Abdominal PainNCT01913574
Efficacy Study of Acupuncture to Treat the Upper Abdominal Pain of Cancer Patients
A study testing Acupuncture and Neurolytic celiac plexus block (NCPB) in people with Abdominal Pain, run by Daegu Catholic University Medical Center at 1 site in South Korea.
Trial summary
This study is to investigate the effectiveness of acupuncture for alleviating the upper abdominal pain of cancer patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Pain
- What is being tested?
- Acupuncture and Neurolytic celiac plexus block (NCPB)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2013to Mar 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years
- Upper abdominal pain VAS ≥ 5
- Unresectable abdominal malignancy, moderate or severe abdominal pain poorly controlled with pharmacotherapy.
- All patients had advanced cancer diagnosed by histological/cytological examination
- Follow-up possible during the clinical trial
- Written informed consent voluntarily
Who cannot join
- Patient with uncorrectable coagulopathy
- Patient with allergy to local anesthesics or alcohol..
- Previous NCPB or had implanted epidural or intrathecal analgesic therapy
- Inability to lie prone
- Disease encasing the celiac plexus on computed Tomography scan
- Patients with psychiatric diseases that could have affected the study assessments
Show all 9Show fewer
- Significant renal or hepatic disease
- Inability to comprehend or express oneself in the Korean language
- Refusal to participate in the trial or to provide informed consent
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Daegu Catholic University Medical Center
Daegu, Kyungsangbukdo
About this study
Official title: Pilot Study of Acupuncture to Alleviate the Upper Abdominal Pain of Cancer Patients Treated With Neurolytic Celiac Plexus Block
This study is to investigate the effectiveness of acupuncture for alleviating the upper abdominal pain of cancer patients
Read the detailed description
Neurolytic celiac plexus block (NCPB) is a commonly performed procedure in patients with intractable pain due to malignancies involving the upper and mid abdomen. Recently, acupuncture is used as one of alternative interventions to treat cancer-related pains. This pilot study aims to investigate the effectiveness of pain-relief of acupuncture via comparing acupuncture plus NCPB with NCPB alone. Total 14 cancer patients with NCPB will be randomized into two groups of acupuncture and control.
- Conditions
- Abdominal Pain
- Being tested
- Acupuncture, Neurolytic celiac plexus block (NCPB)
- Medical subject headings
- Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
Acupuncture is applied three times a week for 20 minutes for 2 weeks (total 6 sessions). 9 Acupuncture points, CV12, CV13, P6, SP4, ST36(bilateral),LI4 (bilateral), LR3 (bilateral), ST34 (bilateral), and GB21(bilateral) are used, and CV12, CV13, ST36, and LR3 are electro-stimulated.
Neurolytic celiac plexus block (NCPB)Procedure or surgery
An anaesthetic test is performed injecting 2ml mepivacaine. After assessing the efficacy and safety of this test, 10 ml of absolute alcohol is injected via each needle.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture & NCPB | Experimental | The NCPB will be administered once at the start of the trial and the acupuncture will be performed 3 times per week for 2 weeks (6 times in total). Receives: Device: Acupuncture; Procedure: Neurolytic celiac plexus block (NCPB) |
| NCPB | Active comparator | The NCPB alone will be applied to the patients in this group, once at the start of the trial. Receives: Procedure: Neurolytic celiac plexus block (NCPB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale(VAS)
The patients will be required to document 100mm pain VAS, where '0' represents 'no pain' and '100', 'unbearable pain'. The change of pain will be reported by comparing the mean VAS before treatment, after 1 week, after 2 week, and 1 week follow-up.
Measured: Change from baseline to 2 weeks
Secondary outcomes (1)
Analgesic drug consumption
Drug consumption per day will be documented before treatment, after 1 week, after 2 week, and 1 week follow-up.
