Wet Cupping (AlHijamah); Double Versus Single Cupping Technique

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

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

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Procedure: wet cupping

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Jeddah, Saudi Arabia
    • King Fahad Hospital
  • Madinah, Saudi Arabia
    • King Fahad Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: wet cupping : double cupping; wet cupping: (traditional cupping technique): cupping (suction) - Scarification - cupping (suction)	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.; Other Names: Hijamah; wet cupping device
Experimental: wet cupping: single cupping; wet cupping:(Asian cupping): Puncture by needles then cupping (suction):	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.; Other Names: Hijamah; wet cupping device

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National Center for Complementary and Alternative Medicine, Saudi Arabia
• Investigators: Principal Investigator: Sulaiman AlEidi, MBBS, NCCAM , MOH, Riyadh, Saudi Arabia; Study Chair: Mohamed Khalil, MD, NCCAM.MOH; Study Chair: Ashry Gad Mohamed, MD, King Saud University

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: December 6, 2015
• First Submitted That Met QC Criteria: December 12, 2015
• First Posted (Estimate): December 16, 2015

Study Record Updates

• Last Update Posted (Estimate): September 22, 2016
• Last Update Submitted That Met QC Criteria: September 20, 2016
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: wet cupping Saudi Arabia
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: NCCAM - TRIAL - CUPPING2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided