Low Back Pain
Conditions
Keywords
wet cupping Saudi Arabia
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.
Interventions
PROCEDUREwet cupping
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.
Sponsors
National Center for Complementary and Alternative Medicine, Saudi Arabia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Numeric rating scale (NRS) before and after intervention | 14 DAYS | numeric pain scale to be measured before intervention then two weeks after |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pain: McGill, Persistent Pain Intensity (PPI) | 14 days | before intervention and two weeks later |
| functioning (Disability) using the Oswestry Disability Questionnaire (ODQ) | 14 days | functionality will be measured using the questionnaire and compared two weeks after intervention |
| the Safety of the two wet cupping techniques, by collecting safety data after two weeks of the intervention | up to 14 days | using the WHO guidelines for classification of adverse events |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction using the Integrative Medicine Patient Satisfaction Scale (IMPSS) | up to 14 days | 5 grade scales will be compared to a five grade scales of expectation measured before intervention |
Countries
Saudi Arabia
Outcome results
None listed