Wet Cupping (AlHijamah); Double Versus Single Cupping Technique

Study Overview
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Brief Summary
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Randomized clinical trial to compare the effectiveness and safety of double (traditional) versus single (Asian) cupping techniques in chronic low back pain.

Detailed Description
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Chronic Low Back Pain is a very common pain disorder in the primary care. As in many chronic pain conditions, patients are usually asking for alternative options, especially local traditional and therapies including wet cupping, to replace the long-term use of painkillers. The majority of the wet cupping trials conducted abroad used different techniques, which is different from our local traditional wet cupping technique. This study can identify the technique that is more efficacious in reducing pain, prolonging the pain relieve period, and decrease patient dependence on painkillers in chronic low back pain.The aim of this study is to compare the effectiveness and safety of double (traditional) versus single (Asian) cupping techniques in chronic low back pain. This a randomized comparative effectiveness pilot clinical trial. After taking written informed consent, patient with chronic low back pain will be randomized into two groups, one group to receive wet cupping therapy with the Traditional double technique, the other group to receive it with the Asian single technique. Numeric Rating Scale, Present Pain Intensity and Oswestry Disability Questionnaire will be used to measure the outcome before and after the intervention, one week after the intervention, then two weeks after. Wilcoxon rank sum test for the continuous dependent data analysis and the analysis of covariance ANCOVA, to compare both groups mean scores will be used. The outcome baseline for each score will be used as the covariate. Chi square or Fisher's exact test will be used to compare categorical data with Minimal Clinical Improvement Difference within and between the two groups.

Official Title
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Wet Cupping (AlHijamah); Double Versus Single Cupping Technique in Chronic Low Back Pain Patients: Randomized Comparative Clinical Trial, Pilot Study Saudi Arabia, 2015

Conditions
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Low Back Pain

Intervention / Treatment
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* Procedure: wet cupping


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and Female Age equal or more than 18 years up to 60 years Chronic low back pain (at least the duration ≥ 3 months) Not on anti-inflammatory or pain killers for the last 15 days. Exclusion Criteria: Patients received wet-cupping therapy before in the last three months Patients who have low back pain due to specific and known etiological causes (infection, tumor, osteoporosis, ankylosing spondylitis, fracture, inflammatory process, radicular syndrome, and cauda equinal syndrome) Patients who are inappropriate to the wet cupping treatment (AIDS, Hepatitis, Tuberculosis, Syphilis. The referring physicians will be advised to exclude those patients) Patients currently receiving any anticoagulant, antiplatelet medications Anemia, thrombocytopenia, Coagulopathy or Hemorrhagic disease like hemophilia Had undergone a surgery, or had bleeding injury, or had blood donation Uncontrolled hypertension, Ischemic heart disease, previous transient ischemic attack or stroke Diabetes, known renal and / or hepatic diseases Patients who are in pregnancy or have plan to conception Previously or currently drug addicts Any other severe disease or disabling medical condition

Ages Eligible for Study
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Minimum Age: 18 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: wet cupping : double cupping<br>wet cupping: (traditional cupping technique): cupping (suction) - Scarification - cupping (suction) | Procedure: wet cupping<br>* In double cupping (traditional technique): Cupping (suction) then scarification then cupping (suction). In single cupping (Asian): puncture using auto lancet then cupping (suction). In both techniques 4 out of 6 acupoints (BL23, BL24, BL25 bilateral) will be selected.<br>* Other names: wet cupping device;|
| Experimental: wet cupping: single cupping<br>wet cupping:(Asian cupping): Puncture by needles then cupping (suction): | Procedure: wet cupping<br>* In double cupping (traditional technique): Cupping (suction) then scarification then cupping (suction). In single cupping (Asian): puncture using auto lancet then cupping (suction). In both techniques 4 out of 6 acupoints (BL23, BL24, BL25 bilateral) will be selected.<br>* Other names: wet cupping device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Numeric rating scale (NRS) before and after intervention | numeric pain scale to be measured before intervention then two weeks after | 14 DAYS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain: McGill, Persistent Pain Intensity (PPI) | before intervention and two weeks later | 14 days | 
| functioning (Disability) using the Oswestry Disability Questionnaire (ODQ) | functionality will be measured using the questionnaire and compared two weeks after intervention | 14 days | 
| the Safety of the two wet cupping techniques, by collecting safety data after two weeks of the intervention | using the WHO guidelines for classification of adverse events | up to 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wet cupping Saudi Arabia