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Completed

NCT Number: NCT02090686

Pulsatile Cupping in Low Back Pain

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.

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Key information

Conditions

Chronic Low Back Pain

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité Universitätsmedizin Berlin

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulsatile Cupping

Device

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)

Other names: HeVaTech PST 30 pulsatile cupping device

Minimal Cupping

Device

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).

Other names: HeVaTech PST 30 pulsatile cupping device

Primary outcomes

  1. Intensity of pain on visual analogues scale

    Time frame: 4 weeks

Secondary outcomes

  1. Intensity of pain on visual analogue scale

    Time frame: 12 weeks

  2. Back function - FFbH-R-Questionnaire

    Time frame: 4 weeks, 12 weeks

  3. Quality of Life - SF 36

    Time frame: 4 weeks, 12 weeks

  4. Assessment of perceived effect on Likert Scale

    Time frame: 4 weeks, 12 weeks

  5. Intake of paracetamol

    Time frame: 4 weeks

  6. Adverse events

    Time frame: week 1- 12

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • HeVaTech GmbH

Registry information

Official study title

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

Acronym: Cupping-LBP

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Mar 18, 2014
Registry last updated
Feb 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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