Pulsatile Cupping in Low Back Pain

Chronic Low Back Pain Clinical Trial

— Cupping-LBP  

Official title:

Efficacy of Pulsatile Cupping in Patients With Chronic Low Back Pain - a Randomized Controlled Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02090686
• Other study ID #: Cupping-LBP
• Status: Completed
• Phase: N/A
• First received: March 17, 2014
• Last updated: February 19, 2018
• Start date: March 2014
• Est. completion date: February 28, 2015

Study information

• Verified date: February 2018
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: February 28, 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Device:
• Pulsatile Cupping
8 cupping sessions (each 8 minutes) in 4 weeks (-150 to -350 mbar), interval 2 seconds. Paracetamol on demand as rescue medication (maximum dosage 4 x500 mg/day)
• Minimal Cupping
8 cupping sessions (each 8 minutes) in 4 weeks witth (-60 to -70 mbar). Paracetamol on demand as rescue medication (maximum dosage 4 x500 mg/day).

Locations

Country	Name	City	State
Germany	Charité Universitätsmedizin Berlin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	HeVaTech GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensity of pain on visual analogues scale		4 weeks
Secondary	Intensity of pain on visual analogue scale		12 weeks
Secondary	Back function - FFbH-R-Questionnaire		4 weeks, 12 weeks
Secondary	Quality of Life - SF 36		4 weeks, 12 weeks
Secondary	Assessment of perceived effect on Likert Scale		4 weeks, 12 weeks
Secondary	Intake of paracetamol		4 weeks
Secondary	Adverse events		week 1- 12