Cupping in Osteoarthritis of the Knee

Not Applicable

Completed

• Conditions: Osteoarthritis of the Knee
• Interventions: Device: Pulsatile cupping

• Registration Number: NCT01057043
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-26
• Study First Submitted QC: 2010-01-26
• Study First Posted: 2010-01-27
• Primary Completion: 2010-07
• Study Completion: 2011-01
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-22
• Last Update Posted: 2012-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cupping	Pulsatile cupping	In case of acute pain patients may take paracetamol as rescue medication, maximum dosage 2 gram per day.

Primary Outcome Measures

Name	Time	Method
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) - Score	4 weeks

Secondary Outcome Measures

Name	Time	Method
Use of rescue medication (paracetamol)	weeks 1-4
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

Trial Locations

Locations (1)

Institiute for Social Medicine, Epidemiology and Health Economy, Charité University Berlin; 🇩🇪 Berlin, Germany