Hemodynamic Changes During Dry Cupping Therapy on Low Back Pain

Study Overview
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Brief Summary
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This study aims to investigate the hemodynamic changes during dry cupping therapy (DCT) on low back pain. 50 patients with low back pain as experimental group and 50 healthy people as control group are treated by DCT. They will receive four consecutive WCT application in one month. Optical sensors were used to monitor the hemodynamic changes including oxyhemoglobin ([HbO2]), deoxy-hemoglobin ([Hb]) and the derived change in blood volume ([tHb]) in/surround the cupping sites during treatment. The investigators hope to interpret the curative effect of DCT from the perspective of modern hemodynamics.

Official Title
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Hemodynamic Changes During Dry Cupping Therapy on Low Back Pain

Conditions
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Oxygen Metabolism, Muscle Spasticity

Intervention / Treatment
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* Procedure: Negative pressure therapy


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. Healthy people who are interested in dry cupping therapy Exclusion Criteria: Patients who have had non-specific low back pains at least 12 weeks now. Healthy people who are interested in dry cupping therapy 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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dry cupping for patients of low back pain<br>Patients will receive four consecutive dry cupping therapy application in one month. | Procedure: Negative pressure therapy<br>* Participants assigned to the treatment group will receive wet-cupping therapy 1 times per week for 4 weeks<br>* Other names: Dry cupping therapy;|
| Active Comparator: dry cupping for health people<br>Health people will receive four consecutive dry cupping therapy application in one month. | Procedure: Negative pressure therapy<br>* Participants assigned to the treatment group will receive wet-cupping therapy 1 times per week for 4 weeks<br>* Other names: Dry cupping therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Δ[HbO2] | the concentration changes of oxyhemoglobin (higher alternation means better curative effect) | all groups: up to 4 weeks | 
| Δ[Hb] | the concentration changes of deoxyhemoglobin (higher alternation means better curative effect) | all groups: up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Δ[tHb] | the concentration changes of blood volume (higher alternation means better curative effect) | all groups: up to 4 weeks | 
| NRS | Numeric Rating Scale for pain (lower score means better curative effect) | experimental group: up to 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cupping Therapy, Near Infrared Spectroscopy