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Association of Acupuncture and Cupping in Advanced Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT04168593
Recruitment Status : Completed
First Posted : November 19, 2019
Last Update Posted : May 17, 2021
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Pain, Chronic Procedure: Acupuncture Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of the Use of Acupuncture and Cupping in Patients Awaiting Total Knee Arthroplasty (TKA) Due to Knee Osteoarthritis
Actual Study Start Date : September 12, 2018
Actual Primary Completion Date : October 30, 2019
Actual Study Completion Date : May 30, 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: 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 Name: Cupping




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. analgesic consumption [ Time Frame: If is there any reduction analgesic use from Baseline to 5 weeks ]
    number of pills per day



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04168593


Locations
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Brazil
USaoPauloGH
São Paulo, Sao Paulo, Brazil
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Chin Lin University of Sao Paulo General Hospital
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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT04168593    
Other Study ID Numbers: Acupuncture in KOA
First Posted: November 19, 2019    Key Record Dates
Last Update Posted: May 17, 2021
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Sao Paulo General Hospital:
Acupuncture
Cupping
Osteoarthritis
Pain
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Chronic Pain
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pain
Neurologic Manifestations