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Pulsatile Cupping in Low Back Pain (Cupping-LBP)

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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

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.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Device: Pulsatile Cupping Device: Minimal Cupping Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy of Pulsatile Cupping in Patients With Chronic Low Back Pain - a Randomized Controlled Study.
Study Start Date : March 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : February 28, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

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 Name: 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 Name: HeVaTech PST 30 pulsatile cupping device

No Intervention: No Intervention
Waiting list



Primary Outcome Measures :
  1. Intensity of pain on visual analogues scale [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Intensity of pain on visual analogue scale [ Time Frame: 12 weeks ]
  2. Back function - FFbH-R-Questionnaire [ Time Frame: 4 weeks, 12 weeks ]
  3. Quality of Life - SF 36 [ Time Frame: 4 weeks, 12 weeks ]
  4. Assessment of perceived effect on Likert Scale [ Time Frame: 4 weeks, 12 weeks ]
  5. Intake of paracetamol [ Time Frame: 4 weeks ]
  6. Adverse events [ Time Frame: week 1- 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02090686


Locations
Germany
Charité Universitätsmedizin Berlin
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
HeVaTech GmbH
Investigators
Principal Investigator: Benno Brinkhaus, Professor Charite University, Berlin, Germany

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Benno Brinkhaus, Prof., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02090686     History of Changes
Other Study ID Numbers: Cupping-LBP
First Posted: March 18, 2014    Key Record Dates
Last Update Posted: February 20, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms