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

January 4, 2010 updated by: Korea Institute of Oriental Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Chungchong
      • Daejeon, Chungchong, Korea, Republic of, 302-869
        • Korea Institue of Oriental Medicine (KIOM), Doonsan Oriental Hospital of Daejeon University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

June 19, 2009

First Submitted That Met QC Criteria

June 19, 2009

First Posted (Estimate)

June 22, 2009

Study Record Updates

Last Update Posted (Estimate)

January 5, 2010

Last Update Submitted That Met QC Criteria

January 4, 2010

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KI0905

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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