Pulsatile Cupping in Low Back Pain

Not Applicable

Completed

• Conditions: Chronic Low Back Pain
• Interventions: Device: Minimal Cupping; Device: Pulsatile Cupping

• Registration Number: NCT02090686
• Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-17
• Study First Submitted QC: 2014-03-17
• Study First Posted: 2014-03-18
• Primary Completion: 2014-10
• Study Completion: 2015-02-28
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-19
• Last Update Posted: 2018-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Minimal Cupping	Minimal Cupping	-
Pulsatile Cupping	Pulsatile Cupping	-

Primary Outcome Measures

Name	Time	Method
Intensity of pain on visual analogues scale	4 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Charité Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany