Acupuncture Treatment for Gastroparesis: a Pilot Study

NCT01643577 | Completed Phase 1

• 1 other identifier: NA_00044436
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroparesis; Nausea; Vomiting; Abdominal Pain

Keywords

Idiopathic; gastroparesis; delayed gastric emptying; nausea; vomiting; abdominal pain; bloating

Outcome Measures

Primary Outcomes (1)

• Symptomatic improvement using GCSI

  To determine whether acupuncture treatment designed to treat gastroparesis significantly improves symptoms of gastroparesis measured by the Gastroparesis cardinal symptoms index (GCSI)

  10 weeks

Secondary Outcomes (2)

• Gastric emptying time

  5 weeks

• Small bowel and colonic transit time

  5 weeks

Study Arms (2)

Acupuncture protocol for gastroparesis

ACTIVE COMPARATOR

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

Procedure: Acupuncture for gastroparesis

Acupuncture for musculoskeletal pain

PLACEBO COMPARATOR

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

Procedure: Acupuncture for musculoskeletal pain

Interventions

Acupuncture for gastroparesis PROCEDURE

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

Acupuncture protocol for gastroparesis

Acupuncture for musculoskeletal pain PROCEDURE

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

Acupuncture for musculoskeletal pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Integrative Medicine & Digestive Center

Lutherville, Maryland, 21093, United States

Location

MeSH Terms

Conditions

Gastroparesis; Nausea; Vomiting; Abdominal Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Pain

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investivator, Associate Professor of Medicine

Study Record Dates

• First Submitted: June 26, 2012
• First Posted: July 18, 2012
• Study Start: November 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: September 2, 2016

Record last verified: 2016-08

Locations

US (1)