FibromyalgiaCuFibNCT01635634
Cupping in Fibromyalgia
A study testing Cupping therapy in people with Fibromyalgia, run by Universität Duisburg-Essen at 1 site in Germany.
Trial summary
The purpose of this randomized controlled study is to determine the effectiveness of cupping in patients with fibromyalgia compared to sham cupping. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Cupping therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 141 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2012to Mar 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- FMS diagnosis according to AWMF Guidelines,
- necessary documents: medical records
- Pain intensity > 45mm VAS
- Participation in cupping twice weekly on appointment
Who cannot join
- pregnancy
- other study participation
- pain due to other rheumatic disease
- major psychiatric disorder
- substance abuse
- severe somatic disorder (cancer)
- injections, acupuncture, neural therapy within the past 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Pilot Trial: The Effectiveness of Cupping in Patients With Fibromyalgia
The purpose of this randomized controlled study is to determine the effectiveness of cupping in patients with fibromyalgia compared to sham cupping.
Read the detailed description
see above
- Conditions
- Fibromyalgia
- Being tested
- Cupping therapy
- Keywords
- Fibromyalgia, Cupping
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cupping therapyOther
Cups are placed at the skin; local suction is created on the skin; it mobilizes blood flow; the suction is created by a mechanical device (Pneumatron, Pneumed, Germany)
| Study group | Role | What they receive |
|---|---|---|
| Sham Cupping | Sham comparator | Dry Cupping Therapy 5 serial treatments twice weekly 4-8 cups at the upper and lower back Receives: Other: Cupping therapy |
| Cupping Therapy | Experimental | Dry Cupping 5 serial treatments twice weekly 4-8 cups at the upper and lower back Receives: Other: Cupping therapy |
| Wait list | No intervention | Wait list control no specific intervention for 3 weeks study period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Pain on a 100mm visual analog scale
Measured: Day 18
Secondary outcomes (12)
Pain Intensity
Pain intensity measured on a 100mm visual analog scale
Measured: Day 200
Fatigue
Fatigue measured by the Multidimensional Fatigue Inventory (MFI) (Smets, Garssen, Bonke et al., 1995
Measured: Day 18
Fatigue
Fatigue measured by the Multidimensional Fatigue Inventory (MFI) (Smets, Garssen, Bonke et al., 1995
Measured: Day 200
Sleep Quality
measured by the Pittsburgh Sleep Quality Index (PSQI) (Buysse et al. 1989)
Measured: Day 18
Sleep Quality
measured by the Pittsburgh Sleep Quality Index (PSQI) (Buysse et al. 1989)
Measured: Day 200
Quality of life
measured by the SF-36 (Bullinger \& Kirchberger, 1998)
Measured: Day 18
Quality of life
measured by the SF-36 (Bullinger \& Kirchberger, 1998)
Measured: Day 200
Medication
measured by a medication log, daily entering of used drugs
Measured: Day 18
adverse events
all adverse events
Measured: Day 18
Pressure pain sensitivity
using an electronic algometer (Somedic, Sweden) to determine threshold of pain perception on predefined muscles
Measured: Day 18
Disability
measured by the FI (fibromyalgia impact questionnaire) (Offenbaecher, Waltz, Schoeps , 2000)
Measured: Day 18
Disability
measured by the FI (fibromyalgia impact questionnaire) (Offenbaecher, Waltz, Schoeps , 2000)
Measured: Day 200
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionJul 2014
- Study completionMar 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 FibromyalgiaStudies of the same condition, open and under way.
- 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
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jost Langhorst, Universität Duisburg-Essen
- Investigators
- Jost Langhorst, MD, Prof, Principal investigator, University of Duisburg-Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01635634
- Sponsor's protocol ID
- CuFib
- Acronym
- CuFib
- Status last verified
- May 2018
- First submitted
- 3 Jul 2012
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Lauche R, Spitzer J, Schwahn B, Ostermann T, Bernardy K, Cramer H, Dobos G, Langhorst J. Efficacy of cupping therapy in patients with the fibromyalgia syndrome-a randomised placebo controlled trial. Sci Rep. 2016 Nov 17;6:37316. doi: 10.1038/srep37316.
PubMed 27853272
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Pilot Trial: The Effectiveness of Cupping in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT01635634
- Acronym / sponsor ID
- CuFib / CuFib
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Cupping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 9 Jul 2012 (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 randomized controlled study is to determine the effectiveness of cupping in patients with fibromyalgia compared to sham cupping.
Detailed description
see above
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sham Cupping | Sham comparator | Other: Cupping therapyDry Cupping Therapy 5 serial treatments twice weekly 4-8 cups at the upper and lower back |
| Cupping Therapy | Experimental | Other: Cupping therapyDry Cupping 5 serial treatments twice weekly 4-8 cups at the upper and lower back |
| Wait list | No intervention | –Wait list control no specific intervention for 3 weeks study period |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- FMS diagnosis according to AWMF Guidelines,
- necessary documents: medical records
- Pain intensity > 45mm VAS
- Participation in cupping twice weekly on appointment
Key exclusion criteria (7 listed)
- pregnancy
- other study participation
- pain due to other rheumatic disease
- major psychiatric disorder
- substance abuse
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 |
|---|---|---|
| Cupping therapyCups are placed at the skin; local suction is created on the skin; it mobilizes blood flow; the suction is created by a mechanical device (Pneumatron, Pneumed, Germany) | Other | Cupping Therapy, Sham Cupping |
Primary outcome
Pain Intensity
Time frame: Day 18
Pain on a 100mm visual analog scale
12 secondary outcomes
Pain Intensity
Time frame: Day 200
Fatigue
Time frame: Day 18
Fatigue
Time frame: Day 200
Sleep Quality
Time frame: Day 18
Sleep Quality
Time frame: Day 200
Quality of life
Time frame: Day 18
Quality of life
Time frame: Day 200
Medication
Time frame: Day 18
adverse events
Time frame: Day 18
Pressure pain sensitivity
Time frame: Day 18
Disability
Time frame: Day 18
Disability
Time frame: Day 200
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 11 May 2018.
- Background: PubMed 27853272Lauche R, Spitzer J, Schwahn B, Ostermann T, Bernardy K, Cramer H, Dobos G, Langhorst J. Efficacy of cupping therapy in patients with the fibromyalgia syndrome-a randomised placebo controlled trial. Sci Rep. 2016 Nov 17;6:37316. doi: 10.1038/srep37316.
- Homepage of the ClinicLink provided by the sponsor.
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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.
Jost Langhorst, MD, Prof principal investigator
University of Duisburg-Essen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cupping therapy in people with Fibromyalgia, run by Universität Duisburg-Essen 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 4 inclusion and 7 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 11 May 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. Some participants in this study may receive a placebo. 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?
Pain Intensity (time frame: Day 18). 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 NCT01635634, 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 11 May 2018.