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Pulsatile Cupping in Low Back Pain (Cupping-LBP)

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Pulsatile Cupping
Minimal Cupping
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charité Universitätsmedizin Berlin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Pulsatile Cupping

Minimal Cupping

No Intervention

Arm Description

Waiting list

Outcomes

Primary Outcome Measures

Intensity of pain on visual analogues scale

Secondary Outcome Measures

Intensity of pain on visual analogue scale
Back function - FFbH-R-Questionnaire
Quality of Life - SF 36
Assessment of perceived effect on Likert Scale
Intake of paracetamol
Adverse events

Full Information

First Posted
March 17, 2014
Last Updated
February 19, 2018
Sponsor
Charite University, Berlin, Germany
Collaborators
HeVaTech GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT02090686
Brief Title
Pulsatile Cupping in Low Back Pain
Acronym
Cupping-LBP
Official Title
Efficacy of Pulsatile Cupping in Patients With Chronic Low Back Pain - a Randomized Controlled Study.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
February 28, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
HeVaTech GmbH

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
Participant
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pulsatile Cupping
Arm Type
Active Comparator
Arm Title
Minimal Cupping
Arm Type
Active Comparator
Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
Waiting list
Intervention Type
Device
Intervention Name(s)
Pulsatile Cupping
Other Intervention Name(s)
HeVaTech PST 30 pulsatile cupping device
Intervention Description
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
Intervention Name(s)
Minimal Cupping
Other Intervention Name(s)
HeVaTech PST 30 pulsatile cupping device
Intervention Description
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).
Primary Outcome Measure Information:
Title
Intensity of pain on visual analogues scale
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Intensity of pain on visual analogue scale
Time Frame
12 weeks
Title
Back function - FFbH-R-Questionnaire
Time Frame
4 weeks, 12 weeks
Title
Quality of Life - SF 36
Time Frame
4 weeks, 12 weeks
Title
Assessment of perceived effect on Likert Scale
Time Frame
4 weeks, 12 weeks
Title
Intake of paracetamol
Time Frame
4 weeks
Title
Adverse events
Time Frame
week 1- 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benno Brinkhaus, Professor
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
29609566
Citation
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.
Results Reference
derived

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Pulsatile Cupping in Low Back Pain

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