Cupping in Fibromyalgia (CuFib)

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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Other: Cupping therapy

Detailed Description

see above

• Study Type: Interventional
• Enrollment (Actual): 141
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Essen, Germany, 45276
    • Klinik für Naturheilkunde

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham Cupping; Dry Cupping Therapy 5 serial treatments twice weekly 4-8 cups at the upper and lower back	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)
Experimental: Cupping Therapy; Dry Cupping 5 serial treatments twice weekly 4-8 cups at the upper and lower back	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)
No Intervention: Wait list; Wait list control no specific intervention for 3 weeks study period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity	Pain on a 100mm visual analog scale	Day 18

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universität Duisburg-Essen
• Investigators: Principal Investigator: Jost Langhorst, MD, Prof, University of Duisburg-Essen

Publications and helpful links

General 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.

Helpful Links

• Homepage of the Clinic

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: July 3, 2012
• First Submitted That Met QC Criteria: July 6, 2012
• First Posted (Estimate): July 9, 2012

Study Record Updates

• Last Update Posted (Actual): May 11, 2018
• Last Update Submitted That Met QC Criteria: May 4, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Fibromyalgia; Cupping
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: CuFib