search
Back to results

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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Wet Cupping
Acetaminophen
Sponsored by
Korea Institute of Oriental Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Persistent Non-specific Low Back Pain, wet cupping, cupping, Numerical Rating Scale

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Wet Cupping

Waiting Control

Arm Description

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).

Outcomes

Primary Outcome Measures

Numeric Rating Scale (NRS) for pain

Secondary Outcome Measures

Present Pain Intensity Scale of the McGill Pain Questionaire (PPI)
Oswestry Disability Questionnaire (ODQ)
Medication Quantification Scale (MQS)
General Assessment of Doctors and Subjects
Safety measurement

Full Information

First Posted
June 19, 2009
Last Updated
January 4, 2010
Sponsor
Korea Institute of Oriental Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT00925951
Brief Title
The Effectiveness of Wet Cupping on Persistent Non-specific Low Back Pain
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 Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Korea Institute of Oriental Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Persistent Non-specific Low Back Pain, wet cupping, cupping, Numerical Rating Scale

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Wet Cupping
Arm Type
Experimental
Arm Title
Waiting Control
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Wet Cupping
Other Intervention Name(s)
Disposable wet cupping cup, Seongho trade & company, Korea
Intervention Description
Wet cupping (Seongho trade & company, Korea) will be practiced at two selected points (among the 6 acupoints, left or right BL23, BL24, BL25)
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Intervention Description
Acetaminophen 500 mg tablets will be offered to both of the wet cupping group and waiting group for relieving severe pain.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sun-mi Choi, Doctor
Organizational Affiliation
Korea Institute of Oriental Medicine (KIOM)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jong-In Kim, Doctor
Organizational Affiliation
Korea Institue of Oriental Medicine (KIOM)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tae-hun Kim, Doctor
Organizational Affiliation
Korea Institue of Oriental Medicine (KIOM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea Institue of Oriental Medicine (KIOM), Doonsan Oriental Hospital of Daejeon University
City
Daejeon
State/Province
Chungchong
ZIP/Postal Code
302-869
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
21663617
Citation
Kim JI, Kim TH, Lee MS, Kang JW, Kim KH, Choi JY, Kang KW, Kim AR, Shin MS, Jung SY, Choi SM. Evaluation of wet-cupping therapy for persistent non-specific low back pain: a randomised, waiting-list controlled, open-label, parallel-group pilot trial. Trials. 2011 Jun 10;12:146. doi: 10.1186/1745-6215-12-146.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs