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

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00925951
• Other study ID #: KI0905
• Status: Completed
• Phase: N/A
• First received: June 19, 2009
• Last updated: January 4, 2010
• Start date: June 2009

Study information

• Verified date: June 2009
• Source: Korea Institute of Oriental Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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)

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

Locations

Country	Name	City	State
Korea, Republic of	Korea Institue of Oriental Medicine (KIOM), Doonsan Oriental Hospital of Daejeon University	Daejeon	Chungchong

Sponsors (1)

Lead Sponsor	Collaborator
Korea Institute of Oriental Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Rating Scale (NRS) for pain		study group: at base line, post-treatment, 4 weeks later after allocation; control group: at base line, 4 weeks later after allocation	No
Secondary	Present Pain Intensity Scale of the McGill Pain Questionaire (PPI)		study group: at base line, post-treatment, 4 weeks later after allocation; control group: at base line, 4 weeks later after allocation	Yes
Secondary	Oswestry Disability Questionnaire (ODQ)		study group: at base line, post-treatment, 4 weeks later after allocation; control group: at base line, 4 weeks later after allocation	Yes
Secondary	Medication Quantification Scale (MQS)		study group: at base line, post-treatment, 4 weeks later after allocation; control group: at base line, 4 weeks later after allocation	Yes
Secondary	General Assessment of Doctors and Subjects		study group: at base line, post-treatment, 4 weeks later after allocation; control group: at base line, 4 weeks later after allocation	Yes
Secondary	Safety measurement		study group: at base line, post-treatment, 4 weeks later after allocation; control group: at base line, 4 weeks later after allocation	Yes