The Effectiveness of Wet Cupping on Persistent Non-specific Low Back Pain

Study Overview
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Brief Summary
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The hypothesis of this study is that the improvement of Numeric Rating Scale (NRS) for Pain at the end of the study will be greater in the Wet Cupping Treatment group than in the Waiting Control group.

Official Title
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The Effectiveness of Wet Cupping on Persistent Non-specific Low Back Pain: A Randomized, Waiting-list Controlled, Open-label, Parallel-group Pilot Study

Conditions
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Low Back Pain

Intervention / Treatment
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* Device: Wet Cupping
* Drug: Acetaminophen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have had non-specific low back pains at least 12 weeks now. Exclusion Criteria: Patients who have low back pain due to specific and known etiological causes (infection, tumor, osteoporosis, ankylosing spondylitis, fracture, inflammatory process, radicular syndrome, cauda equinal syndrome). Patients who are inappropriate to the wet cupping treatment. AIDS, Active Hepatitis, Tuberculosis, Syphilis Patients who regularly take anticoagulants, antiplatelet drugs Anemia, thrombocytopenia Hemorrhagic disease like hemophilia Diabetes Severe cardiovascular disease Kidney diseases (renal failure, chronic renal disease) Patients who have experiences of wet cupping treatment during last 3 months. Patients who have had treatment for low back pain during last 2 weeks. Patients who are in pregnancy or have plan to conception. Patients who have vertebra surgery or have plan of surgery. Patients who are inappropriate to join this trial judged by the radiologists or specialists.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 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
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wet Cupping<br> | Device: Wet Cupping<br>* Wet cupping (Seongho trade & company, Korea) will be practiced at two selected points (among the 6 acupoints, left or right BL23, BL24, BL25)<br>* Other names: Disposable wet cupping cup, Seongho trade & company, Korea;Drug: Acetaminophen<br>* Acetaminophen 500 mg tablets will be offered to both of the wet cupping group and waiting group for relieving severe pain.<br>|
| No Intervention: Waiting Control<br>They can't use any other specific treatment except exercises and behavior modification (we'll offer a brochure which includes exercise method and directions about behavior modifications). | Drug: Acetaminophen<br>* Acetaminophen 500 mg tablets will be offered to both of the wet cupping group and waiting group for relieving severe pain.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Rating Scale (NRS) for pain |  | study group: at base line, post-treatment, 4 weeks later after allocation; control group: at base line, 4 weeks later after allocation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Present Pain Intensity Scale of the McGill Pain Questionaire (PPI) |  | study group: at base line, post-treatment, 4 weeks later after allocation; control group: at base line, 4 weeks later after allocation | 
| Oswestry Disability Questionnaire (ODQ) |  | study group: at base line, post-treatment, 4 weeks later after allocation; control group: at base line, 4 weeks later after allocation | 
| Medication Quantification Scale (MQS) |  | study group: at base line, post-treatment, 4 weeks later after allocation; control group: at base line, 4 weeks later after allocation | 
| General Assessment of Doctors and Subjects |  | study group: at base line, post-treatment, 4 weeks later after allocation; control group: at base line, 4 weeks later after allocation | 
| Safety measurement |  | study group: at base line, post-treatment, 4 weeks later after allocation; control group: at base line, 4 weeks later after allocation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Persistent Non-specific Low Back Pain, wet cupping, cupping, Numerical Rating Scale