A Study to Evaluate the Role of Alternative Medicine in Difficult to Treat GERD Patients - Full Text View

Sponsor:	Kansas City Veteran Affairs Medical Center
Information provided by:	Kansas City Veteran Affairs Medical Center
ClinicalTrials.gov Identifier:	NCT00591877

Purpose

Patients with refractory GERD on BID PPI's assigned to the acupuncture group will have significant improvement in their symptoms after receiving acupuncture for 6 weeks as compared to sham acupuncture given for the same duration.

Primary Aim 1:To determine the efficacy of acupuncture in the treatment of refractory GERD.

Participants with refractory GERD on BID PPIs randomized to yoga will have a significant relief in the symptoms of reflux.

Primary Aim 2:To determine the efficacy of yoga in the treatment of refractory GERD.

Condition	Intervention
Gastroesophageal Reflux Disease	Procedure: Acupuncture Procedure: Sham Acupuncture Other: Yoga

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	A Study to Evaluate the Role of Alternative Medicine in Difficult to Treat GERD Patients

Resource links provided by NLM:

MedlinePlus related topics: Acupuncture Esophagus Disorders GERD

U.S. FDA Resources

Further study details as provided by Kansas City Veteran Affairs Medical Center:

Primary Outcome Measures:

Decrease by 50% in the RDQ scores as compared to baseline at the end of the study period [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Improvement in reflux related quality of life (QOLRAD) scores at the end of the study by 50% [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Decrease by 50% in the baseline RDQ scores at 12 and 26 week follow up after the completion of the study [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	45
Study Start Date:	May 2007
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
AC: Active Comparator Acupuncture: The patients will receive acupuncture by a trained doctor with acupuncture expertise, at 3 points relevant to reflux symptoms. Each patient will undergo a 30 minute session, twice a week, for a total of 12 sessions. The technique will involve electro-stimulation at predefined points followed by needle manipulation.	Procedure: Acupuncture Each patient will undergo a 30 minute session, twice a week, for a total of 12 sessions. The technique will involve electro-stimulation at predefined points followed by needle manipulation. The acupoints that will be used are: ST-36: 3 finger breadths inferior to lower edge of patella between tibialis anterior muscle and the tibia, 1 finger breadth lateral to the anterior crest of the tibia. PC-6: 2 finger breadths proximal to and in the middle of the most distal transverse crease of the wrist, between the tendons of palmaris longus and flexor carpi radialis. CV-12: 4 finger breadths superior to the umbilicus.
SAC: Sham Comparator The patients randomized to this arm will receive acupuncture for a similar duration and number of sessions. The sham acupoints are at least 2 cm away from the actual acupoints to prevent acupressure effects	Procedure: Sham Acupuncture The acupoints for SAC are: LI-4 : adjacent to and at the middle of the radial side of the 2nd metacarpal bone, at the same level as the end of the crease when the thumb and index fingers approximate. GB-32: on the lateral aspect of the thigh 5 finger breadths proximal to the popliteal crease, 2 finger breadths inferior to GB31. UB -15: 1.5 finger breadths lateral to the midline of the spine on a level between the 5 th and the 6 th thoracic vertebrae.
Yoga: Active Comparator The participants in this arm will undergo a 60 min session of yoga exercises. These exercises are specifically designed for reflux symptoms by a yoga instructor. This includes a set of specific physical postures (asana) and breathing techniques within the four-element setup. The set of asana are divided into (a) standing, (b) sitting, and (c) lying down positions. The session will begin with asana in standing position, followed by a position called Shavasan (relaxation), then asana in sitting down position followed by Shavasan, finally asana in lying down position followed by Shavasan. At the end of all asana, Pranayam (special breathing exercises) will be practiced.	Other: Yoga The participants in this arm will undergo a 60 min session of yoga exercises. These exercises are specifically designed for reflux symptoms by a yoga instructor. This includes a set of specific physical postures (asana) and breathing techniques within the four-element setup. The set of asana are divided into (a) standing, (b) sitting, and (c) lying down positions. The session will begin with asana in standing position, followed by a position called Shavasan (relaxation), then asana in sitting down position followed by Shavasan, finally asana in lying down position followed by Shavasan. At the end of all asana, Pranayam (special breathing exercises) will be practiced.

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 yrs or older.
agreeable to randomization.
patients with refractory GERD on bid PPI.
negative endoscopy in the last 5 yrs.
able to follow simple instructions and perform simple exercises.
capable of giving informed consent.

Exclusion Criteria:

GERD with known complications e.g. peptic stricture.
Hepatitis C
HIV
Peripheral neuropathy.
Irritable bowel syndrome
Previous acupuncture.
any other major co morbidity e.g. scleroderma etc.
chronic anticoagulation
pregnancy/lactation
prior h/o esophageal surgery.
H/o of Barrett's esophagus.
Esophageal cancer

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00591877

Contacts

Contact: April Higbee, RN

816 861 4700 ext 57456

april.higbee@va.gov

Locations

United States, Missouri
Kansas city VA Medical center	Recruiting
Kansas city, Missouri, United States, 64128
Contact: April Higbee, RN 816-861-4700 ext 57456 april.higbee@va.gov
Sub-Investigator: Amit Rastogi, MD
Sub-Investigator: Ajay Bansal, MD
Sub-Investigator: Prashant Pandya, MD
Sub-Investigator: Sachin Wani, MD
Sub-Investigator: Santosh Sharma, MD
Sub-Investigator: Keith Rastogi, MD
Principal Investigator: Prateek Sharma, MD

Sponsors and Collaborators

Kansas City Veteran Affairs Medical Center

Investigators

Principal Investigator:

Prateek Sharma, MD

Kansas city VA Medical Center

More Information

No publications provided

Responsible Party:	Kansas city VA Medical Center ( Prateek Sharma )
Study ID Numbers:	PS0045
Study First Received:	December 27, 2007
Last Updated:	February 3, 2009
ClinicalTrials.gov Identifier:	NCT00591877 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Kansas City Veteran Affairs Medical Center:

GERDCAM: Complementary and alternative medicine.
NERD: non-erosive reflux disease.
GERD: gastroesophageal reflux disease.
AC: acupuncture.
SAC: sham acupuncture.

LES: lower esophageal sphincter pressure.
TLESR: transient lower esophageal sphincter relaxation
Acupuncture
Yoga

Additional relevant MeSH terms:

Deglutition Disorders
Esophageal Motility Disorders
Digestive System Diseases

Gastrointestinal Diseases
Esophageal Diseases
Gastroesophageal Reflux

ClinicalTrials.gov processed this record on February 08, 2010