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Cupping in Fibromyalgia (CuFib)

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Cupping therapy
Sponsored by
Universität Duisburg-Essen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Cupping

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Klinik für Naturheilkunde

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Experimental

No Intervention

Arm Label

Sham Cupping

Cupping Therapy

Wait list

Arm Description

Dry Cupping Therapy 5 serial treatments twice weekly 4-8 cups at the upper and lower back

Dry Cupping 5 serial treatments twice weekly 4-8 cups at the upper and lower back

Wait list control no specific intervention for 3 weeks study period

Outcomes

Primary Outcome Measures

Pain Intensity
Pain on a 100mm visual analog scale

Secondary Outcome Measures

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

Full Information

First Posted
July 3, 2012
Last Updated
May 4, 2018
Sponsor
Universität Duisburg-Essen
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1. Study Identification

Unique Protocol Identification Number
NCT01635634
Brief Title
Cupping in Fibromyalgia
Acronym
CuFib
Official Title
Randomized Controlled Pilot Trial: The Effectiveness of Cupping in Patients With Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universität Duisburg-Essen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this randomized controlled study is to determine the effectiveness of cupping in patients with fibromyalgia compared to sham cupping.
Detailed Description
see above

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, Cupping

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
141 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham Cupping
Arm Type
Sham Comparator
Arm Description
Dry Cupping Therapy 5 serial treatments twice weekly 4-8 cups at the upper and lower back
Arm Title
Cupping Therapy
Arm Type
Experimental
Arm Description
Dry Cupping 5 serial treatments twice weekly 4-8 cups at the upper and lower back
Arm Title
Wait list
Arm Type
No Intervention
Arm Description
Wait list control no specific intervention for 3 weeks study period
Intervention Type
Other
Intervention Name(s)
Cupping therapy
Intervention Description
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 Outcome Measure Information:
Title
Pain Intensity
Description
Pain on a 100mm visual analog scale
Time Frame
Day 18
Secondary Outcome Measure Information:
Title
Pain Intensity
Description
Pain intensity measured on a 100mm visual analog scale
Time Frame
Day 200
Title
Fatigue
Description
Fatigue measured by the Multidimensional Fatigue Inventory (MFI) (Smets, Garssen, Bonke et al., 1995
Time Frame
Day 18
Title
Fatigue
Description
Fatigue measured by the Multidimensional Fatigue Inventory (MFI) (Smets, Garssen, Bonke et al., 1995
Time Frame
Day 200
Title
Sleep Quality
Description
measured by the Pittsburgh Sleep Quality Index (PSQI) (Buysse et al. 1989)
Time Frame
Day 18
Title
Sleep Quality
Description
measured by the Pittsburgh Sleep Quality Index (PSQI) (Buysse et al. 1989)
Time Frame
Day 200
Title
Quality of life
Description
measured by the SF-36 (Bullinger & Kirchberger, 1998)
Time Frame
Day 18
Title
Quality of life
Description
measured by the SF-36 (Bullinger & Kirchberger, 1998)
Time Frame
Day 200
Title
Medication
Description
measured by a medication log, daily entering of used drugs
Time Frame
Day 18
Title
adverse events
Description
all adverse events
Time Frame
Day 18
Title
Pressure pain sensitivity
Description
using an electronic algometer (Somedic, Sweden) to determine threshold of pain perception on predefined muscles
Time Frame
Day 18
Title
Disability
Description
measured by the FI (fibromyalgia impact questionnaire) (Offenbaecher, Waltz, Schoeps , 2000)
Time Frame
Day 18
Title
Disability
Description
measured by the FI (fibromyalgia impact questionnaire) (Offenbaecher, Waltz, Schoeps , 2000)
Time Frame
Day 200

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jost Langhorst, MD, Prof
Organizational Affiliation
University of Duisburg-Essen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik für Naturheilkunde
City
Essen
ZIP/Postal Code
45276
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
27853272
Citation
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.
Results Reference
background
Links:
URL
http://www.kliniken-essen-mitte.de/leistung/fachabteilungen/naturheilkunde-u-integrative-medizin/home.html
Description
Homepage of the Clinic

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Cupping in Fibromyalgia

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