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

Not Applicable

Completed

• Conditions: Abdominal Pain
• Interventions: Procedure: Neurolytic celiac plexus block (NCPB); Device: Acupuncture

• Registration Number: NCT01913574
• Lead Sponsor: Daegu Catholic University Medical Center

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.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-07-29
• Study First Submitted QC: 2013-07-30
• Study First Posted: 2013-08-01
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-07
• Last Update Posted: 2021-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NCPB	Neurolytic celiac plexus block (NCPB)	The NCPB alone will be applied to the patients in this group, once at the start of the trial.
Acupuncture & NCPB	Acupuncture	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).
Acupuncture & NCPB	Neurolytic celiac plexus block (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).

Primary Outcome Measures

Name	Time	Method
Visual analogue scale(VAS)	Change from baseline to 2 weeks	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

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

Trial Locations

Locations (1)

Daegu Catholic University Medical Center; 🇰🇷 Daegu, Kyungsangbukdo, Korea, Republic of