Association of Acupuncture and Cupping in Advanced Knee Osteoarthritis

Not Applicable

Completed

• Conditions: Pain, Chronic; Knee Osteoarthritis
• Interventions: Procedure: Acupuncture

• Registration Number: NCT04168593
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-09-12
• Primary Completion: 2019-10-30
• Status Verified: 2019-11
• Study First Submitted: 2019-11-12
• Study First Submitted QC: 2019-11-18
• Study First Posted: 2019-11-19
• Study Completion: 2020-05-30
• Results First Submitted: 2022-12-20
• Results First Submitted QC: 2025-03-26
• Last Update Submitted: 2025-03-26
• Results First Posted: 2025-03-27
• Last Update Posted: 2025-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
A- Placebo	Acupuncture	Sham Acupuncture and Sham Cupping
C - Acupuncture	Acupuncture	Real Acupuncture and Sham Cupping
D - Acupuncture + Cupping	Acupuncture	Real Acupuncture and Real Cupping
B -Cupping	Acupuncture	Sham Acupuncture and Real Cupping

Primary Outcome Measures

Name	Time	Method
WOMAC - Pain	value collected at 5 week	Western Ontario and McMaster Universities Osteoarthritis Womac-Pain section. Score: 0 (no pain) to 20 (worse condition)
VAS	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 Outcome Measures

Name	Time	Method
Analgesic Consumption	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).

Trial Locations

Locations (1)

USaoPauloGH; 🇧🇷 São Paulo, Sao Paulo, Brazil