Clinical Trial: The Treatment of Recurrent Abdominal Pain in Children

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: The Treatment of Recurrent Abdominal Pain in Children: A Comparison of Biofeedback and Behavioral Intervention

Brief Summary: The purpose of this study is to determine if two treatments, a biofeedback and behavioral protocol, for recurrent abdominal pain are equally effective.

Detailed Summary: Recurrent abdominal pain (RAP) is a functional disorder that affects approximately 10 to 25% of children in the United States. This population tends to be heavy medical users in a search of a treatment for the chronic pain, but at this time there is no standard treatment protocol. The literature proposes that there are two effective treatments for RAP, a relaxation protocol by Sanders et al. (1994) and a biofeedback protocol currently in use at Kaiser, but neither treatment has been widely accepted as standard treatment. A purpose of this study is to gather more data on both treatments to help move one or both treatments into the standard of care for RAP. The hypothesis of this study is that the biofeedback and the relaxation protocols will have equivalent treatment outcomes.
Sponsor: Kaiser Permanente

Current Primary Outcome: The measurable primary outcome will use equivalency testing on changes in pain diary ratings, using the average weekly pain intensity and frequency as recorded in the pain dairy [ Time Frame: 3 Months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: A measurable secondary outcome will be changes in heart rate variability [ Time Frame: 3 Months ]

Original Secondary Outcome: Same as current

Information By: Kaiser Permanente

Dates:
Date Received: February 26, 2009
Date Started: March 2009
Date Completion:
Last Updated: June 19, 2015
Last Verified: December 2010