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

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ClinicalTrials.gov Identifier: NCT00925951
Recruitment Status : Completed
First Posted : June 22, 2009
Last Update Posted : January 5, 2010
Sponsor:
Information provided by:
Korea Institute of Oriental Medicine

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Low Back Pain Device: Wet Cupping Drug: Acetaminophen Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effectiveness of Wet Cupping on Persistent Non-specific Low Back Pain: A Randomized, Waiting-list Controlled, Open-label, Parallel-group Pilot Study
Study Start Date : June 2009
Actual Primary Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
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Arm Intervention/treatment
Experimental: Wet Cupping Device: Wet Cupping
Wet cupping (Seongho trade & company, Korea) will be practiced at two selected points (among the 6 acupoints, left or right BL23, BL24, BL25)
Other Name: Disposable wet cupping cup, Seongho trade & company, Korea

Drug: Acetaminophen
Acetaminophen 500 mg tablets will be offered to both of the wet cupping group and waiting group for relieving severe pain.
No Intervention: Waiting Control
They can't use any other specific treatment except exercises and behavior modification (we'll offer a brochure which includes exercise method and directions about behavior modifications).
 Drug: Acetaminophen
Acetaminophen 500 mg tablets will be offered to both of the wet cupping group and waiting group for relieving severe pain.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00925951


Locations
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Korea, Republic of
Korea Institue of Oriental Medicine (KIOM), Doonsan Oriental Hospital of Daejeon University
Daejeon, Chungchong, Korea, Republic of, 302-869
Sponsors and Collaborators
Korea Institute of Oriental Medicine
Investigators
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Study Chair: Sun-mi Choi, Doctor Korea Institute of Oriental Medicine (KIOM)
Study Director: Jong-In Kim, Doctor Korea Institue of Oriental Medicine (KIOM)
Principal Investigator: Tae-hun Kim, Doctor Korea Institue of Oriental Medicine (KIOM)
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kim Ki-ok, Korea Institute of Oriental Medicine
ClinicalTrials.gov Identifier: NCT00925951    
Other Study ID Numbers: KI0905
First Posted: June 22, 2009    Key Record Dates
Last Update Posted: January 5, 2010
Last Verified: June 2009
Keywords provided by Korea Institute of Oriental Medicine:
Persistent Non-specific Low Back Pain
wet cupping
cupping
Numerical Rating Scale
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Acetaminophen
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics