Chronic Low Back Pain
Conditions
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.
Interventions
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)
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).
Sponsors
Study design
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intensity of pain on visual analogues scale | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Back function - FFbH-R-Questionnaire | 4 weeks, 12 weeks |
| Quality of Life - SF 36 | 4 weeks, 12 weeks |
| Intensity of pain on visual analogue scale | 12 weeks |
| Intake of paracetamol | 4 weeks |
| Adverse events | week 1- 12 |
| Assessment of perceived effect on Likert Scale | 4 weeks, 12 weeks |
Countries
Germany