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Completed

NCT Number: NCT01635634

Cupping in Fibromyalgia

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

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinik für Naturheilkunde

Essen, 45276, Germany

About this study

see above

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cupping therapy

Other

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)

Primary outcomes

  1. Pain Intensity

    Time frame: Day 18

    Pain on a 100mm visual analog scale

Secondary outcomes

  1. Pain Intensity

    Time frame: Day 200

    Pain intensity measured on a 100mm visual analog scale

  2. Fatigue

    Time frame: Day 18

    Fatigue measured by the Multidimensional Fatigue Inventory (MFI) (Smets, Garssen, Bonke et al., 1995

  3. Fatigue

    Time frame: Day 200

    Fatigue measured by the Multidimensional Fatigue Inventory (MFI) (Smets, Garssen, Bonke et al., 1995

  4. Sleep Quality

    Time frame: Day 18

    measured by the Pittsburgh Sleep Quality Index (PSQI) (Buysse et al. 1989)

  5. Sleep Quality

    Time frame: Day 200

    measured by the Pittsburgh Sleep Quality Index (PSQI) (Buysse et al. 1989)

  6. Quality of life

    Time frame: Day 18

    measured by the SF-36 (Bullinger & Kirchberger, 1998)

  7. Quality of life

    Time frame: Day 200

    measured by the SF-36 (Bullinger & Kirchberger, 1998)

  8. Medication

    Time frame: Day 18

    measured by a medication log, daily entering of used drugs

  9. adverse events

    Time frame: Day 18

    all adverse events

  10. Pressure pain sensitivity

    Time frame: Day 18

    using an electronic algometer (Somedic, Sweden) to determine threshold of pain perception on predefined muscles

  11. Disability

    Time frame: Day 18

    measured by the FI (fibromyalgia impact questionnaire) (Offenbaecher, Waltz, Schoeps , 2000)

  12. Disability

    Time frame: Day 200

    measured by the FI (fibromyalgia impact questionnaire) (Offenbaecher, Waltz, Schoeps , 2000)

Sponsors and collaborators

Lead sponsor

Universität Duisburg-Essen

Other

Registry information

Official study title

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

Acronym: CuFib

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Jul 9, 2012
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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