Osteoarthritis of the Knee
Conditions
Keywords
Osteoarthritis
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.
Interventions
DEVICEPulsatile 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.
Sponsors
Company HeVaTech
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Western Ontario and McMaster Universities Osteoarthritis (WOMAC) - Score | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Western Ontario and McMaster Universities Osteoarthritis (WOMAC) - Scores | 12 weeks |
| Global assessment of efficacy by patients | week 4 and 12 |
| Use of rescue medication (paracetamol) | weeks 1-4 |
| Adverse events and serious adverse events | continously |
Countries
Germany
Outcome results
None listed