Migraine and Recurrent Abdominal Pain in Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2003 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00060619
First received: May 8, 2003
Last updated: June 23, 2005
Last verified: March 2003
  Purpose

This study will evaluate a new model for assessing and treating migraine and recurrent abdominal pain in children. The model combines behavioral techniques such as relaxation training with biologic components such as thermal biofeedback.


Condition Intervention
Migraine
Abdominal Pain
Behavioral: thermal biofeedback
Behavioral: relaxation training
Behavioral: cognitive coping skills
Behavioral: parent education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Treatment of Recurrent Pain Syndromes in Children

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Estimated Enrollment: 180
Study Start Date: May 1999
Estimated Study Completion Date: June 2004
Detailed Description:

Recurrent pain syndromes (RPS) are relatively common in pediatric populations. Two of the most common types of RPS are recurrent abdominal pain (RAP) and migraine. Similar patterns of pain are described in children with RAP and migraine, and similar factors (particularly stress) may initiate both types of RPS.

This study will assess a new biobehavioral model for evaluating and treating children with RPS. This model relates precipitating, intervening, and functional status factors in chronic and recurring pain in children. The model proposes that stress is a precipitant of pain. This study will evaluate the model in children who receive therapy for RPS that is based on stress management strategies. The therapy includes relaxation training, cognitive coping skills training, thermal biofeedback, and parent education. It will be compared to a control treatment program of hand-cooling biofeedback and supportive therapy.

Consenting participants will be randomized to receive either biobehavioral therapy or control therapy. Participants will have 6 study visits over the course of 2 months. The first study visit is an evaluation visit; the remaining five study visits are treatment visits. Participants will be followed for 24 months and will be asked to complete mail-in forms at Months 3, 6, 12, and 24.

Participants will be recruited through local pediatricians, pediatric neurologists, and pediatric gastroenterologists. Brochures about the study will be sent to these physicians to pass on to their patients informing them about the study. Children in the control group will be recruited through Children's Hospital outpatient clinics.

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Migraine or functional abdominal pain of at least 3 months duration, occurring at least weekly or 5 days per month
  • Child assent
  • Parental consent

Exclusion Criteria

  • Medical illnesses that cause similar pain symptoms (e.g., inflammatory bowel disease, brain cancer)
  • Psychiatric diagnosis that would interfere with participation in the study (any Axis I diagnosis of moderate severity)
  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: NCT00060619

Locations
United States, Massachusetts
Pain Treatment Service, Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Lisa Scharff, Ph.D.    617-355-2470    lisa.scharff@tch.harvard.edu   
Contact: Clorinda Schenck    617-355-8973    clorinda.schenck@tch.harvard.edu   
Sponsors and Collaborators
Investigators
Principal Investigator: Lisa Scharff, Ph.D. Harvard University
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00060619     History of Changes
Other Study ID Numbers: 5R01HD38647-3
Study First Received: May 8, 2003
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Migraine
Functional abdominal pain
Biofeedback
Psychological assessment

Additional relevant MeSH terms:
Abdominal Pain
Migraine Disorders
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 24, 2014