Osteoarthritis of the KneeNCT01057043
Cupping in Osteoarthritis of the Knee
A study testing Pulsatile cupping in people with Osteoarthritis of the Knee, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Pulsatile cupping
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2010to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institiute for Social Medicine, Epidemiology and Health Economy, Charité University Berlin
Berlin, State of Berlin, 10117
About this study
Official title: Randomised Controlled Clinical Trial on Pulsatile Cupping in Patients With Osteoarthritis of the Knee.
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.
Read the 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.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Pulsatile cupping
- Keywords
- Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsatile cuppingDevice
Also called Cupping machine: Puls Reguliertes Vakuum PRV 02; HeVaTec ; registered and certified in Germany [MPG] DIMDI Identifizierungscode DE/0000042259)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Pulsatile cupping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) - Score
Measured: 4 weeks
Secondary outcomes (6)
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) - Scores
Measured: 12 weeks
Pain Intensity (Visual Analogue Scale; no pain=0; maximum pain=100 mm)
Measured: week 4 and 12
Quality of Life (SF 36)
Measured: 4 and 12 weeks
Adverse events and serious adverse events
Measured: continously
Global assessment of efficacy by patients
Measured: week 4 and 12
Use of rescue medication (paracetamol)
Measured: weeks 1-4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionJul 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis of the KneeStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Company HeVaTech
- Responsible party
- Principal investigator, Benno Brinkhaus, Charite University, Berlin, Germany
- Investigators
- Benno Brinkhaus, Professor, MD, Principal investigator, Charité University Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01057043
- Sponsor's protocol ID
- EAI /230/09
- Status last verified
- Oct 2012
- First submitted
- 26 Jan 2010
- Last updated
- 23 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23057611
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Clinical Trial on Pulsatile Cupping in Patients With Osteoarthritis of the Knee.
- ClinicalTrials.gov ID
- NCT01057043
- Acronym / sponsor ID
- EAI /230/09
- Conditions
- Osteoarthritis of the Knee
- Keywords
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Company HeVaTech
- Study start
- Jan 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 27 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Waiting list | No intervention | –In case of acute pain patients may take paracetamol as rescue medication, maximum dosage 2 gram per day. |
| Cupping | Experimental | Device: Pulsatile cuppingIn case of acute pain patients may take paracetamol as rescue medication, maximum dosage 2 gram per day. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsatile cuppingAlso: Cupping machine: Puls Reguliertes Vakuum PRV 02; HeVaTec ; registered and certified in Germany [MPG] DIMDI Identifizierungscode DE/0000042259)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. | Device | Cupping |
Primary outcome
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) - Score
Time frame: 4 weeks
6 secondary outcomes
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) - Scores
Time frame: 12 weeks
Pain Intensity (Visual Analogue Scale; no pain=0; maximum pain=100 mm)
Time frame: week 4 and 12
Quality of Life (SF 36)
Time frame: 4 and 12 weeks
Adverse events and serious adverse events
Time frame: continously
Global assessment of efficacy by patients
Time frame: week 4 and 12
Use of rescue medication (paracetamol)
Time frame: weeks 1-4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2012.
- Derived from this study: PubMed 23057611Teut 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benno Brinkhaus, Professor, MD principal investigator
Charité University Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsatile cupping in people with Osteoarthritis of the Knee, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) - Score (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01057043, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2012.