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

This study has been completed.
Sponsor:
Information provided by:
Korea Institute of Oriental Medicine
ClinicalTrials.gov Identifier:
NCT00925951
First received: June 19, 2009
Last updated: January 4, 2010
Last verified: June 2009
  Purpose

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 Intervention
Low Back Pain
Device: Wet Cupping
Drug: Acetaminophen

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Korea Institute of Oriental Medicine:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 37
Study Start Date: June 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00925951

Locations
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
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

No publications provided by Korea Institute of Oriental Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kim Ki-ok, Korea Institute of Oriental Medicine
ClinicalTrials.gov Identifier: NCT00925951     History of Changes
Other Study ID Numbers: KI0905
Study First Received: June 19, 2009
Last Updated: January 4, 2010
Health Authority: South Korea: Institutional Review Board

Keywords provided by Korea Institute of Oriental Medicine:
Persistent Non-specific Low Back Pain
wet cupping
cupping
Numerical Rating Scale

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics

ClinicalTrials.gov processed this record on September 30, 2014