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

NCT ID: NCT01913574

Last Updated: 2021-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-03-31

Brief Summary

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This study is to investigate the effectiveness of acupuncture for alleviating the upper abdominal pain of cancer patients

Detailed Description

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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

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Abdominal Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Acupuncture & 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).

Group Type EXPERIMENTAL

Acupuncture

Intervention Type DEVICE

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)

Intervention Type PROCEDURE

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.

NCPB

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

Group Type ACTIVE_COMPARATOR

Neurolytic celiac plexus block (NCPB)

Intervention Type PROCEDURE

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.

Interventions

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Acupuncture

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 DEVICE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daegu Catholic University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jin Yong Jung

Department of anesthesiolgy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeong-Chul Seo, KMD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Comprehensive and Integrative Medicine Institute

Min-Ah Gwak, KMD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Daegu Oriental Hospital of Daegu Haany University

Seong_Hoon Park, KMD

Role: PRINCIPAL_INVESTIGATOR

Comprehensive and Integrative Medicine Institute

Locations

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Daegu Catholic University Medical Center

Daegu, Kyungsangbukdo, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CIMI-13-01-09

Identifier Type: -

Identifier Source: org_study_id