Cupping in Osteoarthritis of the Knee

October 22, 2012 updated by: Benno Brinkhaus, Charite University, Berlin, Germany

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Institiute for Social Medicine, Epidemiology and Health Economy, Charité University Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Waiting list
In case of acute pain patients may take paracetamol as rescue medication, maximum dosage 2 gram per day.
Experimental: Cupping
In case of acute pain patients may take paracetamol as rescue medication, maximum dosage 2 gram per day.
Device: Pulsatile cupping
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.
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?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

Company HeVaTech

Investigators

  • Principal Investigator: Benno Brinkhaus, Professor, MD, Charité University Berlin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

January 26, 2010

First Submitted That Met QC Criteria

January 26, 2010

First Posted (Estimate)

January 27, 2010

Study Record Updates

Last Update Posted (Estimate)

October 23, 2012

Last Update Submitted That Met QC Criteria

October 22, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EAI /230/09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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