Association of Acupuncture and Cupping in Advanced Knee Osteoarthritis

May 14, 2021 updated by: University of Sao Paulo General Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Sao Paulo
      • São Paulo, Sao Paulo, Brazil
        • USaoPauloGH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: A- Placebo
Sham Acupuncture and Sham Cupping
Procedure: Acupuncture
20 min of Acupuncture section follow by 10 min of cupping around the knee
Other Names:
  • Cupping
Active Comparator: B -Cupping
Sham Acupuncture and Real Cupping
Procedure: Acupuncture
20 min of Acupuncture section follow by 10 min of cupping around the knee
Other Names:
  • Cupping
Active Comparator: C - Acupuncture
Real Acupuncture and Sham Cupping
Procedure: Acupuncture
20 min of Acupuncture section follow by 10 min of cupping around the knee
Other Names:
  • Cupping
Active Comparator: D - Acupuncture + Cupping
Real Acupuncture and Real Cupping
Procedure: Acupuncture
20 min of Acupuncture section follow by 10 min of cupping around the knee
Other Names:
  • Cupping

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain improvement: Western Ontario and McMaster Universities Osteoarthritis (WOMAC - Pain section)
Time Frame: Change on Woman-Pain score from Baseline to 5 weeks
Womac-Pain section. Score: 0 (no pain) to 20 (worse condition)
Change on Woman-Pain score from Baseline to 5 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Chin Lin, University of Sao Paulo General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2018

Primary Completion (Actual)

October 30, 2019

Study Completion (Actual)

May 30, 2020

Study Registration Dates

First Submitted

November 12, 2019

First Submitted That Met QC Criteria

November 18, 2019

First Posted (Actual)

November 19, 2019

Study Record Updates

Last Update Posted (Actual)

May 17, 2021

Last Update Submitted That Met QC Criteria

May 14, 2021

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Acupuncture in KOA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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