Measured: Change from baseline to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daegu Catholic University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Yong Jung, Daegu Catholic University Medical Center
- Investigators
- Jeong-Chul Seo, KMD, Ph.D, Principal investigator, Comprehensive and Integrative Medicine InstituteMin-Ah Gwak, KMD, Ph.D, Principal investigator, Daegu Oriental Hospital of Daegu Haany UniversitySeong_Hoon Park, KMD, Principal investigator, Comprehensive and Integrative Medicine Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01913574
- Sponsor's protocol ID
- CIMI-13-01-09
- Status last verified
- Dec 2021
- First submitted
- 29 Jul 2013
- Last updated
- 22 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Acupuncture to Alleviate the Upper Abdominal Pain of Cancer Patients Treated With Neurolytic Celiac Plexus Block
- ClinicalTrials.gov ID
- NCT01913574
- Acronym / sponsor ID
- CIMI-13-01-09
- Conditions
- Abdominal Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Daegu Catholic University Medical CenterUniversity, hospital or other
- Study start
- Mar 2013 (actual)
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 1 Aug 2013 (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.
This study is to investigate the effectiveness of acupuncture for alleviating the upper abdominal pain of cancer patients
Detailed description
Neurolytic celiac plexus block (NCPB) is a commonly performed procedure in patients with intractable pain due to malignancies involving the upper and mid abdomen. Recently, acupuncture is used as one of alternative interventions to treat cancer-related pains. This pilot study aims to investigate the effectiveness of pain-relief of acupuncture via comparing acupuncture plus NCPB with NCPB alone. Total 14 cancer patients with NCPB will be randomized into two groups of acupuncture and control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture & NCPB | Experimental | Device: Acupuncture, Procedure: Neurolytic celiac plexus block (NCPB)The NCPB will be administered once at the start of the trial and the acupuncture will be performed 3 times per week for 2 weeks (6 times in total). |
| NCPB | Active comparator | Procedure: Neurolytic celiac plexus block (NCPB)The NCPB alone will be applied to the patients in this group, once at the start of the trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age over 18 years
- Upper abdominal pain VAS ≥ 5
- Unresectable abdominal malignancy, moderate or severe abdominal pain poorly controlled with pharmacotherapy.
- All patients had advanced cancer diagnosed by histological/cytological examination
- Follow-up possible during the clinical trial
Key exclusion criteria (9 listed)
- Patient with uncorrectable coagulopathy
- Patient with allergy to local anesthesics or alcohol..
- Previous NCPB or had implanted epidural or intrathecal analgesic therapy
- Inability to lie prone
- Disease encasing the celiac plexus on computed Tomography scan
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 |
|---|---|---|
| AcupunctureAcupuncture is applied three times a week for 20 minutes for 2 weeks (total 6 sessions). 9 Acupuncture points, CV12, CV13, P6, SP4, ST36(bilateral),LI4 (bilateral), LR3 (bilateral), ST34 (bilateral), and GB21(bilateral) are used, and CV12, CV13, ST36, and LR3 are electro-stimulated. | Device | Acupuncture & NCPB |
| Neurolytic celiac plexus block (NCPB)An anaesthetic test is performed injecting 2ml mepivacaine. After assessing the efficacy and safety of this test, 10 ml of absolute alcohol is injected via each needle. | Procedure or surgery | Acupuncture & NCPB, NCPB |
Primary outcome
Visual analogue scale(VAS)
Time frame: Change from baseline to 2 weeks
The patients will be required to document 100mm pain VAS, where '0' represents 'no pain' and '100', 'unbearable pain'. The change of pain will be reported by comparing the mean VAS before treatment, after 1 week, after 2 week, and 1 week follow-up.
1 secondary outcome
Analgesic drug consumption
Time frame: Change from baseline to 2 weeks
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 22 Dec 2021.
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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.
Jeong-Chul Seo, KMD, Ph.D principal investigator
Comprehensive and Integrative Medicine Institute
Min-Ah Gwak, KMD, Ph.D principal investigator
Daegu Oriental Hospital of Daegu Haany University
Seong_Hoon Park, KMD principal investigator
Comprehensive and Integrative Medicine Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and Neurolytic celiac plexus block (NCPB) in people with Abdominal Pain, run by Daegu Catholic University Medical Center 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 6 inclusion and 9 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 22 Dec 2021. 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?
Visual analogue scale(VAS) (time frame: Change from baseline to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Dec 2021.