NCT00925951

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 22, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Last Updated

January 5, 2010

Status Verified

June 1, 2009

Enrollment Period

6 months

First QC Date

June 19, 2009

Last Update Submit

January 4, 2010

Conditions

Low Back Pain

Keywords

Persistent Non-specific Low Back Painwet cuppingcuppingNumerical Rating Scale

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • Safety measurement

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

Study Arms (2)

Wet Cupping

EXPERIMENTAL
Device: Wet CuppingDrug: Acetaminophen

Waiting Control

NO INTERVENTION

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

Interventions

Wet CuppingDEVICE

Wet cupping (Seongho trade \& company, Korea) will be practiced at two selected points (among the 6 acupoints, left or right BL23, BL24, BL25)

Also known as: Disposable wet cupping cup, Seongho trade & company, Korea
Wet Cupping
AcetaminophenDRUG

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

Waiting ControlWet Cupping

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients who have had non-specific low back pains at least 12 weeks now.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Daejeon, Chungchong, 302-869, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 21663617DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Sun-mi Choi, Doctor

    Korea Institute of Oriental Medicine (KIOM)

    STUDY CHAIR

  • Jong-In Kim, Doctor

    Korea Institue of Oriental Medicine (KIOM)

    STUDY DIRECTOR

  • Tae-hun Kim, Doctor

    Korea Institue of Oriental Medicine (KIOM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

June 19, 2009

First Posted

June 22, 2009

Study Start

June 1, 2009

Primary Completion

December 1, 2009

Last Updated

January 5, 2010

Record last verified: 2009-06

Locations

KR(1)