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

Abdominal Pain Clinical Trial

Official title:

Pilot Study of Acupuncture to Alleviate the Upper Abdominal Pain of Cancer Patients Treated With Neurolytic Celiac Plexus Block

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01913574
• Other study ID #: CIMI-13-01-09
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: March 2014

Study information

• Verified date: December 2021
• Source: Daegu Catholic University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Pain

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Daegu Catholic University Medical Center	Daegu	Kyungsangbukdo

Sponsors (1)

Lead Sponsor	Collaborator
Daegu Catholic University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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