Association of Acupuncture and Cupping in Advanced Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Randomized Controlled Trial of the Use of Acupuncture and Cupping in Patients Awaiting Total Knee Arthroplasty (TKA) Due to Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04168593
• Other study ID #: Acupuncture in KOA
• Status: Completed
• Phase: N/A
• Start date: September 12, 2018
• Est. completion date: May 30, 2020

Study information

• Verified date: November 2019
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 30, 2020
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Pain, Chronic

Intervention

Procedure:
• Acupuncture
20 min of Acupuncture section follow by 10 min of cupping around the knee

Locations

Country	Name	City	State
Brazil	USaoPauloGH	São Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain improvement: Western Ontario and McMaster Universities Osteoarthritis (WOMAC - Pain section)	Womac-Pain section. Score: 0 (no pain) to 20 (worse condition)	Change on Woman-Pain score from Baseline to 5 weeks
Secondary	Function improvement: Western Ontario and McMaster Universities Osteoarthritis (WOMAC - Function section)	Womac- Function section. Score 0 (no limitation) to 68 (worse condition)	Change on Woman-Function score from Baseline to 5 weeks
Secondary	analgesic consumption	number of pills per day	If is there any reduction analgesic use from Baseline to 5 weeks