Pulsatile Cupping in Low Back Pain

Overview

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.

Full Title of Study: “Efficacy of Pulsatile Cupping in Patients With Chronic Low Back Pain – a Randomized Controlled Study.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: October 2014

Interventions

  • 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)
  • Device: 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).

Arms, Groups and Cohorts

  • Active Comparator: Pulsatile Cupping
  • Active Comparator: Minimal Cupping
  • No Intervention: No Intervention
    • Waiting list

Clinical Trial Outcome Measures

Primary Measures

  • Intensity of pain on visual analogues scale
    • Time Frame: 4 weeks

Secondary Measures

  • Intensity of pain on visual analogue scale
    • Time Frame: 12 weeks
  • Back function – FFbH-R-Questionnaire
    • Time Frame: 4 weeks, 12 weeks
  • Quality of Life – SF 36
    • Time Frame: 4 weeks, 12 weeks
  • Assessment of perceived effect on Likert Scale
    • Time Frame: 4 weeks, 12 weeks
  • Intake of paracetamol
    • Time Frame: 4 weeks
  • Adverse events
    • Time Frame: week 1- 12

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Charite University, Berlin, Germany
  • Collaborator
    • HeVaTech GmbH
  • Provider of Information About this Clinical Study
    • Principal Investigator: Benno Brinkhaus, Prof. – Charite University, Berlin, Germany
  • Overall Official(s)
    • Benno Brinkhaus, Professor, Principal Investigator, Charite University, Berlin, Germany

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