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Association of Acupuncture and Cupping in Advanced Knee Osteoarthritis

U

University of Sao Paulo General Hospital

Status

Completed

Conditions

Pain, Chronic
Knee Osteoarthritis

Treatments

Procedure: Acupuncture

Study type

Interventional

Funder types

Other

Identifiers

NCT04168593
Acupuncture in KOA

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Double Blind

120 participants in 4 patient groups

A- Placebo
Sham Comparator group
Description:
Sham Acupuncture and Sham Cupping
Treatment:
Procedure: Acupuncture
B -Cupping
Active Comparator group
Description:
Sham Acupuncture and Real Cupping
Treatment:
Procedure: Acupuncture
C - Acupuncture
Active Comparator group
Description:
Real Acupuncture and Sham Cupping
Treatment:
Procedure: Acupuncture
D - Acupuncture + Cupping
Active Comparator group
Description:
Real Acupuncture and Real Cupping
Treatment:
Procedure: Acupuncture

Trial documents
3

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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