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Cupping in Osteoarthritis of the Knee

Primary Purpose

Osteoarthritis of the Knee

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Pulsatile cupping
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring Osteoarthritis

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Waiting list

Cupping

Arm Description

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

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

Outcomes

Primary Outcome Measures

Western Ontario and McMaster Universities Osteoarthritis (WOMAC) - Score

Secondary Outcome Measures

Western Ontario and McMaster Universities Osteoarthritis (WOMAC) - Scores
Pain Intensity (Visual Analogue Scale; no pain=0; maximum pain=100 mm)
Quality of Life (SF 36)
Adverse events and serious adverse events
Global assessment of efficacy by patients
Use of rescue medication (paracetamol)

Full Information

First Posted
January 26, 2010
Last Updated
October 22, 2012
Sponsor
Charite University, Berlin, Germany
Collaborators
Company HeVaTech
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1. Study Identification

Unique Protocol Identification Number
NCT01057043
Brief Title
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

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Company HeVaTech

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
Keywords
Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Waiting list
Arm Type
No Intervention
Arm Description
In case of acute pain patients may take paracetamol as rescue medication, maximum dosage 2 gram per day.
Arm Title
Cupping
Arm Type
Experimental
Arm Description
In case of acute pain patients may take paracetamol as rescue medication, maximum dosage 2 gram per day.
Intervention Type
Device
Intervention Name(s)
Pulsatile cupping
Other Intervention Name(s)
Cupping machine: Puls Reguliertes Vakuum PRV 02; HeVaTec ; registered and certified in Germany [MPG] DIMDI Identifizierungscode DE/0000042259)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) - Score
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) - Scores
Time Frame
12 weeks
Title
Pain Intensity (Visual Analogue Scale; no pain=0; maximum pain=100 mm)
Time Frame
week 4 and 12
Title
Quality of Life (SF 36)
Time Frame
4 and 12 weeks
Title
Adverse events and serious adverse events
Time Frame
continously
Title
Global assessment of efficacy by patients
Time Frame
week 4 and 12
Title
Use of rescue medication (paracetamol)
Time Frame
weeks 1-4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benno Brinkhaus, Professor, MD
Organizational Affiliation
Charité University Berlin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institiute for Social Medicine, Epidemiology and Health Economy, Charité University Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
23057611
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.
Results Reference
derived

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Cupping in Osteoarthritis of the Knee

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