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Completed

NCT Number: NCT01913574

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Daegu Catholic University Medical Center

Daegu, Kyungsangbukdo, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

acupuncture

Device

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.

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Daegu Catholic University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 1, 2013
Registry last updated
Dec 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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