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Cupping in Osteoarthritis of the Knee

NCT ID: NCT01057043

Last Updated: 2012-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-01-31

Brief Summary

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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

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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.

Conditions

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Osteoarthritis of the Knee

Keywords

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Waiting list

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Cupping

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

Group Type EXPERIMENTAL

Pulsatile cupping

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Company HeVaTech

UNKNOWN

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Benno Brinkhaus

Prof. MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Benno Brinkhaus, Professor, MD

Role: PRINCIPAL_INVESTIGATOR

Charité University Berlin

Locations

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

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 23057611 (View on PubMed)

Other Identifiers

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EAI /230/09

Identifier Type: -

Identifier Source: org_study_id