Cupping in Fibromyalgia

Fibromyalgia Clinical Trial

— CuFib  

Official title:

Randomized Controlled Pilot Trial: The Effectiveness of Cupping in Patients With Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01635634
• Other study ID #: CuFib
• Status: Completed
• Phase: N/A
• Start date: June 2012
• Est. completion date: March 2015

Study information

• Verified date: May 2018
• Source: Universität Duisburg-Essen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this randomized controlled study is to determine the effectiveness of cupping in patients with fibromyalgia compared to sham cupping.

Description:

see above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: March 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• FMS diagnosis according to AWMF Guidelines,

• necessary documents: medical records

• Pain intensity > 45mm VAS

• Participation in cupping twice weekly on appointment

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• Cupping therapy
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)

Locations

Country	Name	City	State
Germany	Klinik für Naturheilkunde	Essen

Sponsors (1)

Lead Sponsor	Collaborator
Universität Duisburg-Essen

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Intensity	Pain on a 100mm visual analog scale	Day 18
Secondary	Pain Intensity	Pain intensity measured on a 100mm visual analog scale	Day 200
Secondary	Fatigue	Fatigue measured by the Multidimensional Fatigue Inventory (MFI) (Smets, Garssen, Bonke et al., 1995	Day 18
Secondary	Fatigue	Fatigue measured by the Multidimensional Fatigue Inventory (MFI) (Smets, Garssen, Bonke et al., 1995	Day 200
Secondary	Sleep Quality	measured by the Pittsburgh Sleep Quality Index (PSQI) (Buysse et al. 1989)	Day 18
Secondary	Sleep Quality	measured by the Pittsburgh Sleep Quality Index (PSQI) (Buysse et al. 1989)	Day 200
Secondary	Quality of life	measured by the SF-36 (Bullinger & Kirchberger, 1998)	Day 18
Secondary	Quality of life	measured by the SF-36 (Bullinger & Kirchberger, 1998)	Day 200
Secondary	Medication	measured by a medication log, daily entering of used drugs	Day 18
Secondary	adverse events	all adverse events	Day 18
Secondary	Pressure pain sensitivity	using an electronic algometer (Somedic, Sweden) to determine threshold of pain perception on predefined muscles	Day 18
Secondary	Disability	measured by the FI (fibromyalgia impact questionnaire) (Offenbaecher, Waltz, Schoeps , 2000)	Day 18
Secondary	Disability	measured by the FI (fibromyalgia impact questionnaire) (Offenbaecher, Waltz, Schoeps , 2000)	Day 200

External Links

•   Homepage of the Clinic