Pulsatile Cupping in Low Back Pain

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Device: Pulsatile Cupping
* Device: Minimal Cupping


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pulsatile Cupping<br> | Device: Pulsatile Cupping<br>* 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)<br>* Other names: HeVaTech PST 30 pulsatile cupping device;|
| Active Comparator: Minimal Cupping<br> | Device: Minimal Cupping<br>* 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).<br>* Other names: HeVaTech PST 30 pulsatile cupping device;|
| No Intervention: No Intervention<br>Waiting list | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of pain on visual analogues scale |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |