Low Back PainNCT00925951
The Effectiveness of Wet Cupping on Persistent Non-specific Low Back Pain
A study testing Wet Cupping and Acetaminophen in people with Low Back Pain, run by Korea Institute of Oriental Medicine at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Wet Cupping and Acetaminophen
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2009to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients who have had non-specific low back pains at least 12 weeks now.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Korea Institue of Oriental Medicine (KIOM), Doonsan Oriental Hospital of Daejeon University
Daejeon, Chungchong, 302-869
About this study
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
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.
- Conditions
- Low Back Pain
- Being tested
- Wet Cupping, Acetaminophen
- Keywords
- Persistent Non-specific Low Back Pain, wet cupping, cupping, Numerical Rating Scale
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wet CuppingDevice
Also called Disposable wet cupping cup, Seongho trade & company, Korea
Wet cupping (Seongho trade \& company, Korea) will be practiced at two selected points (among the 6 acupoints, left or right BL23, BL24, BL25)
AcetaminophenDrug
Acetaminophen 500 mg tablets will be offered to both of the wet cupping group and waiting group for relieving severe pain.
| Study group | Role | What they receive |
|---|---|---|
| Wet Cupping | Experimental | Not described Receives: Device: Wet Cupping; Drug: 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). Receives: Drug: Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale (NRS) for pain
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: study group: at base line, post-treatment, 4 weeks later after allocation; control group: at base line, 4 weeks later after allocation
Safety measurement
Measured: study group: at base line, post-treatment, 4 weeks later after allocation; control group: at base line, 4 weeks later after allocation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea Institute of Oriental Medicine
- Sponsor type
- Other government
- Investigators
- Sun-mi Choi, Doctor, Study chair, Korea Institute of Oriental Medicine (KIOM)Jong-In Kim, Doctor, Study director, Korea Institue of Oriental Medicine (KIOM)Tae-hun Kim, Doctor, Principal investigator, Korea Institue of Oriental Medicine (KIOM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00925951
- Sponsor's protocol ID
- KI0905
- Status last verified
- Jun 2009
- First submitted
- 19 Jun 2009
- Last updated
- 5 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21663617
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00925951
- Acronym / sponsor ID
- KI0905
- Conditions
- Low Back Pain
- Keywords
- Persistent Non-specific Low Back Pain, wet cupping, cupping, Numerical Rating Scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Korea Institute of Oriental MedicineOther government
- Study start
- Jun 2009
- Primary completion
- Dec 2009 (actual)
- First posted
- 22 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wet Cupping | Experimental | Device: Wet Cupping, Drug: Acetaminophen |
| Waiting Control | No intervention | Drug: AcetaminophenThey 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). |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients who have had non-specific low back pains at least 12 weeks now.
Key exclusion criteria (14 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wet CuppingAlso: Disposable wet cupping cup, Seongho trade & company, KoreaWet cupping (Seongho trade \& company, Korea) will be practiced at two selected points (among the 6 acupoints, left or right BL23, BL24, BL25) | Device | Wet Cupping |
| AcetaminophenAcetaminophen 500 mg tablets will be offered to both of the wet cupping group and waiting group for relieving severe pain. | Drug | Waiting Control, Wet Cupping |
Primary outcome
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
5 secondary outcomes
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2010.
- Derived from this study: PubMed 21663617Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sun-mi Choi, Doctor study chair
Korea Institute of Oriental Medicine (KIOM)
Jong-In Kim, Doctor study director
Korea Institue of Oriental Medicine (KIOM)
Tae-hun Kim, Doctor principal investigator
Korea Institue of Oriental Medicine (KIOM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wet Cupping and Acetaminophen in people with Low Back Pain, run by Korea Institute of Oriental Medicine at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00925951, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2010.