Clinical trial NCT01057043: Cupping in Osteoarthritis of the Knee
Official title: Randomised Controlled Clinical Trial on Pulsatile Cupping in Patients With Osteoarthritis of the Knee.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis of the Knee
Keywords: Osteoarthritis
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Company HeVaTech
First posted: 2010-01-27
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis (WOMAC) - Score
timeFrame: 4 weeks
Secondary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis (WOMAC) - Scores
timeFrame: 12 weeks
measure: Pain Intensity (Visual Analogue Scale; no pain=0; maximum pain=100 mm)
timeFrame: week 4 and 12
measure: Quality of Life (SF 36)
timeFrame: 4 and 12 weeks
measure: Adverse events and serious adverse events
timeFrame: continously
measure: Global assessment of efficacy by patients
timeFrame: week 4 and 12
measure: Use of rescue medication (paracetamol)
timeFrame: weeks 1-4
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Institiute for Social Medicine, Epidemiology and Health Economy, Charité University Berlin
Study officials:
affiliation: Charité University Berlin
name: Benno Brinkhaus, Professor, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Teut M, Kaiser S, Ortiz M, Roll S, Binting S, Willich SN, Brinkhaus B. Pulsatile dry cupping in patients with osteoarthritis of the knee - a randomized controlled exploratory trial. BMC Complement Altern Med. 2012 Oct 12;12:184. doi: 10.1186/1472-6882-12-184.