Study Results
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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COMPLETED
NA
110 participants
INTERVENTIONAL
2014-03-31
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
TREATMENT
SINGLE
Study Groups
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Pulsatile Cupping
Pulsatile Cupping
8 cupping sessions (each 8 minutes) in 4 weeks (-150 to -350 mbar), interval 2 seconds.
Paracetamol on demand as rescue medication (maximum dosage 4 x500 mg/day)
Minimal Cupping
Minimal Cupping
8 cupping sessions (each 8 minutes) in 4 weeks witth (-60 to -70 mbar). Paracetamol on demand as rescue medication (maximum dosage 4 x500 mg/day).
No Intervention
Waiting list
No interventions assigned to this group
Interventions
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Pulsatile Cupping
8 cupping sessions (each 8 minutes) in 4 weeks (-150 to -350 mbar), interval 2 seconds.
Paracetamol on demand as rescue medication (maximum dosage 4 x500 mg/day)
Minimal Cupping
8 cupping sessions (each 8 minutes) in 4 weeks witth (-60 to -70 mbar). Paracetamol on demand as rescue medication (maximum dosage 4 x500 mg/day).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Chronic low back pain (disease duration \> 3 months)
* Pain intensity on visual analogue scale at inclusion \> 40 mm (0-100 mm scale)
* Only pharmacological treatment with NSAID or no treatment in the last 4 weeks
* Undersigned informed consent form
Exclusion Criteria
* Coagulopathy
* Cupping in the last 6 weeks
* Other CAM therapies in the last 12 weeks (e.g. acupuncture)
* Physical therapy in the last 12 weeks (e.g. massage, osteopathy)
* participation in another study in the last 3 months
* Paracetamol allergy or intolerance
* Pathological neurological symptoms such as muscular paralysis or paraesthesia due to spinal disc herniation or other causes
* Known renal and / or hepatic diseases
* Intake of central nervous system-acting analgesics in the last 6 weeks
* Applying for early retirement due to low back pain
* Severe disease that does not allow participation
* No undersigned informed consent form
18 Years
65 Years
ALL
No
Sponsors
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HeVaTech GmbH
UNKNOWN
Charite University, Berlin, Germany
OTHER
Responsible Party
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Benno Brinkhaus
Prof.
Principal Investigators
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Benno Brinkhaus, Professor
Role: PRINCIPAL_INVESTIGATOR
Charite University, Berlin, Germany
Locations
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Charité Universitätsmedizin Berlin
Berlin, , Germany
Countries
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References
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Teut M, Ullmann A, Ortiz M, Rotter G, Binting S, Cree M, Lotz F, Roll S, Brinkhaus B. Pulsatile dry cupping in chronic low back pain - a randomized three-armed controlled clinical trial. BMC Complement Altern Med. 2018 Apr 2;18(1):115. doi: 10.1186/s12906-018-2187-8.
Other Identifiers
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Cupping-LBP
Identifier Type: -
Identifier Source: org_study_id
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