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Completed

NCT Number: NCT01057043

Cupping in 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.

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Key information

Conditions

Osteoarthritis of the Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Berlin, State of Berlin, 10117, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulsatile Cupping

Device

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)

Primary outcomes

  1. Western Ontario and McMaster Universities Osteoarthritis (WOMAC) - Score

    Time frame: 4 weeks

Secondary outcomes

  1. Western Ontario and McMaster Universities Osteoarthritis (WOMAC) - Scores

    Time frame: 12 weeks

  2. Pain Intensity (Visual Analogue Scale; no pain=0; maximum pain=100 mm)

    Time frame: week 4 and 12

  3. Quality of Life (SF 36)

    Time frame: 4 and 12 weeks

  4. Adverse events and serious adverse events

    Time frame: continously

  5. Global assessment of efficacy by patients

    Time frame: week 4 and 12

  6. Use of rescue medication (paracetamol)

    Time frame: weeks 1-4

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Company HeVaTech

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Jan 27, 2010
Registry last updated
Oct 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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