Association of Acupuncture and Cupping in Advanced Knee Osteoarthritis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Knee Osteoarthritis, Pain, Chronic

Intervention / Treatment
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* Procedure: Acupuncture


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: A- Placebo<br>Sham Acupuncture and Sham Cupping | Procedure: Acupuncture<br>* 20 min of Acupuncture section follow by 10 min of cupping around the knee<br>* Other names: Cupping;|
| Active Comparator: B -Cupping<br>Sham Acupuncture and Real Cupping | Procedure: Acupuncture<br>* 20 min of Acupuncture section follow by 10 min of cupping around the knee<br>* Other names: Cupping;|
| Active Comparator: C - Acupuncture<br>Real Acupuncture and Sham Cupping | Procedure: Acupuncture<br>* 20 min of Acupuncture section follow by 10 min of cupping around the knee<br>* Other names: Cupping;|
| Active Comparator: D - Acupuncture + Cupping<br>Real Acupuncture and Real Cupping | Procedure: Acupuncture<br>* 20 min of Acupuncture section follow by 10 min of cupping around the knee<br>* Other names: Cupping;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain improvement: Western Ontario and McMaster Universities Osteoarthritis (WOMAC - Pain section) | Womac-Pain section. Score: 0 (no pain) to 20 (worse condition) | Change on Woman-Pain score from Baseline to 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Function improvement: Western Ontario and McMaster Universities Osteoarthritis (WOMAC - Function section) | Womac- Function section. Score 0 (no limitation) to 68 (worse condition) | Change on Woman-Function score from Baseline to 5 weeks | 
| analgesic consumption | number of pills per day | If is there any reduction analgesic use from Baseline to 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture, Cupping, Osteoarthritis, Pain