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

Daegu Catholic University Medical Center

Status: Completed

Conditions: Abdominal Pain

Treatments: Procedure: Neurolytic celiac plexus block (NCPB); Device: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT01913574

CIMI-13-01-09

Details and patient eligibility

About

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

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Acupuncture & NCPB

Experimental group

Description:

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).

Treatment:

Procedure: Neurolytic celiac plexus block (NCPB)

Device: Acupuncture

NCPB

Active Comparator group

Description:

The NCPB alone will be applied to the patients in this group, once at the start of the trial.

Treatment:

Procedure: Neurolytic celiac plexus block (NCPB)