Acupuncture Treatment for Gastroparesis: a Pilot Study

NCT ID: NCT01643577

Last Updated: 2016-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-11-30

Brief Summary

Gastroparesis is a disorder characterized by delayed gastric emptying leading to symptoms of nausea, vomiting, bloating, and abdominal pain. A common cause is diabetes but even more often it occurs in otherwise healthy individuals. The symptoms of gastroparesis can significantly alter a patient's quality of life. Current therapies are limited. In this study, the investigators seek to determine if twice weekly acupuncture treatments can improve symptoms of gastroparesis.

Detailed Description

Gastroparesis is a disorder characterized by delayed gastric emptying leading to symptoms of nausea, vomiting, bloating, and abdominal pain. A common cause is diabetes but often it occurs in otherwise healthy individuals in whom the disorder is said to be idiopathic. The symptoms of gastroparesis can significantly alter a patient's quality of life and may result in absenteeism or frequent ER visits and hospitalizations for dehydration caused by intractable nausea and vomiting.

Current treatment for gastroparesis includes dietary and lifestyle modifications, tight glycemic control in diabetics, and supportive care for symptoms, like anti-emetics for nausea. Prokinetic therapies to enhance gastric emptying such as metoclopramide, domperidone, and erythromycin have varying degrees of effect. Unfortunately they are often limited by side effects. Metoclopramide, the only pharmacologic agent that is FDA approved for the treatment of gastroparesis, in particular crosses the blood brain barrier and may cause CNS side effects, reported to be 10-25% of the time. The most rare but most worrisome adverse reaction is tardive dyskinesia associated with prolonged use of metoclopramide, prompting the FDA to label it with a blackbox warning. Use of erythromycin is limited to acute flares, as prolonged use causes tachyphylaxis. Finally, domperidone may have equal efficacy as metoclopramide and is available in 58 countries. However, it is not FDA approved in the US but can be obtained with an Investigational New Drug Application. Given these constraints, novel therapies to improve symptoms are needed.

Preliminary studies from Asia and the US have shown a potential role for acupuncture in improving gastroparetic symptoms and gastric motility in diabetic and non-diabetic patients. It is our plan to expand on the available research by using validated instruments to measure changes in severity of symptoms and quality of life, incorporating randomization and blinding, and correcting for possible placebo effect.

Our hypothesis is that twice weekly acupuncture treatments can improve symptoms of gastroparesis with an effect that lasts beyond the last treatment date without inducing side-effects. We also hypothesize that gastric emptying may improve compared to baseline values. This is a pilot study of 20 gastroparetic patients who will be randomized to standard medical therapy + acupuncture designed to treat gastroparesis vs. standard medical therapy + acupuncture designed to treat unrelated musculoskeletal and arthralgia complaints.

Conditions

Gastroparesis; Nausea; Vomiting; Abdominal Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Acupuncture protocol for gastroparesis

Patients randomized to this arm will receive an acupuncture protocol that with points designed to treat gastroparesis

Group Type: ACTIVE_COMPARATOR

Acupuncture for gastroparesis

Intervention Type: PROCEDURE

A series of acupuncture points selected for the treatment of gastroparesis will be used at each of the 10 acupuncture sessions

Acupuncture for musculoskeletal pain

Patients randomized to this arm will receive acupuncture therapy consisting of points designed to treat musculoskeletal pain.

Group Type: PLACEBO_COMPARATOR

Acupuncture for musculoskeletal pain

Intervention Type: PROCEDURE

Acupuncture points selected for the treatment of musculoskeletal pain will be used during each of the 10 acupuncture sessions

Interventions

Acupuncture for gastroparesis

A series of acupuncture points selected for the treatment of gastroparesis will be used at each of the 10 acupuncture sessions

Intervention Type: PROCEDURE

Acupuncture for musculoskeletal pain

Acupuncture points selected for the treatment of musculoskeletal pain will be used during each of the 10 acupuncture sessions

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Participants will be at least 18 years old and able to provide informed consent.
• Participants will have symptoms of idiopathic gastroparesis for at least 6 months duration prior to enrollment with documented abnormal solid phase gastric emptying scintigraphy

Exclusion Criteria

• Gastroparesis due to: diabetes, medication (e.g. post-chemotherapy), iatrogenic post-surgical gastroparesis, and severe neurologic conditions such as Parkinson's disease known to be associated with gastroparesis.
• An active eating disorder,
• Participants currently lactating, or preparing to conceive will also be excluded.
• A history of inflammatory bowel disease
• Known bowel obstruction, or strictures

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Linda A. Lee, MD

Principal Investivator, Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Johns Hopkins Integrative Medicine & Digestive Center

Lutherville, Maryland, United States

Countries

United States

Other Identifiers

NA_00044436

Identifier Type: -

Identifier Source: org_study_id