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

Overview

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

Full Title of Study: “Pilot Study of Acupuncture to Alleviate the Upper Abdominal Pain of Cancer Patients Treated With Neurolytic Celiac Plexus Block”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2014

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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).
  • Active Comparator: NCPB
    • The NCPB alone will be applied to the patients in this group, once at the start of the trial.

Clinical Trial Outcome Measures

Primary Measures

  • Visual analogue scale(VAS)
    • Time Frame: 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 Measures

  • Analgesic drug consumption
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Daegu Catholic University Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jin Yong Jung, Department of anesthesiolgy – Daegu Catholic University Medical Center
  • Overall Official(s)
    • Jeong-Chul Seo, KMD, Ph.D, Principal Investigator, Comprehensive and Integrative Medicine Institute
    • Min-Ah Gwak, KMD, Ph.D, Principal Investigator, Daegu Oriental Hospital of Daegu Haany University
    • Seong_Hoon Park, KMD, Principal Investigator, Comprehensive and Integrative Medicine Institute

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.