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Completed

NCT Number: NCT00925951

The Effectiveness of Wet Cupping on Persistent Non-specific Low Back Pain

The hypothesis of this study is that the improvement of Numeric Rating Scale (NRS) for Pain at the end of the study will be greater in the Wet Cupping Treatment group than in the Waiting Control group.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Korea Institue of Oriental Medicine (KIOM), Doonsan Oriental Hospital of Daejeon University

Daejeon, Chungchong, 302-869, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who have had non-specific low back pains at least 12 weeks now.

Exclusion criteria

  • Patients who have low back pain due to specific and known etiological causes (infection, tumor, osteoporosis, ankylosing spondylitis, fracture, inflammatory process, radicular syndrome, cauda equinal syndrome).
  • Patients who are inappropriate to the wet cupping treatment.
  • AIDS, Active Hepatitis, Tuberculosis, Syphilis
  • Patients who regularly take anticoagulants, antiplatelet drugs
  • Anemia, thrombocytopenia
  • Hemorrhagic disease like hemophilia
  • Diabetes
  • Severe cardiovascular disease
  • Kidney diseases (renal failure, chronic renal disease)
  • Patients who have experiences of wet cupping treatment during last 3 months.
  • Patients who have had treatment for low back pain during last 2 weeks.
  • Patients who are in pregnancy or have plan to conception.
  • Patients who have vertebra surgery or have plan of surgery.
  • Patients who are inappropriate to join this trial judged by the radiologists or specialists.

Treatment and study plan

Wet Cupping

Device

Wet cupping (Seongho trade & company, Korea) will be practiced at two selected points (among the 6 acupoints, left or right BL23, BL24, BL25)

Other names: Disposable wet cupping cup, Seongho trade & company, Korea

Acetaminophen

Drug

Acetaminophen 500 mg tablets will be offered to both of the wet cupping group and waiting group for relieving severe pain.

Primary outcomes

  1. Numeric Rating Scale (NRS) for pain

    Time frame: study group: at base line, post-treatment, 4 weeks later after allocation; control group: at base line, 4 weeks later after allocation

Secondary outcomes

  1. Present Pain Intensity Scale of the McGill Pain Questionaire (PPI)

    Time frame: study group: at base line, post-treatment, 4 weeks later after allocation; control group: at base line, 4 weeks later after allocation

  2. Oswestry Disability Questionnaire (ODQ)

    Time frame: study group: at base line, post-treatment, 4 weeks later after allocation; control group: at base line, 4 weeks later after allocation

  3. Medication Quantification Scale (MQS)

    Time frame: study group: at base line, post-treatment, 4 weeks later after allocation; control group: at base line, 4 weeks later after allocation

  4. General Assessment of Doctors and Subjects

    Time frame: study group: at base line, post-treatment, 4 weeks later after allocation; control group: at base line, 4 weeks later after allocation

  5. Safety measurement

    Time frame: study group: at base line, post-treatment, 4 weeks later after allocation; control group: at base line, 4 weeks later after allocation

Sponsors and collaborators

Lead sponsor

Korea Institute of Oriental Medicine

Other Gov

Registry information

Official study title

The Effectiveness of Wet Cupping on Persistent Non-specific Low Back Pain: A Randomized, Waiting-list Controlled, Open-label, Parallel-group Pilot Study

Important dates

Study start
2009
Primary completion
2009
First posted
Jun 22, 2009
Registry last updated
Jan 5, 2010

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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