NCT01913574

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

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

March 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

December 22, 2021

Status Verified

December 1, 2021

Enrollment Period

1 year

First QC Date

July 29, 2013

Last Update Submit

December 7, 2021

Conditions

Abdominal Pain

Outcome Measures

Primary Outcomes (1)

  • 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.

    Change from baseline to 2 weeks

Secondary Outcomes (1)

  • Analgesic drug consumption

    Change from baseline to 2 weeks

Study Arms (2)

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).

Device: AcupunctureProcedure: 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.

Procedure: Neurolytic celiac plexus block (NCPB)

Interventions

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.

Acupuncture & NCPB
Neurolytic celiac plexus block (NCPB)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.

Acupuncture & NCPBNCPB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Daegu Catholic University Medical Center

Daegu, Kyungsangbukdo, South Korea

Location

MeSH Terms

Conditions

Abdominal Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Jeong-Chul Seo, KMD, Ph.D

    Comprehensive and Integrative Medicine Institute

    PRINCIPAL INVESTIGATOR

  • Min-Ah Gwak, KMD, Ph.D

    Daegu Oriental Hospital of Daegu Haany University

    PRINCIPAL INVESTIGATOR

  • Seong_Hoon Park, KMD

    Comprehensive and Integrative Medicine Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of anesthesiolgy

Study Record Dates

First Submitted

July 29, 2013

First Posted

August 1, 2013

Study Start

March 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

December 22, 2021

Record last verified: 2021-12

Locations

KR(1)