Wet Cupping (AlHijamah); Double Versus Single Cupping Technique

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02631382
• Other study ID #: NCCAM - TRIAL - CUPPING2
• Status: Completed
• Phase: N/A
• First received: December 6, 2015
• Last updated: September 20, 2016
• Start date: November 2015
• Est. completion date: May 2016

Study information

• Verified date: December 2015
• Source: National Center for Complementary and Alternative Medicine, Saudi Arabia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Procedure:
• wet 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.

Locations

Country	Name	City	State
Saudi Arabia	King Fahad Hospital	Jeddah
Saudi Arabia	King Fahad Hospital	Madinah

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Complementary and Alternative Medicine, Saudi Arabia

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient satisfaction using the Integrative Medicine Patient Satisfaction Scale (IMPSS)	5 grade scales will be compared to a five grade scales of expectation measured before intervention	up to 14 days	No
Primary	Pain Numeric rating scale (NRS) before and after intervention	numeric pain scale to be measured before intervention then two weeks after	14 DAYS	No
Secondary	pain: McGill, Persistent Pain Intensity (PPI)	before intervention and two weeks later	14 days	No
Secondary	functioning (Disability) using the Oswestry Disability Questionnaire (ODQ)	functionality will be measured using the questionnaire and compared two weeks after intervention	14 days	No
Secondary	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	Yes