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Efficacy Study of Acupuncture to Treat the Upper Abdominal Pain of Cancer Patients

Primary Purpose

Abdominal Pain

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Acupuncture
Neurolytic celiac plexus block (NCPB)
Sponsored by
Daegu Catholic University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • Daegu Catholic University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Acupuncture & NCPB

NCPB

Arm Description

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).

The NCPB alone will be applied to the patients in this group, once at the start of the trial.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Analgesic drug consumption
Drug consumption per day will be documented before treatment, after 1 week, after 2 week, and 1 week follow-up.

Full Information

First Posted
July 29, 2013
Last Updated
December 7, 2021
Sponsor
Daegu Catholic University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01913574
Brief Title
Efficacy Study of Acupuncture to Treat the Upper Abdominal Pain of Cancer Patients
Official Title
Pilot Study of Acupuncture to Alleviate the Upper Abdominal Pain of Cancer Patients Treated With Neurolytic Celiac Plexus Block
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
March 2013 (Actual)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Daegu Catholic University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture & NCPB
Arm Type
Experimental
Arm Description
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).
Arm Title
NCPB
Arm Type
Active Comparator
Arm Description
The NCPB alone will be applied to the patients in this group, once at the start of the trial.
Intervention Type
Device
Intervention Name(s)
Acupuncture
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Neurolytic celiac plexus block (NCPB)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual analogue scale(VAS)
Description
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.
Time Frame
Change from baseline to 2 weeks
Secondary Outcome Measure Information:
Title
Analgesic drug consumption
Description
Drug consumption per day will be documented before treatment, after 1 week, after 2 week, and 1 week follow-up.
Time Frame
Change from baseline to 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong-Chul Seo, KMD, Ph.D
Organizational Affiliation
Comprehensive and Integrative Medicine Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Min-Ah Gwak, KMD, Ph.D
Organizational Affiliation
Daegu Oriental Hospital of Daegu Haany University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Seong_Hoon Park, KMD
Organizational Affiliation
Comprehensive and Integrative Medicine Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Daegu Catholic University Medical Center
City
Daegu
State/Province
Kyungsangbukdo
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Efficacy Study of Acupuncture to Treat the Upper Abdominal Pain of Cancer Patients

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