Cupping in Fibromyalgia

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

Detailed Description
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see above

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

Conditions
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Fibromyalgia

Intervention / Treatment
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* Other: Cupping therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham Cupping<br>Dry Cupping Therapy 5 serial treatments twice weekly 4-8 cups at the upper and lower back | Other: Cupping therapy<br>* 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)<br>|
| Experimental: Cupping Therapy<br>Dry Cupping 5 serial treatments twice weekly 4-8 cups at the upper and lower back | Other: Cupping therapy<br>* 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)<br>|
| No Intervention: Wait list<br>Wait list control no specific intervention for 3 weeks study period | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity | Pain on a 100mm visual analog scale | Day 18 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity | Pain intensity measured on a 100mm visual analog scale | Day 200 | 
| Fatigue | Fatigue measured by the Multidimensional Fatigue Inventory (MFI) (Smets, Garssen, Bonke et al., 1995 | Day 18 | 
| Fatigue | Fatigue measured by the Multidimensional Fatigue Inventory (MFI) (Smets, Garssen, Bonke et al., 1995 | Day 200 | 
| Sleep Quality | measured by the Pittsburgh Sleep Quality Index (PSQI) (Buysse et al. 1989) | Day 18 | 
| Sleep Quality | measured by the Pittsburgh Sleep Quality Index (PSQI) (Buysse et al. 1989) | Day 200 | 
| Quality of life | measured by the SF-36 (Bullinger & Kirchberger, 1998) | Day 18 | 
| Quality of life | measured by the SF-36 (Bullinger & Kirchberger, 1998) | Day 200 | 
| Medication | measured by a medication log, daily entering of used drugs | Day 18 | 
| adverse events | all adverse events | Day 18 | 
| Pressure pain sensitivity | using an electronic algometer (Somedic, Sweden) to determine threshold of pain perception on predefined muscles | Day 18 | 
| Disability | measured by the FI (fibromyalgia impact questionnaire) (Offenbaecher, Waltz, Schoeps , 2000) | Day 18 | 
| Disability | measured by the FI (fibromyalgia impact questionnaire) (Offenbaecher, Waltz, Schoeps , 2000) | Day 200 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibromyalgia, Cupping