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Pulsatile Cupping in Low Back Pain (Cupping-LBP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02090686
Recruitment Status : Completed
First Posted : March 18, 2014
Last Update Posted : February 20, 2018
Sponsor:
Collaborator:
HeVaTech GmbH
Information provided by (Responsible Party):
Benno Brinkhaus, Charite University, Berlin, Germany

Tracking Information
First Submitted Date  ICMJE March 17, 2014
First Posted Date  ICMJE March 18, 2014
Last Update Posted Date February 20, 2018
Study Start Date  ICMJE March 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2014)
Intensity of pain on visual analogues scale [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2014)
  • Intensity of pain on visual analogue scale [ Time Frame: 12 weeks ]
  • Back function - FFbH-R-Questionnaire [ Time Frame: 4 weeks, 12 weeks ]
  • Quality of Life - SF 36 [ Time Frame: 4 weeks, 12 weeks ]
  • Assessment of perceived effect on Likert Scale [ Time Frame: 4 weeks, 12 weeks ]
  • Intake of paracetamol [ Time Frame: 4 weeks ]
  • Adverse events [ Time Frame: week 1- 12 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pulsatile Cupping in Low Back Pain
Official Title  ICMJE Efficacy of Pulsatile Cupping in Patients With Chronic Low Back Pain - a Randomized Controlled Study.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Chronic Low Back Pain
Intervention  ICMJE
  • 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 Name: HeVaTech PST 30 pulsatile cupping device
  • 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 Name: HeVaTech PST 30 pulsatile cupping device
Study Arms  ICMJE
  • Active Comparator: Pulsatile Cupping
    Intervention: Device: Pulsatile Cupping
  • Active Comparator: Minimal Cupping
    Intervention: Device: Minimal Cupping
  • No Intervention: No Intervention
    Waiting list
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 19, 2018)
110
Original Estimated Enrollment  ICMJE
 (submitted: March 17, 2014)
108
Actual Study Completion Date  ICMJE February 28, 2015
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02090686
Other Study ID Numbers  ICMJE Cupping-LBP
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Benno Brinkhaus, Charite University, Berlin, Germany
Study Sponsor  ICMJE Charite University, Berlin, Germany
Collaborators  ICMJE HeVaTech GmbH
Investigators  ICMJE
Principal Investigator: Benno Brinkhaus, Professor Charite University, Berlin, Germany
PRS Account Charite University, Berlin, Germany
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP