NCT00591877

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 27, 2007

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 11, 2008

Completed
4.9 years until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

October 26, 2012

Status Verified

October 1, 2012

Enrollment Period

1.4 years

First QC Date

December 27, 2007

Last Update Submit

October 25, 2012

Conditions

Gastroesophageal Reflux Disease

Keywords

GERDCAM: Complementary and alternative medicineNERD: non-erosive reflux diseaseGERD: gastroesophageal reflux diseaseAC: acupunctureSAC: sham acupunctureLES: lower esophageal sphincter pressureTLESR: transient lower esophageal sphincter relaxationAcupunctureYoga

Outcome Measures

Primary Outcomes (1)

  • Decrease by 50% in the RDQ scores as compared to baseline at the end of the study period

    1 year

Secondary Outcomes (2)

  • Improvement in reflux related quality of life (QOLRAD) scores at the end of the study by 50%

    1 year

  • Decrease by 50% in the baseline RDQ scores at 12 and 26 week follow up after the completion of the study

    1 year

Study Arms (3)

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

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

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

Interventions

AcupuncturePROCEDURE

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.

Also known as: AC
AC
Sham AcupuncturePROCEDURE

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.

Also known as: SAC
SAC
YogaOTHER

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.

Yoga

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients must be a Kansas City VA Hospital patient.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kansas city VA Medical center

Kansas City, Missouri, 64128, United States

Location

MeSH Terms

Conditions

Gastroesophageal RefluxNon-Erosive Reflux Disease

Interventions

Acupuncture TherapyYoga

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsMind-Body TherapiesSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Prateek Sharma, MD

    Kansas City VA Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 27, 2007

First Posted

January 11, 2008

Study Start

December 1, 2012

Primary Completion

May 1, 2014

Study Completion

January 1, 2015

Last Updated

October 26, 2012

Record last verified: 2012-10

Locations

US(1)