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

N/ACompletedNCT01913574

Daegu Catholic University Medical Center14 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Abdominal Pain

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.

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Daegu Catholic University Medical Center

Daegu, Kyungsangbukdo, South Korea

Outcomes

Primary Outcomes

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.

Time frame: Change from baseline to 2 weeks

Secondary Outcomes

Analgesic drug consumption

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

Data from ClinicalTrials.gov

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