Acupuncture Treatment for Gastroparesis: a Pilot Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Johns Hopkins University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Linda A. Lee, MD, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01643577
First received: June 26, 2012
Last updated: July 16, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Gastroparesis
Nausea
Vomiting
Abdominal Pain
Procedure: Acupuncture for gastroparesis
Procedure: Acupuncture for musculoskeletal pain
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Acupuncture Treatment for Gastroparesis: a Pilot Study

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Symptomatic improvement using GCSI [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    To determine whether acupuncture treatment designed to treat gastroparesis significantly improves symptoms of gastroparesis measured by the Gastroparesis cardinal symptoms index (GCSI)


Secondary Outcome Measures:
  • Gastric emptying time [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
    To determine whether acupuncture treatment designed to treat gastroparesis significantly improves gastric emptying measured by the Smart Pill

  • Small bowel and colonic transit time [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
    To determine whether acupuncture treatment designed to treat gastroparesis significantly alters small bowel and colonic motility using Smart Pill


Estimated Enrollment: 20
Study Start Date: November 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Acupuncture protocol for gastroparesis
Patients randomized to this arm will receive an acupuncture protocol that with points designed to treat gastroparesis
Procedure: Acupuncture for gastroparesis
A series of acupuncture points selected for the treatment of gastroparesis will be used at each of the 10 acupuncture sessions
Placebo Comparator: Acupuncture for musculoskeletal pain
Patients randomized to this arm will receive acupuncture therapy consisting of points designed to treat musculoskeletal pain.
Procedure: Acupuncture for musculoskeletal pain
Acupuncture points selected for the treatment of musculoskeletal pain will be used during each of the 10 acupuncture sessions

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01643577

Contacts
Contact: Linda A Lee, MD 410-321-1082 llee12@jhmi.edu
Contact: Jeff Gould, LAc 410-828-3585 jgould@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Integrative Medicine & Digestive Center Recruiting
Lutherville, Maryland, United States, 21093
Contact: Aisha Craig, BA    410-828-3585    adudley5@jhmi.edu   
Principal Investigator: Linda A Lee, MD         
Sponsors and Collaborators
Johns Hopkins University
  More Information

No publications provided

Responsible Party: Linda A. Lee, MD, Principal Investivator, Associate Professor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01643577     History of Changes
Other Study ID Numbers: NA_00044436
Study First Received: June 26, 2012
Last Updated: July 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Idiopathic
gastroparesis
delayed gastric emptying
nausea
vomiting
abdominal pain
bloating

Additional relevant MeSH terms:
Gastroparesis
Abdominal Pain
Nausea
Vomiting
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations

ClinicalTrials.gov processed this record on August 25, 2014