Clinical trial NCT02631382: Wet Cupping (AlHijamah); Double Versus Single Cupping Technique
Official title: Wet Cupping (AlHijamah); Double Versus Single Cupping Technique in Chronic Low Back Pain Patients: Randomized Comparative Clinical Trial, Pilot Study Saudi Arabia, 2015
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: wet cupping Saudi Arabia
Lead sponsor: National Center for Complementary and Alternative Medicine, Saudi Arabia
Sponsor class: OTHER_GOV
First posted: 2015-12-16
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Numeric rating scale (NRS) before and after intervention
timeFrame: 14 DAYS
Secondary outcomes:
measure: pain: McGill, Persistent Pain Intensity (PPI)
timeFrame: 14 days
measure: functioning (Disability) using the Oswestry Disability Questionnaire (ODQ)
timeFrame: 14 days
measure: the Safety of the two wet cupping techniques, by collecting safety data after two weeks of the intervention
timeFrame: up to 14 days
Other outcomes:
measure: Patient satisfaction using the Integrative Medicine Patient Satisfaction Scale (IMPSS)
timeFrame: up to 14 days
Locations:
city: Jeddah
country: Saudi Arabia
facility: King Fahad Hospital
city: Madinah
country: Saudi Arabia
facility: King Fahad Hospital
Study officials:
affiliation: NCCAM , MOH, Riyadh, Saudi Arabia
name: Sulaiman AlEidi, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: NCCAM.MOH
name: Mohamed Khalil, MD
role: STUDY_CHAIR
affiliation: King Saud University
name: Ashry Gad Mohamed, MD
role: STUDY_CHAIR
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