NCT04168593

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 12, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 19, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

March 27, 2025

Completed
Last Updated

March 27, 2025

Status Verified

November 1, 2019

Enrollment Period

1.1 years

First QC Date

November 12, 2019

Results QC Date

December 20, 2022

Last Update Submit

March 26, 2025

Conditions

Knee OsteoarthritisPain, Chronic

Keywords

AcupunctureCuppingOsteoarthritisPain

Outcome Measures

Primary Outcomes (2)

  • WOMAC - Pain

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

    value collected at 5 week

  • VAS

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

    Value collected at 5 weeks

Secondary Outcomes (1)

  • Analgesic Consumption

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

Study Arms (4)

A- Placebo

SHAM COMPARATOR

Sham Acupuncture and Sham Cupping

Procedure: Acupuncture

B -Cupping

ACTIVE COMPARATOR

Sham Acupuncture and Real Cupping

Procedure: Acupuncture

C - Acupuncture

ACTIVE COMPARATOR

Real Acupuncture and Sham Cupping

Procedure: Acupuncture

D - Acupuncture + Cupping

ACTIVE COMPARATOR

Real Acupuncture and Real Cupping

Procedure: Acupuncture

Interventions

AcupuncturePROCEDURE

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

Also known as: Cupping
A- PlaceboB -CuppingC - AcupunctureD - Acupuncture + Cupping

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with a diagnosis of knee osteoarthritis
  • WOMAC-Pain greater than or equal to 15 points.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USaoPauloGH

São Paulo, São Paulo, Brazil

Location

Related Publications (2)

  • 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.

    PMID: 25865392BACKGROUND

  • 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.

    PMID: 23973143RESULT

MeSH Terms

Conditions

Osteoarthritis, KneeChronic PainOsteoarthritisPain

Interventions

Acupuncture TherapyCupping Therapy

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Results Point of Contact

Title
Andre Wan Wen Tsai
Organization
USaoPauloGH
tsai.andre@gmail.com
5511981456449

Study Officials

  • Chin Lin

    University of Sao Paulo General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2019

First Posted

November 19, 2019

Study Start

September 12, 2018

Primary Completion

October 30, 2019

Study Completion

May 30, 2020

Last Updated

March 27, 2025

Results First Posted

March 27, 2025

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

these data are totally confidencial and unique to this protocol

Locations

BR(1)