Cupping in Osteoarthritis of the Knee

Osteoarthritis of the Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01057043
• Other study ID #: EAI /230/09
• Status: Completed
• Phase: N/A
• First received: January 26, 2010
• Last updated: October 22, 2012
• Start date: January 2010
• Est. completion date: January 2011

Study information

• Verified date: October 2012
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Charité University, Berlin
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
Germany	Institiute for Social Medicine, Epidemiology and Health Economy, Charité University Berlin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Company HeVaTech

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Western Ontario and McMaster Universities Osteoarthritis (WOMAC) - Score		4 weeks	No
Secondary	Western Ontario and McMaster Universities Osteoarthritis (WOMAC) - Scores		12 weeks	No
Secondary	Pain Intensity (Visual Analogue Scale; no pain=0; maximum pain=100 mm)		week 4 and 12	No
Secondary	Quality of Life (SF 36)		4 and 12 weeks	No
Secondary	Adverse events and serious adverse events		continously	Yes
Secondary	Global assessment of efficacy by patients		week 4 and 12	No
Secondary	Use of rescue medication (paracetamol)		weeks 1-4	No