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Migraine and Recurrent Abdominal Pain in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00060619
Recruitment Status : Unknown
Verified March 2003 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was:  Recruiting
First Posted : May 12, 2003
Last Update Posted : June 24, 2005
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Brief Summary:
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 or disease Intervention/treatment
Migraine Abdominal Pain Behavioral: thermal biofeedback Behavioral: relaxation training Behavioral: cognitive coping skills Behavioral: parent education

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Treatment of Recurrent Pain Syndromes in Children
Study Start Date : May 1999
Estimated Study Completion Date : June 2004

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U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00060619

United States, Massachusetts
Pain Treatment Service, Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Lisa Scharff, Ph.D.    617-355-2470   
Contact: Clorinda Schenck    617-355-8973   
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Lisa Scharff, Ph.D. Harvard University

Publications: Identifier: NCT00060619     History of Changes
Other Study ID Numbers: 5R01HD38647-3
First Posted: May 12, 2003    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: March 2003

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

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