Clinical trial NCT04168593: Association of Acupuncture and Cupping in Advanced Knee Osteoarthritis
Official title: Randomized Controlled Trial of the Use of Acupuncture and Cupping in Patients Awaiting Total Knee Arthroplasty (TKA) Due to Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Pain, Chronic
Keywords: Acupuncture
Cupping
Osteoarthritis
Pain
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2019-11-19
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Given the lack of studies in the literature associating the use of acupuncture and sliding suction cup in patients with advanced knee osteoarthritis, the objective of this study is to evaluate the benefits of this association in patients of the Institute of Orthopedics and Traumatology outpatient clinic of the University of São Paulo while awaiting surgical treatment of knee osteoarthritis as a method of pain relief, limb function improvement and quality of life.

Detailed description: 120 patients with indications for surgical knee treatment from IOT-HCFMUSP will be invited to participate in the project. Inclusion applications and those who agree to sign a free and informed consent form (IC) will be included.

During the period of inclusion of patients, will be clarified regarding the application and evaluation methods that will be used through consultation and initial medical evaluation. Then, the included patients are randomized into four existing groups:

Group A - Acupuncture Sham + Cupping Sham; Group B - Sham Acupuncture + Real Cupping; Group C - Real Acupuncture + Sham Cupping; Group D - Real Acupuncture + Real Cupping.

Eligibility criteria: Inclusion Criteria:

* patients with a diagnosis of knee osteoarthritis
* WOMAC-Pain greater than or equal to 15 points.

Exclusion Criteria:

* advanced degenerative central neuropathy (Parkinson's, Alzheimer's)
* diabetic peripheral neuropathy
* stroke sequela
* history of digestive bleeding
* chronic renal failure
* renal failure
* heart failure
* fibromyalgia
* rheumatoid arthritis
* SLE
* severe depression
* psychiatric disorders
* concomitance with hip arthritis

Primary outcomes:
measure: WOMAC - Pain
timeFrame: value collected at 5 week
measure: VAS
timeFrame: Value collected at 5 weeks
Secondary outcomes:
measure: Analgesic Consumption
timeFrame: Number of Participants with reduction in the use of pain medications after protocol (at 5 week)
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: USaoPauloGH
state: Sao Paulo
Study officials:
affiliation: University of Sao Paulo General Hospital
name: Chin Lin
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kraus VB, Blanco FJ, Englund M, Karsdal MA, Lohmander LS. Call for standardized definitions of osteoarthritis and risk stratification for clinical trials and clinical use. Osteoarthritis Cartilage. 2015 Aug;23(8):1233-41. doi: 10.1016/j.joca.2015.03.036. Epub 2015 Apr 9.
citation: Corbett MS, Rice SJ, Madurasinghe V, Slack R, Fayter DA, Harden M, Sutton AJ, Macpherson H, Woolacott NF. Acupuncture and other physical treatments for the relief of pain due to osteoarthritis of the knee: network meta-analysis. Osteoarthritis Cartilage. 2013 Sep;21(9):1290-8. doi: 10.1016/j.joca.2013.05.007.