Clinical trial NCT00925951: 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
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Persistent Non-specific Low Back Pain
wet cupping
cupping
Numerical Rating Scale
Lead sponsor: Korea Institute of Oriental Medicine
Sponsor class: OTHER_GOV
First posted: 2009-06-22
Enrollment: 37
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Numeric Rating Scale (NRS) for pain
timeFrame: study group: at base line, post-treatment, 4 weeks later after allocation; control group: at base line, 4 weeks later after allocation
Secondary outcomes:
measure: Present Pain Intensity Scale of the McGill Pain Questionaire (PPI)
timeFrame: study group: at base line, post-treatment, 4 weeks later after allocation; control group: at base line, 4 weeks later after allocation
measure: Oswestry Disability Questionnaire (ODQ)
timeFrame: study group: at base line, post-treatment, 4 weeks later after allocation; control group: at base line, 4 weeks later after allocation
measure: Medication Quantification Scale (MQS)
timeFrame: study group: at base line, post-treatment, 4 weeks later after allocation; control group: at base line, 4 weeks later after allocation
measure: General Assessment of Doctors and Subjects
timeFrame: study group: at base line, post-treatment, 4 weeks later after allocation; control group: at base line, 4 weeks later after allocation
measure: Safety measurement
timeFrame: study group: at base line, post-treatment, 4 weeks later after allocation; control group: at base line, 4 weeks later after allocation
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Korea Institue of Oriental Medicine (KIOM), Doonsan Oriental Hospital of Daejeon University
state: Chungchong
Study officials:
affiliation: Korea Institute of Oriental Medicine (KIOM)
name: Sun-mi Choi, Doctor
role: STUDY_CHAIR
affiliation: Korea Institue of Oriental Medicine (KIOM)
name: Jong-In Kim, Doctor
role: STUDY_DIRECTOR
affiliation: Korea Institue of Oriental Medicine (KIOM)
name: Tae-hun Kim, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
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.