Chronic Low Back PainCupping-LBPNCT02090686
Pulsatile Cupping in Low Back Pain
A study testing Pulsatile Cupping and Minimal Cupping in people with Chronic Low Back Pain, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Pulsatile Cupping and Minimal Cupping
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2014to 28 Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Chronic Low Back Pain
- Being tested
- Pulsatile Cupping, Minimal Cupping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsatile CuppingDevice
Also called HeVaTech PST 30 pulsatile cupping device
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)
Minimal CuppingDevice
Also called HeVaTech PST 30 pulsatile cupping device
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).
| Study group | Role | What they receive |
|---|---|---|
| Pulsatile Cupping | Active comparator | Not described Receives: Device: Pulsatile Cupping |
| Minimal Cupping | Active comparator | Not described Receives: Device: Minimal Cupping |
| No Intervention | No intervention | Waiting list |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of pain on visual analogues scale
Measured: 4 weeks
Secondary outcomes (6)
Intensity of pain on visual analogue scale
Measured: 12 weeks
Back function - FFbH-R-Questionnaire
Measured: 4 weeks, 12 weeks
Quality of Life - SF 36
Measured: 4 weeks, 12 weeks
Assessment of perceived effect on Likert Scale
Measured: 4 weeks, 12 weeks
Intake of paracetamol
Measured: 4 weeks
Adverse events
Measured: week 1- 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionOct 2014
- Study completion28 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- HeVaTech GmbH
- Responsible party
- Principal investigator, Benno Brinkhaus, Charite University, Berlin, Germany
- Investigators
- Benno Brinkhaus, Professor, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02090686
- Sponsor's protocol ID
- Cupping-LBP
- Acronym
- Cupping-LBP
- Status last verified
- Feb 2018
- First submitted
- 17 Mar 2014
- Last updated
- 20 Feb 2018
- Results posted
- No
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.
PubMed 29609566
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pulsatile Cupping in Patients With Chronic Low Back Pain - a Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT02090686
- Acronym / sponsor ID
- Cupping-LBP / Cupping-LBP
- Conditions
- Chronic Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- HeVaTech GmbH
- Study start
- Mar 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- 28 Feb 2015 (actual)
- First posted
- 18 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pulsatile Cupping | Active comparator | Device: Pulsatile Cupping |
| Minimal Cupping | Active comparator | Device: Minimal Cupping |
| No Intervention | No intervention | –Waiting list |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsatile CuppingAlso: HeVaTech PST 30 pulsatile cupping device8 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) | Device | Pulsatile Cupping |
| Minimal CuppingAlso: HeVaTech PST 30 pulsatile cupping device8 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). | Device | Minimal Cupping |
Primary outcome
Intensity of pain on visual analogues scale
Time frame: 4 weeks
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2018.
- Derived from this study: PubMed 29609566Teut 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benno Brinkhaus, Professor principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsatile Cupping and Minimal Cupping in people with Chronic Low Back Pain, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of pain on visual analogues scale (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02090686, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2018; AzTrials last refreshed its copy on 3 Nov 2026.