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

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

Study Overview

• Status: Completed
• Conditions: Abdominal Pain
• Intervention / Treatment: Device: Acupuncture; Procedure: Neurolytic celiac plexus block (NCPB)

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Kyungsangbukdo
    • Daegu, Kyungsangbukdo, Korea, Republic of
      • Daegu Catholic University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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).	Device: 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.; Procedure: 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.
ACTIVE_COMPARATOR: NCPB; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesic drug consumption	Drug consumption per day will be documented before treatment, after 1 week, after 2 week, and 1 week follow-up.	Change from baseline to 2 weeks

Collaborators and Investigators

• Sponsor: Daegu Catholic University Medical Center
• Investigators: Principal Investigator: Jeong-Chul Seo, KMD, Ph.D, Comprehensive and Integrative Medicine Institute; Principal Investigator: Seong_Hoon Park, KMD, Comprehensive and Integrative Medicine Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2013
• Primary Completion (ACTUAL): March 1, 2014
• Study Completion (ACTUAL): March 1, 2014

Study Registration Dates

• First Submitted: July 29, 2013
• First Submitted That Met QC Criteria: July 30, 2013
• First Posted (ESTIMATE): August 1, 2013

Study Record Updates

• Last Update Posted (ACTUAL): December 22, 2021
• Last Update Submitted That Met QC Criteria: December 7, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Abdominal Pain
• Other Study ID Numbers: CIMI-13-01-09