and Cupping in Patients Awaiting Total Knee Arthroplasty (TKA) Due to Knee Osteoarthritis
Phase: NA
Conditions: Knee Osteoarthritis, Pain, Chronic
Sponsor: University of Sao Paulo General Hospital

São Paulo, Jan 18th, 2017 
 
Association of Acupuncture and Cupping in Advanced Knee Osteoarthritis 
NCT 04168593 
 
 
Study protocol 
 
120 patients waiting for surgical treatment from the knee outpatient clinic of the IOT-
HCFMUSP were invited to participate in the project. Inclusion and exclusion criteria were 
applied, and those who accepted signed an informed consent form (ICF), and later 
allocated to the existing groups: A. Group A – Acupuncture Sham + Cupping Sham; B. 
Group B - Acupuncture Sham+ True Cupping; C. Group C - True Acupuncture + Cupping 
Sham; D. Group D – True Acupuncture + True Cupping. The Western Ontario and 
McMaster Osteoarthritis Index (WOMAC) questionnaire was used, which assesses pain, 
stiffness and functionality, and the number of analgesics and/or anti-inflammatory drugs 
used during the research period was also recorded. All the records were collected on the 
first interview and after 5 weeks treatment. 
 
Group A – Acupuncture Sham + Cupping Sham 
 
Sham acupuncture: Placement of placebo "dagger" needles. The needle tip, when 
touching the patient's skin, retracts into itself without puncturing the skin. Application 
locations: LI11, SP9, SP10, LR8, GB34, ST34, Ex-LE5. Running time of 20 minutes. 
Sham cupping: after each acupuncture session (Sham or True), the respective needles 
were removed, and acrylic suction cups were placed over the region where the needles 
were, attached to a strip (micropore) without exerting any negative pressure or 
movement. Application time of 10 minutes. 
 
Group B – Acupuncture Sham+ True Cupping 
Sham Acupuncture 20 min follow by 10 min of cupping around the knee 
 
Group C – True Acupuncture + Cupping Sham 
20 min of Acupuncture section follow by 10 min of Sham cupping around the knee 
 
Group D – True Acupuncture + True Cupping 
20 min of Acupuncture section follow by 10 min of cupping around the knee