Cupping in Fibromyalgia (CuFib)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jost Langhorst, Universität Duisburg-Essen
ClinicalTrials.gov Identifier:
NCT01635634
First received: July 3, 2012
Last updated: July 20, 2014
Last verified: July 2014
  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: January 2015
Primary Completion Date: July 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Klinik für Naturheilkunde
Essen, Germany, 45276
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: July 20, 2014
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 July 24, 2014