Pulsatile Cupping in Low Back Pain (Cupping-LBP)

February 19, 2018 updated by: Benno Brinkhaus, Charite University, Berlin, Germany

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charite Universitatsmedizin Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pulsatile Cupping
Device: 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)

Other Names:
  • HeVaTech PST 30 pulsatile cupping device
Active Comparator: Minimal Cupping
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).
Other Names:
  • HeVaTech PST 30 pulsatile cupping device
No Intervention: No Intervention
Waiting list

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intensity of pain on visual analogues scale
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Intensity of pain on visual analogue scale
Time Frame: 12 weeks
12 weeks
Back function - FFbH-R-Questionnaire
Time Frame: 4 weeks, 12 weeks
4 weeks, 12 weeks
Quality of Life - SF 36
Time Frame: 4 weeks, 12 weeks
4 weeks, 12 weeks
Assessment of perceived effect on Likert Scale
Time Frame: 4 weeks, 12 weeks
4 weeks, 12 weeks
Intake of paracetamol
Time Frame: 4 weeks
4 weeks
Adverse events
Time Frame: week 1- 12
week 1- 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

HeVaTech GmbH

Investigators

  • Principal Investigator: Benno Brinkhaus, Professor, Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

February 28, 2015

Study Registration Dates

First Submitted

March 17, 2014

First Submitted That Met QC Criteria

March 17, 2014

First Posted (Estimate)

March 18, 2014

Study Record Updates

Last Update Posted (Actual)

February 20, 2018

Last Update Submitted That Met QC Criteria

February 19, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cupping-LBP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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