NCT01635634CompletedNot Applicable
Randomized Controlled Pilot Trial: The Effectiveness of Cupping in Patients With Fibromyalgia
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universität Duisburg-Essen
- Enrollment
- 141
- Locations
- 2
- Primary Endpoint
- Pain Intensity
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Sham Cupping
Sham Comparator
Dry Cupping Therapy 5 serial treatments twice weekly 4-8 cups at the upper and lower back
Intervention: Cupping therapy (Other)
Cupping Therapy
Experimental
Dry Cupping 5 serial treatments twice weekly 4-8 cups at the upper and lower back
Intervention: Cupping therapy (Other)
Wait list
No Intervention
Wait list control no specific intervention for 3 weeks study period
Outcomes
Primary Outcomes
Pain Intensity
Time Frame: Day 18
Pain on a 100mm visual analog scale
Secondary Outcomes
- Fatigue(Day 200)
- Sleep Quality(Day 200)
- Quality of life(Day 200)
- Medication(Day 18)
- Pain Intensity(Day 200)
- adverse events(Day 18)
- Pressure pain sensitivity(Day 18)
- Disability(Day 200)
Investigators
Jost Langhorst
Prof. Dr. med.
Universität Duisburg-Essen
Study Sites (2)
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