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

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

Detailed Description
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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.

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

Conditions
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Abdominal Pain

Intervention / Treatment
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* Device: Acupuncture
* Procedure: Neurolytic celiac plexus block (NCPB)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture & NCPB<br>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<br>* 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.<br>Procedure: Neurolytic celiac plexus block (NCPB)<br>* 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.<br>|
| Active Comparator: NCPB<br>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)<br>* 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.<br>|

What is the study measuring?
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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 |