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Pulsatile Cupping in Low Back Pain

Efficacy of Pulsatile Cupping in Patients With Chronic Low Back Pain - a Randomized Controlled Study.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02090686
Acronym
Cupping-LBP
Enrollment
110
Registered
2014-03-18
Start date
2014-03-31
Completion date
2015-02-28
Last updated
2018-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Low Back Pain

Brief summary

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.

Interventions

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)

DEVICEMinimal 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).

Sponsors

HeVaTech GmbH
CollaboratorUNKNOWN
Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Male and female, 18-65 years * 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

* Use of anticoagulants (Phenprocoumon, Heparin) * 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

Design outcomes

Primary

MeasureTime frame
Intensity of pain on visual analogues scale4 weeks

Secondary

MeasureTime frame
Back function - FFbH-R-Questionnaire4 weeks, 12 weeks
Quality of Life - SF 364 weeks, 12 weeks
Intensity of pain on visual analogue scale12 weeks
Intake of paracetamol4 weeks
Adverse eventsweek 1- 12
Assessment of perceived effect on Likert Scale4 weeks, 12 weeks

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026