Cupping in Osteoarthritis of the Knee

Study Overview
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Brief Summary
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The purpose of this exploratory randomised trial is to study the effect of pulsatile cupping in osteoarthritis of the knee compared to waiting list control.

Detailed Description
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Cupping is a traditional therapy in many cultures of the world and is used to treat osteoarthritis of the knee. In this randomised trial we want to study the effect of pulsatile cupping in osteoarthritis of the knee compared to waiting list control. Pulsatile cupping is administered by a special cupping machine (HeVaTec) with silicone cupping glasses to the knee joint. Pulsatile pressure is generated by a pump that generates vacuum.

Official Title
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Randomised Controlled Clinical Trial on Pulsatile Cupping in Patients With Osteoarthritis of the Knee.

Conditions
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Osteoarthritis of the Knee

Intervention / Treatment
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* Device: Pulsatile cupping


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Osteoarthritis of the knee according ACR-criteria X-ray classification minimum Kellgren-Lawrence criteria grade 2 Pain Intensity > 40 mm VAS Only therapy with NSAIDin the last 4 weeks Informed consent Exclusion Criteria: Use of anticoagulants (Phenprocoumon, Heparin) Coagulopathy Cupping in the last 12 months Intraarticular injection of corticosteroids or NSAID into the knee joint in the last 4 months Use of systemic corticosteroids in the last 4 weeks Physical therapy, leeches or acupuncture in the last 4 months Other CAM therapies for the osteoarthritis in the last 4 weeks Arthroscopy of the knee joint in the last 12 months Paracetamol allergy or intolerance

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Waiting list<br>In case of acute pain patients may take paracetamol as rescue medication, maximum dosage 2 gram per day. | |
| Experimental: Cupping<br>In case of acute pain patients may take paracetamol as rescue medication, maximum dosage 2 gram per day. | Device: Pulsatile cupping<br>* 8 sessions cupping in 4 weeks, administered by a cupping machine. Cupping is administered in each session for 15 minutes with silicon cupping glasses to the knee (osteoarthritis) and the lower back.<br>* Other names: Cupping machine: Puls Reguliertes Vakuum PRV 02; HeVaTec ; registered and certified in Germany [MPG] DIMDI Identifizierungscode DE/0000042259);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster Universities Osteoarthritis (WOMAC) - Score |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster Universities Osteoarthritis (WOMAC) - Scores |  | 12 weeks | 
| Pain Intensity (Visual Analogue Scale; no pain=0; maximum pain=100 mm) |  | week 4 and 12 | 
| Quality of Life (SF 36) |  | 4 and 12 weeks | 
| Adverse events and serious adverse events |  | continously | 
| Global assessment of efficacy by patients |  | week 4 and 12 | 
| Use of rescue medication (paracetamol) |  | weeks 1-4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis