Association of Acupuncture and Cupping in Advanced Knee Osteoarthritis

NCT ID: NCT04168593

Last Updated: 2025-03-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-12

Study Completion Date

2020-05-30

Brief Summary

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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

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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.

Conditions

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Knee Osteoarthritis Pain, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A- Placebo

Sham Acupuncture and Sham Cupping

Group Type SHAM_COMPARATOR

Acupuncture

Intervention Type PROCEDURE

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

B -Cupping

Sham Acupuncture and Real Cupping

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type PROCEDURE

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

C - Acupuncture

Real Acupuncture and Sham Cupping

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type PROCEDURE

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

D - Acupuncture + Cupping

Real Acupuncture and Real Cupping

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type PROCEDURE

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

Interventions

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Acupuncture

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

Intervention Type PROCEDURE

Other Intervention Names

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Cupping

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chin Lin

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo General Hospital

Locations

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USaoPauloGH

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 25865392 (View on PubMed)

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.

Reference Type RESULT
PMID: 23973143 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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Acupuncture in KOA

Identifier Type: -

Identifier Source: org_study_id

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