Cupping in Osteoarthritis of the Knee

NCT01057043 | Completed

• 1 other identifier: EAI /230/09
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis of the Knee

Keywords

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Western Ontario and McMaster Universities Osteoarthritis (WOMAC) - Score

  4 weeks

Secondary Outcomes (6)

• Western Ontario and McMaster Universities Osteoarthritis (WOMAC) - Scores

  12 weeks

• 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

• Adverse events and serious adverse events

  continously

• Global assessment of efficacy by patients

  week 4 and 12

Study Arms (2)

Waiting list

NO INTERVENTION

In case of acute pain patients may take paracetamol as rescue medication, maximum dosage 2 gram per day.

Cupping

EXPERIMENTAL

In case of acute pain patients may take paracetamol as rescue medication, maximum dosage 2 gram per day.

Device: Pulsatile cupping

Interventions

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.

Also known as: Cupping machine: Puls Reguliertes Vakuum PRV 02; HeVaTec ; registered and certified in Germany [MPG] DIMDI Identifizierungscode DE/0000042259)

Cupping

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Company HeVaTech: collaborator

Study Sites (1)

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

Berlin, State of Berlin, 10117, Germany

Location

Related Publications (1)

• 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.

  PMID: 23057611 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Benno Brinkhaus, Professor, MD

  Charité University Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. MD

Study Record Dates

• First Submitted: January 26, 2010
• First Posted: January 27, 2010
• Study Start: January 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: January 1, 2011
• Last Updated: October 23, 2012

Record last verified: 2012-10

Locations

DE (1)