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Cupping in Fibromyalgia (CuFib)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jost Langhorst, Universität Duisburg-Essen
ClinicalTrials.gov Identifier:
NCT01635634
First received: July 3, 2012
Last updated: April 21, 2015
Last verified: April 2015
July 3, 2012
April 21, 2015
June 2012
July 2014   (Final data collection date for primary outcome measure)
Pain Intensity [ Time Frame: Day 18 ]
Pain on a 100mm visual analog scale
Same as current
Complete list of historical versions of study NCT01635634 on ClinicalTrials.gov Archive Site
  • Pain Intensity [ Time Frame: Day 200 ]
    Pain intensity measured on a 100mm visual analog scale
  • Fatigue [ Time Frame: Day 18 ]
    Fatigue measured by the Multidimensional Fatigue Inventory (MFI) (Smets, Garssen, Bonke et al., 1995
  • Fatigue [ Time Frame: Day 200 ]
    Fatigue measured by the Multidimensional Fatigue Inventory (MFI) (Smets, Garssen, Bonke et al., 1995
  • Sleep Quality [ Time Frame: Day 18 ]
    measured by the Pittsburgh Sleep Quality Index (PSQI) (Buysse et al. 1989)
  • Sleep Quality [ Time Frame: Day 200 ]
    measured by the Pittsburgh Sleep Quality Index (PSQI) (Buysse et al. 1989)
  • Quality of life [ Time Frame: Day 18 ]
    measured by the SF-36 (Bullinger & Kirchberger, 1998)
  • Quality of life [ Time Frame: Day 200 ]
    measured by the SF-36 (Bullinger & Kirchberger, 1998)
  • Medication [ Time Frame: Day 18 ]
    measured by a medication log, daily entering of used drugs
  • adverse events [ Time Frame: Day 18 ]
    all adverse events
  • Pressure pain sensitivity [ Time Frame: Day 18 ]
    using an electronic algometer (Somedic, Sweden) to determine threshold of pain perception on predefined muscles
  • Disability [ Time Frame: Day 18 ]
    measured by the FI (fibromyalgia impact questionnaire) (Offenbaecher, Waltz, Schoeps , 2000)
  • Disability [ Time Frame: Day 200 ]
    measured by the FI (fibromyalgia impact questionnaire) (Offenbaecher, Waltz, Schoeps , 2000)
Same as current
Not Provided
Not Provided
 
Cupping in Fibromyalgia
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.
see above
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Fibromyalgia
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)
  • Sham Comparator: Sham Cupping
    Dry Cupping Therapy 5 serial treatments twice weekly 4-8 cups at the upper and lower back
    Intervention: Other: Cupping therapy
  • Experimental: Cupping Therapy
    Dry Cupping 5 serial treatments twice weekly 4-8 cups at the upper and lower back
    Intervention: Other: Cupping therapy
  • No Intervention: Wait list
    Wait list control no specific intervention for 3 weeks study period
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
141
March 2015
July 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01635634
CuFib
No
Not Provided
Not Provided
Jost Langhorst, Universität Duisburg-Essen
Universität Duisburg-Essen
Not Provided
Principal Investigator: Jost Langhorst, MD, Prof University of Duisburg-Essen
Universität Duisburg-Essen
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP