Cupping in Fibromyalgia

Not Applicable

Completed

• Conditions: Fibromyalgia
• Interventions: Other: Cupping therapy

• Registration Number: NCT01635634
• Lead Sponsor: Universität Duisburg-Essen

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

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-07-03
• Study First Submitted QC: 2012-07-06
• Study First Posted: 2012-07-09
• Primary Completion: 2014-07
• Study Completion: 2015-03
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-04
• Last Update Posted: 2018-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 141

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cupping Therapy	Cupping therapy	Dry Cupping 5 serial treatments twice weekly 4-8 cups at the upper and lower back
Sham Cupping	Cupping therapy	Dry Cupping Therapy 5 serial treatments twice weekly 4-8 cups at the upper and lower back

Primary Outcome Measures

Name	Time	Method
Pain Intensity	Day 18	Pain on a 100mm visual analog scale

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Klinik für Naturheilkunde; 🇩🇪 Essen, Germany