Cupping in Osteoarthritis of the Knee

This study has been completed.
Sponsor:
Collaborator:
Company HeVaTech
Information provided by (Responsible Party):
Benno Brinkhaus, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01057043
First received: January 26, 2010
Last updated: October 22, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Osteoarthritis of the Knee
Device: Pulsatile cupping

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomised Controlled Clinical Trial on Pulsatile Cupping in Patients With Osteoarthritis of the Knee.

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Western Ontario and McMaster Universities Osteoarthritis (WOMAC) - Score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

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

Enrollment: 40
Study Start Date: January 2010
Study Completion Date: January 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Cupping machine: Puls Reguliertes Vakuum PRV 02; HeVaTec ; registered and certified in Germany [MPG] DIMDI Identifizierungscode DE/0000042259)

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01057043

Locations
Germany
Institiute for Social Medicine, Epidemiology and Health Economy, Charité University Berlin
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Company HeVaTech
Investigators
Principal Investigator: Benno Brinkhaus, Professor, MD Charité University Berlin
  More Information

Additional Information:
No publications provided by Charite University, Berlin, Germany

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Benno Brinkhaus, Prof. MD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01057043     History of Changes
Other Study ID Numbers: EAI /230/09
Study First Received: January 26, 2010
Last Updated: October 22, 2012
Health Authority: Germany: Charité University, Berlin

Keywords provided by Charite University, Berlin, Germany:
Osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 22, 2014