Pulsatile Cupping in Low Back Pain

NCT ID: NCT02090686

Last Updated: 2018-02-20

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Pulsatile Cupping

Group Type ACTIVE_COMPARATOR

Pulsatile Cupping

Intervention Type 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)

Minimal Cupping

Group Type ACTIVE_COMPARATOR

Minimal Cupping

Intervention Type 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).

No Intervention

Waiting list

Group Type NO_INTERVENTION

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)

Intervention Type DEVICE

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).

Intervention Type DEVICE

Other Intervention Names

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HeVaTech PST 30 pulsatile cupping device HeVaTech PST 30 pulsatile cupping device

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HeVaTech GmbH

UNKNOWN

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Benno Brinkhaus

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Germany

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.

Reference Type DERIVED
PMID: 29609566 (View on PubMed)

Other Identifiers

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Cupping-LBP

Identifier Type: -

Identifier Source: org_study_id

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