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| Name | Class |
|---|---|
| HeVaTech GmbH | UNKNOWN |
The purpose of this study is to determine whether pulsatile cupping with a cupping device is effective in the treatment of patients with chronic low back pain compared to no cupping or to minimal cupping.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulsatile Cupping | Active Comparator |
| |
| Minimal Cupping | Active Comparator |
| |
| No Intervention | No Intervention | Waiting list |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsatile Cupping | Device | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Intensity of pain on visual analogues scale | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Intensity of pain on visual analogue scale | 12 weeks | |
| Back function - FFbH-R-Questionnaire | 4 weeks, 12 weeks | |
| Quality of Life - SF 36 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benno Brinkhaus, Professor | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité Universitätsmedizin Berlin | Berlin | 10117 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29609566 | Derived | 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. |
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|
| Minimal Cupping | Device | 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). |
|
|
| 4 weeks, 12 weeks |
| Assessment of perceived effect on Likert Scale | 4 weeks, 12 weeks |
| Intake of paracetamol | 4 weeks |
| Adverse events | week 1- 12 |