NCT02090686CompletedNot Applicable
Efficacy of Pulsatile Cupping in Patients With Chronic Low Back Pain - a Randomized Controlled Study.
Charite University, Berlin, Germany1 site in 1 country110 target enrollmentStarted: March 1, 2014Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Intensity of pain on visual analogues scale
Study Overview
Brief Summary
The purpose of this study is to determine whether pulsatile cupping with a cupping device is effective in the treatment of patients with chronic low back pain compared to no cupping or to minimal cupping.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male and female, 18-65 years
- •Chronic low back pain (disease duration > 3 months)
- •Pain intensity on visual analogue scale at inclusion > 40 mm (0-100 mm scale)
- •Only pharmacological treatment with NSAID or no treatment in the last 4 weeks
- •Undersigned informed consent form
Exclusion Criteria
- •Use of anticoagulants (Phenprocoumon, Heparin)
- •Coagulopathy
- •Cupping in the last 6 weeks
- •Other CAM therapies in the last 12 weeks (e.g. acupuncture)
- •Physical therapy in the last 12 weeks (e.g. massage, osteopathy)
- •participation in another study in the last 3 months
- •Paracetamol allergy or intolerance
- •Pathological neurological symptoms such as muscular paralysis or paraesthesia due to spinal disc herniation or other causes
- •Known renal and / or hepatic diseases
- •Intake of central nervous system-acting analgesics in the last 6 weeks
- •Applying for early retirement due to low back pain
- •Severe disease that does not allow participation
- •No undersigned informed consent form
Arms & Interventions
Pulsatile Cupping
Active Comparator
Intervention: Pulsatile Cupping (Device)
No Intervention
No Intervention
Waiting list
Minimal Cupping
Active Comparator
Intervention: Minimal Cupping (Device)
Outcomes
Primary Outcomes
Intensity of pain on visual analogues scale
Time Frame: 4 weeks
Secondary Outcomes
- Intensity of pain on visual analogue scale(12 weeks)
- Back function - FFbH-R-Questionnaire(4 weeks, 12 weeks)
- Quality of Life - SF 36(4 weeks, 12 weeks)
- Assessment of perceived effect on Likert Scale(4 weeks, 12 weeks)
- Intake of paracetamol(4 weeks)
- Adverse events(week 1- 12)
Investigators
Benno Brinkhaus
Prof.
Charite University, Berlin, Germany
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Cupping in Osteoarthritis of the KneeOsteoarthritis of the KneeNCT01057043Charite University, Berlin, Germany40
Not yet recruiting
Phase 1
Study for the clinical efficacy of cupping therapy in the dog days in the treatment of repeated respiratory tract infection in childreRepeated respiratory tract infection in childrenITMCTR2000003206Chongqing Shapingba District People's Hospital
Recruiting
Phase 3
Effect of cupping on respiratory symptoms of COVID-19COVID-19.COVID-19, virus identifiedU07.1IRCT20200428047229N3Shahid Beheshti University of Medical Sciences72
Completed
Not Applicable
Cupping in FibromyalgiaFibromyalgiaNCT01635634Universität Duisburg-Essen141
Completed
Not Applicable
The Effects of Cupping Massage in Patients With Chronic Neck Pain - A Randomized Controlled TrialNeck PainMechanical/Motor Problems With Neck and TrunkNCT02651766Universität Duisburg-Essen50