search
Back to results

Association of Acupuncture and Cupping in Advanced Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis, Pain, Chronic

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Acupuncture, Cupping, Osteoarthritis, Pain

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • USaoPauloGH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Sham Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

A- Placebo

B -Cupping

C - Acupuncture

D - Acupuncture + Cupping

Arm Description

Sham Acupuncture and Sham Cupping

Sham Acupuncture and Real Cupping

Real Acupuncture and Sham Cupping

Real Acupuncture and Real Cupping

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Function improvement: Western Ontario and McMaster Universities Osteoarthritis (WOMAC - Function section)
Womac- Function section. Score 0 (no limitation) to 68 (worse condition)
analgesic consumption
number of pills per day

Full Information

First Posted
November 12, 2019
Last Updated
May 14, 2021
Sponsor
University of Sao Paulo General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04168593
Brief Title
Association of Acupuncture and Cupping in Advanced Knee Osteoarthritis
Official Title
Randomized Controlled Trial of the Use of Acupuncture and Cupping in Patients Awaiting Total Knee Arthroplasty (TKA) Due to Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
September 12, 2018 (Actual)
Primary Completion Date
October 30, 2019 (Actual)
Study Completion Date
May 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Pain, Chronic
Keywords
Acupuncture, Cupping, Osteoarthritis, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A- Placebo
Arm Type
Sham Comparator
Arm Description
Sham Acupuncture and Sham Cupping
Arm Title
B -Cupping
Arm Type
Active Comparator
Arm Description
Sham Acupuncture and Real Cupping
Arm Title
C - Acupuncture
Arm Type
Active Comparator
Arm Description
Real Acupuncture and Sham Cupping
Arm Title
D - Acupuncture + Cupping
Arm Type
Active Comparator
Arm Description
Real Acupuncture and Real Cupping
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Other Intervention Name(s)
Cupping
Intervention Description
20 min of Acupuncture section follow by 10 min of cupping around the knee
Primary Outcome Measure Information:
Title
Pain improvement: Western Ontario and McMaster Universities Osteoarthritis (WOMAC - Pain section)
Description
Womac-Pain section. Score: 0 (no pain) to 20 (worse condition)
Time Frame
Change on Woman-Pain score from Baseline to 5 weeks
Secondary Outcome Measure Information:
Title
Function improvement: Western Ontario and McMaster Universities Osteoarthritis (WOMAC - Function section)
Description
Womac- Function section. Score 0 (no limitation) to 68 (worse condition)
Time Frame
Change on Woman-Function score from Baseline to 5 weeks
Title
analgesic consumption
Description
number of pills per day
Time Frame
If is there any reduction analgesic use from Baseline to 5 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chin Lin
Organizational Affiliation
University of Sao Paulo General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
USaoPauloGH
City
São Paulo
State/Province
Sao Paulo
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Association of Acupuncture and Cupping in Advanced Knee Osteoarthritis

We'll reach out to this number within 24 hrs