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Completed

NCT Number: NCT04168593

Association of Acupuncture and Cupping in Advanced 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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Chronic Pain Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Osteoarthritis, Knee Pain Pain, Chronic Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USaoPauloGH

São Paulo, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupuncture

Procedure

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

Other names: Cupping

Primary outcomes

  1. WOMAC - Pain

    Time frame: value collected at 5 week

    Western Ontario and McMaster Universities Osteoarthritis Womac-Pain section. Score: 0 (no pain) to 20 (worse condition)

  2. VAS

    Time frame: Value collected at 5 weeks

    Intensity of pain 0-100 mm (0 corresponds to a better condition, otherwise, 100 correspond to a worst condition of pain)

Secondary outcomes

  1. Analgesic Consumption

    Time frame: Number of Participants with reduction in the use of pain medications after protocol (at 5 week)

    number of pills per day For each group, those who had a reduction in the use of pain medications (analgesics and/or anti-inflammatory drugs) we described as Y (yes), and those who maintained or even increased the amount or simply did not return such information we described as N (no).

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Nov 19, 2019
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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