Cupping in Fibromyalgia (CuFib)

This study is currently recruiting participants.
Verified October 2013 by Universität Duisburg-Essen
Sponsor:
Information provided by (Responsible Party):
Jost Langhorst, Universität Duisburg-Essen
ClinicalTrials.gov Identifier:
NCT01635634
First received: July 3, 2012
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention
Fibromyalgia
Other: Cupping therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Pilot Trial: The Effectiveness of Cupping in Patients With Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Universität Duisburg-Essen:

Primary Outcome Measures:
  • Pain Intensity [ Time Frame: Day 18 ] [ Designated as safety issue: No ]
    Pain on a 100mm visual analog scale


Secondary Outcome Measures:
  • Pain Intensity [ Time Frame: Day 200 ] [ Designated as safety issue: No ]
    Pain intensity measured on a 100mm visual analog scale

  • Fatigue [ Time Frame: Day 18 ] [ Designated as safety issue: No ]
    Fatigue measured by the Multidimensional Fatigue Inventory (MFI) (Smets, Garssen, Bonke et al., 1995

  • Fatigue [ Time Frame: Day 200 ] [ Designated as safety issue: No ]
    Fatigue measured by the Multidimensional Fatigue Inventory (MFI) (Smets, Garssen, Bonke et al., 1995

  • Sleep Quality [ Time Frame: Day 18 ] [ Designated as safety issue: No ]
    measured by the Pittsburgh Sleep Quality Index (PSQI) (Buysse et al. 1989)

  • Sleep Quality [ Time Frame: Day 200 ] [ Designated as safety issue: No ]
    measured by the Pittsburgh Sleep Quality Index (PSQI) (Buysse et al. 1989)

  • Quality of life [ Time Frame: Day 18 ] [ Designated as safety issue: No ]
    measured by the SF-36 (Bullinger & Kirchberger, 1998)

  • Quality of life [ Time Frame: Day 200 ] [ Designated as safety issue: No ]
    measured by the SF-36 (Bullinger & Kirchberger, 1998)

  • Medication [ Time Frame: Day 18 ] [ Designated as safety issue: No ]
    measured by a medication log, daily entering of used drugs

  • adverse events [ Time Frame: Day 18 ] [ Designated as safety issue: Yes ]
    all adverse events

  • Pressure pain sensitivity [ Time Frame: Day 18 ] [ Designated as safety issue: No ]
    using an electronic algometer (Somedic, Sweden) to determine threshold of pain perception on predefined muscles

  • Disability [ Time Frame: Day 18 ] [ Designated as safety issue: No ]
    measured by the FI (fibromyalgia impact questionnaire) (Offenbaecher, Waltz, Schoeps , 2000)

  • Disability [ Time Frame: Day 200 ] [ Designated as safety issue: No ]
    measured by the FI (fibromyalgia impact questionnaire) (Offenbaecher, Waltz, Schoeps , 2000)


Estimated Enrollment: 141
Study Start Date: June 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Other Name: Cupping therapy
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)
Other Name: Cupping therapy
No Intervention: Wait list
Wait list control no specific intervention for 3 weeks study period

Detailed Description:

see above

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01635634

Contacts
Contact: Romy Lauche, PhD +49201-174 ext 25015 r.lauche@kliniken-essen-mitte.de

Locations
Germany
Klinik für Naturheilkunde Recruiting
Essen, Germany, 45276
Contact: Romy Lauche    +49201-174 ext 25015      
Sponsors and Collaborators
Universität Duisburg-Essen
Investigators
Principal Investigator: Jost Langhorst, MD, Prof University of Duisburg-Essen
  More Information

Additional Information:
No publications provided

Responsible Party: Jost Langhorst, Prof. Dr. med., Universität Duisburg-Essen
ClinicalTrials.gov Identifier: NCT01635634     History of Changes
Other Study ID Numbers: CuFib
Study First Received: July 3, 2012
Last Updated: October 29, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Universität Duisburg-Essen:
Fibromyalgia
Cupping

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 17, 2014