NCT02090686

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 18, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2015

Completed
Last Updated

February 20, 2018

Status Verified

February 1, 2018

Enrollment Period

7 months

First QC Date

March 17, 2014

Last Update Submit

February 19, 2018

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • Intensity of pain on visual analogues scale

    4 weeks

Secondary Outcomes (6)

  • Intensity of pain on visual analogue scale

    12 weeks

  • Back function - FFbH-R-Questionnaire

    4 weeks, 12 weeks

  • Quality of Life - SF 36

    4 weeks, 12 weeks

  • Assessment of perceived effect on Likert Scale

    4 weeks, 12 weeks

  • Intake of paracetamol

    4 weeks

  • +1 more secondary outcomes

Study Arms (3)

Pulsatile Cupping

ACTIVE COMPARATOR
Device: Pulsatile Cupping

Minimal Cupping

ACTIVE COMPARATOR
Device: Minimal Cupping

No Intervention

NO INTERVENTION

Waiting list

Interventions

Pulsatile CuppingDEVICE

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)

Also known as: HeVaTech PST 30 pulsatile cupping device
Pulsatile Cupping
Minimal CuppingDEVICE

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).

Also known as: HeVaTech PST 30 pulsatile cupping device
Minimal Cupping

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female, 18-65 years
  • Chronic low back pain (disease duration \> 3 months)
  • Only pharmacological treatment with NSAID or no treatment in the last 4 weeks
  • Undersigned informed consent form

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Related Publications (1)

  • 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.

    PMID: 29609566DERIVED

Study Officials

  • Benno Brinkhaus, Professor

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

March 17, 2014

First Posted

March 18, 2014

Study Start

March 1, 2014

Primary Completion

October 1, 2014

Study Completion

February 28, 2015

Last Updated

February 20, 2018

Record last verified: 2018-02

Locations

DE(1)