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Completed

NCT Number: NCT02631382

Wet Cupping (AlHijamah); Double Versus Single Cupping Technique

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Fahad Hospital, Jeddah, Saudi Arabia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wet Cupping

Procedure

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

Primary outcomes

  1. Pain Numeric rating scale (NRS) before and after intervention

    Time frame: 14 DAYS

    numeric pain scale to be measured before intervention then two weeks after

Secondary outcomes

  1. pain: McGill, Persistent Pain Intensity (PPI)

    Time frame: 14 days

    before intervention and two weeks later

  2. functioning (Disability) using the Oswestry Disability Questionnaire (ODQ)

    Time frame: 14 days

    functionality will be measured using the questionnaire and compared two weeks after intervention

  3. the Safety of the two wet cupping techniques, by collecting safety data after two weeks of the intervention

    Time frame: up to 14 days

    using the WHO guidelines for classification of adverse events

Other outcomes

  1. Patient satisfaction using the Integrative Medicine Patient Satisfaction Scale (IMPSS)

    Time frame: up to 14 days

    5 grade scales will be compared to a five grade scales of expectation measured before intervention

Sponsors and collaborators

Lead sponsor

National Center for Complementary and Alternative Medicine, Saudi Arabia

Other Gov

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 16, 2015
Registry last updated
Sep 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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